Digitally enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial.

BACKGROUND: Digitally enabled rehabilitation may lead to better outcomes but has not been tested in large pragmatic trials. We aimed to evaluate a tailored prescription of affordable digital devices in addition to usual care for people with mobility limitations admitted to aged care and neurological rehabilitation. METHODS AND
FINDINGS: We conducted a pragmatic, outcome-assessor-blinded, parallel-group randomised trial in 3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation. Both the intervention and control groups received usual multidisciplinary inpatient and post-hospital rehabilitation care as determined by the treating rehabilitation clinicians. In addition to usual care, the intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices for 6 months in hospital and at home. Co-primary outcomes were mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL) at 6 months. The dataset was analysed using intention-to-treat principles. The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000936628). Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation) were randomly assigned to intervention (n = 149) or control (n = 151) using a secure online database (REDCap) to achieve allocation concealment. Six-month assessments were completed by 258 participants (129 intervention, 129 control). Intervention participants received on average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge. Changes in mobility scores were higher in the intervention group compared to the control group from baseline (SPPB [continuous, 0-3] mean [SD]: intervention group, 1.5 [0.7]; control group, 1.5 [0.8]) to 6 months (SPPB [continuous, 0-3] mean [SD]: intervention group, 2.3 [0.6]; control group, 2.1 [0.8]; mean between-group difference 0.2 points, 95% CI 0.1 to 0.3; p = 0.006). However, there was no evidence of a difference between groups for upright time at 6 months (mean [SD] proportion of the day spent upright at 6 months: intervention group, 18.2 [9.8]; control group, 18.4 [10.2]; mean between-group difference -0.2, 95% CI -2.7 to 2.3; p = 0.87). Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life. No adverse events were reported in the intervention group. Thirteen participants died while in the trial (intervention group: 9; control group: 4) due to unrelated causes, and there was no evidence of a difference between groups in fall rates (unadjusted incidence rate ratio 1.19, 95% CI 0.78 to 1.83; p = 0.43). Study limitations include 15%-19% loss to follow-up at 6 months on the co-primary outcomes, as anticipated; the number of secondary outcome measures in our trial, which may increase the risk of a type I error; and potential low statistical power to demonstrate significant between-group differences on important secondary patient-reported outcomes.
CONCLUSIONS: In this study, we observed improved mobility in people with a wide range of health conditions making use of digitally enabled rehabilitation, whereas time spent upright was not impacted. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Register; ACTRN12614000936628.

RCT Entities:   Population Interventions Outcomes

Introduction

Over 20% of the world population will be >60 years of age by 2050 [1]. Many will need accessible and affordable rehabilitation to reduce costly limitations in function from neurological and musculoskeletal health conditions [2] as well as decline from aging and inactivity [3]. Physical rehabilitation should contain intensive, repetitive task-specific exercises to improve outcomes [4-7]. Virtual reality video games, activity monitors, and handheld computer devices are accessible, affordable, and enjoyable [8], and together can provide a digitally enabled rehabilitation environment by providing more opportunity and greater motivation to increase task-specific practice in hospital [9] and in the home setting [10]. However, evidence of their impact on outcomes is limited and focused on stroke rehabilitation [11,12]. A systematic review of virtual reality interventions in people after stroke (72 studies) demonstrated a moderate effect on balance, but no effect on walking speed or global motor function when delivered as an adjunct to usual rehabilitation [11]. However, the quality of evidence was rated as low for nearly all outcomes, and all but 1 study tested a single virtual reality system. A feasibility trial conducted by our team in people undertaking inpatient aged care and neurological rehabilitation (n = 58) provided an additional dose of rehabilitation for 2 weeks using a range of low-cost video games and activity monitors [13]. The intervention was feasible, safe, and enjoyable, and enabled a higher dose of exercise and improved balance but not overall mobility. This promising intervention, after refinement, required rigorous evaluation.

The primary aim of the Activity and MObility UsiNg Technology (AMOUNT) trial was to test the effectiveness of tailored prescription of affordable devices to improve mobility and physical activity in people with mobility limitations undertaking aged care and neurological rehabilitation. The devices were prescribed in addition to usual care and compared to usual care alone.

Methods

Design

AMOUNT was a pragmatic, assessor-blinded, multicentre superiority randomised controlled trial with 2 parallel groups and included a nested economic analysis (presented separately) and a qualitative study [14].

Sites, staff, and participants

There were 3 trial sites across Australia. Two were in metropolitan hospitals in Sydney in New South Wales (Site 1: 20-bed stroke and 20-bed aged care rehabilitation wards; Site 2: 16-bed brain injury rehabilitation unit), and 1 was in Adelaide in South Australia (Site 3: 30-bed geriatric evaluation and management ward and 40- and 20-bed general rehabilitation wards). Research physiotherapists recruited participants, conducted baseline assessments, randomised participants, and delivered the intervention; all were experienced physiotherapists and received training in trial processes, as well as in the digital intervention to be delivered.

Consecutive patients admitted to the units who met the following criteria were invited to participate: ≥18 years old; reduced mobility (Short Physical Performance Battery [SPPB] score < 12) [15] with clinician-assessed capacity for improvement (based on the usual care physiotherapists’ clinical experience and their assessment and treatment experience with the patient); life expectancy > 12 months; anticipated length of stay ≥ 10 days from randomisation; and able to maintain a standing position (with assistance of 1 person if necessary). Patients were excluded if they had any of the following: cognitive impairment likely to interfere with device use; insufficient English language skills with no available interpreter; inadequate vision to use devices; medical condition(s) precluding exercise; no interest in using devices; anticipated discharge to high care residential facility (nursing home); or discharge location too distant for follow-up.

Randomisation

A staff member external to the trial prepared the randomisation schedule using randomly permuted block sizes of 2, 4, and 6 and incorporating stratification for study site and health condition (whether or not the person had a neurological health condition affecting mobility). Following written informed consent and baseline assessment, research staff completed web-based randomisation (allocation concealment) to determine group allocation.

Intervention

Both the intervention and control groups received usual rehabilitation care, which was determined by the treating clinicians and included assessment and prescription of a series of repetitive exercises by the physiotherapist, tailored management by the multidisciplinary team, and a fall prevention brochure [16] (see Table 1). In addition, the intervention group was prescribed 30 to 60 minutes of digitally enabled rehabilitation 5 days per week in hospital and post-discharge, defined as rehabilitation using digital devices (e.g., virtual reality, wearables, and tablet and smartphone applications), with remote monitoring and communication post-discharge. The intervention group was prescribed exercises using virtual reality video games, activity monitors, and handheld computer devices to enhance mobility and physical activity. The exercises and devices were individually prescribed by a trial physiotherapist according to an intervention protocol that matched different task-specific exercises on different devices to common mobility limitations. The physiotherapist also considered participant impairments (e.g., upper limb weakness, hemianopia) and contextual factors such as participant goals, device preferences, and the home environment. Included devices were purchased by the research team or constructed for less than US$3,700 each. Participants could use any number of devices as guided by the physiotherapist. Devices were loaned to participants to use at home and were progressed or changed as required. For further details of usual care and the additional intervention using digital devices, see Table 1 and S1 Text, and the published protocol [17].

Table 1

Intervention description using the template for intervention description and replication (TIDieR) checklist.

Checklist item	Intervention group		Control group
	Inpatient setting	Post-hospital setting	Inpatient setting	Post-hospital setting
Brief name	Digitally enabled rehabilitation in addition to usual care.		Usual care.
Why	Digital devices potentially provide an affordable way to increase the dose of practice for better rehabilitation outcomes. Devices such as virtual reality video games, activity monitors, and handheld computer devices enhance enjoyment of exercise and provide feedback for motor relearning.		Pragmatic trial design.
What
Materials for therapists	A detailed intervention protocol that matched mobility limitations with different devices and games/exercises within those devices. Training in health coaching by an external provider or previously trained therapists. Research managers provided ongoing training on the use of the devices, clinical reasoning, and health coaching.		Clinical therapists were provided with information on the trial protocol and asked not to use devices to improve mobility or physical activity as part of their usual care intervention.
Materials for participants	Participants were (1) provided with a fall prevention brochure on discharge from hospital [16]; (2) loaned devices for the duration of the trial; (3) provided with trial-developed practice sheets and information sheets on how to use the different devices; (4) prescribed mobility exercises and/or physical activity using devices in addition to usual care. Recreational devices: Nintendo Wii (Nintendo, Kyoto, Japan); Xbox Kinect (Microsoft, Redmond, Washington, US); Fitbit Zip, One, and Alta (Fitbit, San Francisco, California, US); Garmin Vivofit (Garmin, Olathe, Kansas, US); Runkeeper mobile phone application (FitnessKeeper, Boston, Massachusetts, US). Rehabilitation devices: Humac Balance System (CSMi Solutions, Stoughton, Massachusetts, US); Fysiogaming (Doctor Kinetic, Amsterdam, the Netherlands). Investigator-developed devices: Stepping Tiles (University of Technology Sydney, Sydney, Australia); T-Rex iPad exercise application (Repatriation General Hospital, Adelaide and Sydney, Australia); AMOUNT iPad exercise application (University of Sydney, Sydney, Australia); Walk Forward iPhone application (The George Institute for Global Health and Telstra Health, Sydney, Australia).		Participants were (1) provided with a fall prevention brochure on discharge from hospital [16]; (2) provided with inpatient usual care at the 3 study sites involving assessment and prescription of a series of repetitive exercises (e.g., practice of standing up or stepping); (3) referred to usual outpatient therapy as clinically required. Usual care also included assessment and tailored management by medical specialists, nurses, occupational therapists, speech pathologists, social workers, nutritionists, orthoptists, and other health professionals as required.
Who provided	Physiotherapists employed on the trial.		Physiotherapists employed at the study site hospitals.	No intervention or physiotherapists employed at the study site hospitals or private physiotherapists.
How	Face-to-face sessions.	Face-to-face and remote sessions following a health coaching model.	A mix of one-on-one, semi-supervised, independent, and group-based sessions.
Where	Inpatient rehabilitation gym.	Remotely by phone/email/video conferencing or in person at the participant’s discharge destination (home, transitional living unit, residential care).	Inpatient rehabilitation gym.	No intervention or outpatient rehabilitation gym, at the participant’s discharge destination or in the community.
When and how much	≥5 times per week for ≥30 minutes per session with physiotherapy supervision or monitoring.	≥5 times per week for ≥30 minutes per session independently or with carer support. Research physiotherapists provided support using health coaching model every 1–2 weeks depending on participant needs and preferences.	Participants were seen as required by their treating physiotherapist: typically, ≥1 session per day Monday to Friday (and weekends for 1 site).	Participants who required ongoing physiotherapy were seen by outpatient/domiciliary physiotherapy services as required.
Tailoring	The intervention was tailored for each participant to address current mobility limitations and physical inactivity, considering participant goals, device preferences, and contextual factors (e.g., home environment).		Determined by treating physiotherapist.
Modifications	As planned, the intervention protocol was modified during the trial; version 2 (published 14 October 2015) and version 3 (published 23 February 2016). Modifications included adding new games (e.g., Game Trainer for Nintendo Wii), a new iPhone application (Walk Forward), and upgrades of devices (e.g., software updates and rollout of a home-based version for Fysiogaming). Health coaching was initially prescribed weekly but changed within the first 6 months of the trial to ‘as required’ with a recommendation of weekly initially, reducing the frequency over time if the participant was managing well. This was modified due to experience in the trial and matched the tailored nature of the intervention (see S2 Text).		Not applicable.
Trial fidelity	Fidelity checking by site research managers (LH and MvdB) entailed observation of intervention sessions (inpatient and community), review of intervention data sheets with feedback/discussion, site weekly/fortnightly team meetings, combined-site quarterly meetings with case studies, practical sessions with devices, review of intervention protocol, and regular phone meetings between site research managers.		Clinical practice sheets were collected from staff at the 2 sites in New South Wales (where it was usual practice for therapists to provide practice sheets) to assess usual physiotherapy care. Participants were questioned regarding their device use at the time of hospital discharge, and at the end of the trial intervention.

Outcome measures

Face-to-face outcome assessments were conducted at 3 weeks and 6 months after randomisation and by mail or telephone at 12 weeks after randomisation. Outcome assessors were registered health professionals trained in conducting the outcome assessments, external to the clinical sites, and blinded to group allocation. The face-to-face assessments were conducted in the hospital if the participant was still an inpatient, or at the post-hospital-discharge destination (e.g., home, transitional living unit). Prior to the outcome assessor completing the 6-month assessment, the intervention devices were removed from participant homes and participants were reminded not to discuss their trial involvement with the assessor.

Primary outcomes

The co-primary outcomes were mobility and physical activity (upright time) 6 months after randomisation. Mobility is a broad term that is defined as the ability to move around and change positions, such as to stand up from sitting and to walk. Mobility was assessed with the performance-based SPPB (continuous version), also known as the lower extremity continuous summary performance score, which uses actual time taken to complete mobility tasks [18]. Scores range from 0 (worst performance) to 3 (best performance) and are based on timed gait speed over 4 metres; standing balance with feet positioned parallel, semi-tandem, and tandem; and standing up from a chair 5 times. The SPPB has high levels of validity, reliability, and responsiveness in measuring mobility in older people living in the community, is increasingly used in trials involving older adults [19], and can predict falls risk, disability, and death [20]. The 12-point version of the SPPB is most commonly used, and 0.5- to 1-point changes have been suggested to be clinically meaningful. We used the continuous version as it has been suggested as more likely to be able to detect change [18].

Physical activity was assessed over a 7-day period at the end of the 6-month intervention period using the activPAL activity monitor (PAL Technologies, UK) [21]. The measure of physical activity was ‘upright time’, defined as the average proportion of the day spent standing and stepping, measured in 10-second minimum periods. Upright time was chosen as our primary physical activity measure, rather than steps per day, as not all trial participants were expected to be able to walk independently, and we sought to use a measure that could be used at all study time points.

Secondary outcomes

Secondary outcomes were performance-based measures assessed at 3 weeks and 6 months after randomisation and participant-reported measures assessed at 3 and 12 weeks and 6 months after randomisation. Performance-based measures of mobility included SPPB (continuous) at 3 weeks; SPPB total score (0 to 12 based on categorisation of performance times; higher score indicates better mobility; clinically important difference 0.5 points) [15,20] and subscale scores (0 to 4) [19]; de Morton Mobility Index (0 to 100; higher score indicates better mobility; clinically important difference 7 to 8 points) [22-24]; single leg stance (0 to 10 seconds; greater time indicates better mobility); maximal balance range test (millimetres; greater distance indicates better mobility) [25]; and step test (number of steps; greater number of steps indicates better mobility) [26]. Performance-based measures of physical activity included proportion of the day spent upright at 3 weeks, average time spent standing and stepping, number of steps per day, and number of sit to stand transitions per day measured using the activPAL [21]. Performance-based measures of cognition included Trail Making Test A, B, and B − A (seconds; quicker time indicates improved cognition) [27,28].

Participant-reported measures included Incidental and Planned Exercise Questionnaire (IPEQ) total score and home exercise and walking activity subscale scores (hours/week) [29]; Modified Computer Self Efficacy Scale (10 to 100; higher score indicates improved device self-efficacy) [30]; Activities-specific Balance Confidence Scale (0 to 100; higher score indicates improved confidence) [31]; WHO Disability Assessment Schedule 2.0 (12 to 60; lower score indicates improved activity performance and participation) [32,33]; Short Form 6 dimensions questionnaire subscale scores and health utility score (0 to 1; higher score indicates better quality of life; mean minimal important difference 0.041) [34,35]; and European Quality of Life–5 dimensions subscale scores, visual analogue scale score (0 to 100), and health utility score (−0.68 to 1; higher score indicates better quality of life; minimal important difference 0.074) [35,36]. In addition, falls and health and community service usage were assessed over the 6-month period. Adverse events in the intervention group and deaths in both groups were monitored and documented throughout the trial. Adverse events were defined as an unwanted and usually harmful outcome (e.g., fall, seizure, cardiac event) that may or may not be related to the intervention, but occurred while the participant was undertaking mobility or physical activities using intervention digital devices. Self-reported measures of device usability (System Usability Scale; 0 to 100; score above 70 indicates above average usability) [37,38] and enjoyment (Physical Activity Enjoyment Scale; 18 to 126; higher score indicates more enjoyment) [39] were obtained from the intervention group at 3 and 12 weeks and 6 months after randomisation.

Data analysis

We estimated that a sample size of 300 participants (150 per group) would provide 90% power to detect a 15% between-group difference in the co-primary outcome measures, allowing for a 20% dropout rate and an alpha of 5%. This sample size was also estimated to be sufficient to detect between-group differences of 10%–15% in most secondary outcomes and was considered by the authors to be of meaningful size on the basis of our collective clinical experience with the measures.

A statistical analysis plan was approved by the study statistician (SH) and chief investigator (CS) before data analysis, and no changes were made after this time (see S3 Text). Analysis was conducted by 2 investigators (CS, LH) blinded to group allocation for the co-primary outcomes using dummy codes for group allocation, created by a person external to the trial. The dataset analysed consisted of all randomised participants irrespective of intervention adherence (intention-to-treat). Missing values were not imputed for the primary analyses. Between-group comparisons for continuously scored outcomes were made using linear models with baseline scores entered as covariates. The distribution of continuous variables was evaluated to inform whether change scores were used for analysis. Fall rates between groups were compared using negative binomial regression. Two pre-specified sensitivity analyses were conducted for the co-primary outcomes; (i) not adjusting for baseline scores and (ii) adjusting for stratification variables. p-Values were not adjusted for multiplicity as we pre-specified that a significant effect must be observed on both primary outcomes to declare the intervention effective.

We undertook 6 pre-specified subgroup analyses based on neurological versus non-neurological health conditions limiting mobility, sex, age, baseline mobility (SPPB total score), device use before hospitalisation, and state (New South Wales versus South Australia). The main analysis for each subgroup analysis was an interaction test in the regression models to determine whether the effect of treatment differed significantly across categories for that variable. Analyses were performed using Stata software, version 14 (StataCorp).

IRB approval

Two human research ethics committees (HRECs) approved the trial (Southern Adelaide Clinical HREC and South Western Sydney Local Health District HREC). Six minor protocol amendments were approved by the ethics committees, 4 prior to the trial commencing (see S2 Text). We prospectively registered the trial with the Australian New Zealand Clinical Trials Registry (ACTRN12614000936628).

Results

Between September 2014 and November 2016, 5,039 patients were screened, 715 patients were assessed as eligible, and 300 patients provided written informed consent and were randomised: 149 to the intervention group and 151 to the control group (Fig 1). Six-month assessments were completed by 258 participants (control group: 129/151, 85%; intervention group: 129/149, 87%). For the co-primary outcomes, there was an 85% (254/300) follow-up rate for mobility (data unavailable for 4 additional participants who refused to complete 1 or more test components) and an 80% (239/300) follow-up rate for upright time (data missing or excluded for 19 additional participants due to <4 days wear time for activPAL device, n = 3; refusal/unable to wear device, n = 5; device initialisation/fault, n = 3; device lost, n = 4; missing data, n = 4).

Fig 1

CONSORT flow diagram.

*Number included in intention-to-treat analysis. LOS, length of stay.

Baseline characteristics are presented in Tables 2 and S1. On average, participants spent 13 days in the ward before randomisation (SD 16; median 8). Participants had a mean age of 74 (SD 14) years, 50% were female, and 54% had neurological health conditions causing activity limitation. At baseline, participants had significant mobility limitation (mean [SD] SPPB total score 4.2 [2.6]) and spent little time standing or stepping (mean [SD] upright time 112 [90] minutes) (Table 3). Prior to hospital admission, 87% of participants could walk independently in the community and all but 1 could walk indoors. Thirty-nine percent of participants reported never using a computer, tablet, smartphone, gaming device, or activity monitor in the month prior to hospitalisation.

Table 2

Characteristics of participants at baseline.

Characteristic	Intervention groupn = 149	Control groupn = 151
Demographics
Age (years), mean (SD); range	70 (18); 18–101	73 (15); 21–95
<50, n (%)	21 (14)	15 (10)
50–69, n (%)	44 (30)	38 (25)
70–89, n (%)	73 (49)	85 (57)
90+, n (%)	11 (7)	13 (8)
Sex female, n (%)	72 (48)	77 (51)
Prior living arrangement, n (%)
Alone	58 (39)	46 (31)
Family	89 (60)	102 (68)
Non-relative	2 (1)	3 (1)
Marital status, n (%)
Currently married/cohabitating	70 (47)	77 (51)
Divorced/separated	23 (16)	14 (9)
Widowed	39 (26)	43 (29)
Never married	17 (11)	17 (11)
Years of education, mean (SD); range	12 (3); 5–20	12 (4); 4–32
0–12 years, n (%)	85 (57)	91 (60)
13–16 years, n (%)	39 (26)	36 (24)
>16 years, n (%)	15 (10)	17 (11)
Unknown, n (%)	10 (7)	7 (5)
Current work status, n (%)
Retired	91 (62)	95 (63)
Paid work	27 (18)	22 (15)
Homemaker	6 (4)	14 (9)
Unemployed	14 (9)	10 (7)
Student	5 (3)	2 (1)
Volunteer/other	6 (4)	8 (5)
English primary language at home, n (%)	129 (87)	129 (85)
Health
Neurological condition causing activity limitation, n (%)	80 (54)	82 (54)
Primary diagnosis grouping, n (%)
Neurological	72 (48)	77 (51)
Cardiopulmonary	16 (11)	9 (6)
Musculoskeletal	41 (28)	48 (32)
Restorative care/other	20 (13)	17 (11)
MMSE score (0–30), mean (SD); range	27 (3); 15–30	27 (3); 17–30
Number of co-morbidities (0–26), mean (SD); range	5 (3); 0–14	5 (3); 0–11
Number of medications at entry to study, mean (SD); range	8 (3); 1–19	9 (3); 2–17
Function
Walking status prior to hospitalisation, n (%)
Did not walk	0 (0)	1 (1)
Indoor walker only	17 (11)	20 (13)
Community walker	132 (89)	130 (86)
Devices
Devices used in month prior to hospitalisation, n (%)
Computer	60 (40)	63 (42)
Tablet	44 (30)	35 (23)
Smartphone	55 (37)	52 (34)
Gaming console	6 (4)	1 (1)
Activity monitor	7 (5)	2 (1)

MMSE, Mini-Mental State Examination.

Table 3

Primary and secondary outcome measures at baseline, 3 weeks, 12 weeks, and 6 months.

Outcome	Mean (SD), n
	Intervention group				Control group
	Baseline	3 weeks	12 weeks	6 months	Baseline	3 weeks	12 weeks	6 months
Performance-based outcomes
Physical activity (activPAL)
Proportion of the day spent upright (%)	8.0 (6.7)	14.5 (8.4)		18.2 (9.8)	7.5 (5.7)	14.2 (8.6)		18.4 (10.2)
	n = 146	n = 135		n = 121	n = 151	n = 141		n = 124
Time spent upright (minutes/day)	115 (96)	208 (122)		262 (142)	109 (83)	204 (124)		265 (147)
	n = 146	n = 135		n = 121	n = 151	n = 141		n = 124
Time spent standing (minutes/day)	97 (91)	164 (105)		201 (121)	87 (74)	161 (104)		209 (122)
	n = 146	n = 135		n = 121	n = 151	n = 141		n = 124
Time spent stepping (minutes/day)	19 (17)	44 (30)		61 (40)	21 (23)	43 (33)		56 (38)
	n = 146	n = 135		n = 121	n = 151	n = 141		n = 124
Number of steps per day	1,107 (1,101)	2,892 (2,144)		4,395 (3,129)	1,315 (1,754)	2,865 (2,590)		3,858 (2,951)
	n = 146	n = 135		n = 121	n = 151	n = 141		n = 124
Number of sit to stand transitions per day	36 (18)	42 (14)		43 (16)	38 (24)	43 (19)		41 (15)
	n = 146	n = 135		n = 121	n = 151	n = 141		n = 124
Mobility
Short Physical Performance Battery
Continuous (0–3)	1.5 (0.7)	2.1 (0.6)		2.3 (0.6)	1.5 (0.8)	1.8 (0.8)		2.1 (0.8)
	n = 149	n = 139		n = 126	n = 149	n = 141		n = 129
Total score (0–12)	4.3 (2.6)	6.7 (2.9)		7.9 (3.1)	4.2 (2.6)	5.8 (3.3)		7.0 (3.4)
	n = 149	n = 141		n = 128	n = 151	n = 143		n = 129
Balance subscale (0–4)	2.2 (1.5)	3.0 (1.3)		3.3 (1.1)	2.0 (1.4)	2.6 (1.4)		3.0 (1.3)
	n = 149	n = 141		n = 128	n = 151	n = 143		n = 129
Gait speed subscale (0–4)	1.6 (1.1)	2.5 (1.2)		2.9 (1.1)	1.6 (1.2)	2.2 (1.3)		2.7 (1.3)
	n = 149	n = 141		n = 128	n = 151	n = 143		n = 129
Chair stand subscale (0–4)	0.5 (0.8)	1.2 (1.3)		1.7 (1.5)	0.6 (1.0)	1.0 (1.2)		1.4 (1.3)
	n = 149	n = 141		n = 128	n = 151	n = 143		n = 129
de Morton Mobility Index (0–100)	45.3 (12.2)	58.9 (15.3)		67.4 (18.3)	44.3 (13.4)	54.2 (19.2)		64.4 (19.6)
	n = 149	n = 141		n = 128	n = 151	n = 143		n = 128
Single leg stance (0–10 seconds)	1.9 (3.3)	3.7 (4.1)		5.4 (4.3)	2.1 (3.3)	2.9 (3.8)		4.2 (4.2)
	n = 149	n = 141		n = 127	n = 151	n = 143		n = 129
Maximal balance range test (millimetres)	101.8 (63.0)	129.2 (64.5)		143.4 (76.8)	97.4 (61.7)	110.8 (69.6)		125.7 (67.1)
	n = 149	n = 141		n = 128	n = 151	n = 143		n = 129
Step test (steps, average of both legs)	4.2 (4.9)	7.7 (5.4)		10.1 (5.9)	4.0 (5.0)	6.0 (5.8)		8.2 (6.1)
	n = 149	n = 141		n = 128	n = 151	n = 143		n = 129
Cognition†
Trail Making Test A (0–120 seconds)	59.3 (29.5)	45.6 (21.7)		43.3 (22.5)	62.4 (31.7)	51.3 (27.7)		45.1 (22.9)
	n = 149	n = 141		n = 128	n = 151	n = 142		n = 127
Trail Making Test B (0–300 seconds)	165.6 (91.8)	121.6 (73.1)		107.7 (69.4)	173.7 (90.8)	127.3 (78.7)		110.4 (62.1)
	n = 149	n = 141		n = 128	n = 151	n = 142		n = 126
Trail Making Test B minus A (seconds)	106.3 (74.5)	75.9 (58.8)		64.5 (51.8)	111.3 (71.0)	76.1 (57.0)		65.9 (48.4)
	n = 149	n = 141		n = 128	n = 151	n = 142		n = 126
Participant-reported outcome measures
Incidental and Planned Exercise Questionnaire (hours/week)
Total score		20.9 (14.7)	23.0 (16.3)	27.0 (15.3)		19.2 (12.8)	21.9 (18.1)	24.6 (16.1)
		n = 140	n = 128	n = 128		n = 143	n = 127	n = 129
Home exercise subscale		1.6 (2.9)	1.5 (2.6)	1.8 (3.2)		1.9 (3.3)	1.5 (2.9)	1.3 (2.4)
		n = 140	n = 128	n = 128		n = 143	n = 127	n = 129
Walking activity subscale		2.7 (3.5)	3.3 (4.0)	4.8 (5.8)		1.7 (2.4)	2.3 (4.5)	2.7 (3.6)
		n = 140	n = 128	n = 128		n = 143	n = 127	n = 129
Modified Computer Self Efficacy Scale (10–100)	65.0 (22.1)	67.8 (26.8)	66.0 (27.8)	75.1 (24.3)	62.3 (23.6)	70.3 (24.9)	65.4 (26.4)	70.8 (26.1)
	n = 149	n = 141	n = 130	n = 129	n = 151	n = 143	n = 132	n = 127
Activities-specific Balance Confidence Scale (0–100)	39.6 (26.6)	51.7 (26.1)	57.3 (26.0)	66.5 (23.6)	36.3 (26.5)	49.7 (27.2)	55.3 (30.2)	62.4 (26.8)
	n = 148	n = 141	n = 129	n = 129	n = 151	n = 143	n = 132	n = 128
WHO Disability Assessment Schedule 2.0 (raw score 12–60)†		27.8 (7.8)	25.6 (8.5)	21.8 (7.4)		29.2 (8.2)	26.5 (9.7)	23.1 (8.6)
		n = 141	n = 131	n = 129		n = 143	n = 132	n = 128
Short Form 6 dimensions questionnaire
Physical function domain (1–6)	4.4 (1.1)	4.0 (0.9)	3.7 (1.0)	3.6 (1.1)	4.5 (1.1)	4.1 (0.9)	3.8 (1.2)	3.6 (1.2)
	n = 149	n = 141	n = 130	n = 129	n = 150	n = 143	n = 132	n = 129
Role limitation domain (1–4)	3.1 (1.1)	3.3 (1.0)	3.2 (1.1)	2.8 (1.1)	3.3 (1.0)	3.1 (1.0)	3.1 (1.1)	2.9 (1.2)
	n = 149	n = 141	n = 130	n = 129	n = 150	n = 143	n = 132	n = 129
Social functioning domain (1–5)	3.2 (1.6)	3.2 (1.4)	2.5 (1.3)	2.1 (1.3)	3.3 (1.6)	3.1 (1.6)	2.6 (1.5)	2.3 (1.5)
	n = 149	n = 141	n = 130	n = 129	n = 150	n = 142	n = 132	n = 128
Pain domain (1–6)	3.4 (1.8)	3.3 (1.7)	3.2 (1.6)	2.8 (1.4)	3.9 (1.6)	3.2 (1.6)	3.3 (1.5)	3.0 (1.5)
	n = 149	n = 141	n = 130	n = 129	n = 150	n = 143	n = 132	n = 129
Mental health domain (1–5)	2.6 (1.2)	2.4 (1.2)	2.3 (1.2)	2.2 (1.2)	2.6 (1.1)	2.6 (1.2)	2.5 (1.2)	2.3 (1.3)
	n = 149	n = 141	n = 130	n = 129	n = 150	n = 143	n = 132	n = 129
Vitality domain (1–5)	3.6 (1.3)	3.4 (1.1)	3.3 (1.1)	3.1 (1.0)	3.8 (1.2)	3.6 (1.2)	3.5 (1.1)	3.3 (1.1)
	n = 149	n = 141	n = 129	n = 129	n = 150	n = 143	n = 132	n = 129
Health utility (0–1)	0.28 (0.26)	0.32 (0.25)	0.38 (0.24)	0.45 (0.25)	0.22 (0.24)	0.30 (0.26)	0.35 (0.29)	0.42 (0.30)
	n = 149	n = 141	n = 129	n = 129	n = 150	n = 142	n = 132	n = 128
EuroQOL-5L
Mobility domain (1–5)	3.0 (1.0)	2.3 (1.0)	2.3 (1.0)	2.0 (1.0)	2.9 (1.1)	2.4 (1.1)	2.5 (1.1)	2.2 (1.0)
	n = 149	n = 141	n = 130	n = 129	n = 151	n = 143	n = 132	n = 129
Selfcare domain (1–5)	2.4 (1.2)	1.8 (1.0)	1.7 (0.9)	1.5 (0.9)	2.5 (1.1)	2.0 (1.0)	1.8 (1.1)	1.7 (1.1)
	n = 149	n = 141	n = 130	n = 129	n = 151	n = 143	n = 132	n = 129
Usual activities domain (1–5)	3.2 (1.4)	2.7 (1.2)	2.4 (1.2)	1.9 (0.9)	3.5 (1.3)	2.8 (1.3)	2.6 (1.3)	2.1 (1.2)
	n = 149	n = 140	n = 130	n = 129	n = 151	n = 143	n = 132	n = 129
Pain or discomfort domain (1–5)	2.4 (1.1)	2.0 (1.0)	2.2 (1.1)	2.0 (0.9)	2.6 (1.1)	2.2 (1.1)	2.3 (1.0)	2.1 (1.0)
	n = 149	n = 141	n = 129	n = 129	n = 151	n = 143	n = 132	n = 129
Anxiety or depression domain (1–5)	1.8 (1.0)	1.6 (0.9)	1.7 (0.9)	1.6 (0.9)	1.8 (0.9)	1.7 (0.9)	1.8 (1.0)	1.6 (0.8)
	n = 149	n = 141	n = 130	n = 129	n = 151	n = 143)	n = 132	n = 129
VAS score (0–100)	54.5 (21.9)	65.7 (18.3)	66.9 (20.8)	71.5 (18.3)	55.0 (20.7)	64.3 (22.1)	67.2 (20.3)	70.2 (20.7)
	n = 149	n = 141	n = 130	n = 129	n = 151	n = 143	n = 132	n = 129
Health utility score (−0.68 to 1)	0.40 (0.36)	0.60 (0.27)	0.58 (0.29)	0.70 (0.25)	0.36 (0.29)	0.54 (0.31)	0.52 (0.35)	0.65 (0.29)
	n = 149	n = 140	n = 129	n = 129	n = 151	n = 143	n = 132	n = 129
System Usability Scale (0–100)		72.2 (18.7)	74.2 (19.8)	78.0 (17.4)
		n = 134	n = 123	n = 127
Physical Activity Enjoyment Scale (18–126)		95.5 (23.2)	95.7 (22.0)	98.3 (20.8)
		n = 133	n = 122	n = 127

†A lower score indicates a better performance.

EuroQOL-5L, European Quality of Life–5; VAS, visual analogue scale.

Intervention fidelity, acceptability, enjoyment, and adherence

Over the 6-month trial period, participants spent on average 19 days (SD 20; median 12) in an inpatient setting and 161 days (SD 18) in a post-hospital setting, typically at home. The total cost of the intervention (staff training, equipment, intervention preparation, and delivery) per participant was AU$1,892 (S2 Table). Intervention data are presented in Table 4. Intervention participants rated the usability of prescribed devices above average, and enjoyment as high at all time points (Table 3).

Table 4

Intervention group data.

Characteristic	Mean (SD), percent, or n (%)
Inpatient (n = 149)
Dose
Number sessions offered	11 (16)#
Number sessions delivered	7 (10)#
Duration of sessions, minutes	41 (11)
Reasons for sessions not delivered
Day of discharge	18%
Feeling tired/unwell	16%
Refusal	11%
Unknown	11%
Public holiday	10%
Devices used
Number of devices	4 (1)
Nintendo Wii	36 (24%)
Xbox Kinect	39 (26%)
Activity monitor (Fitbit, Garmin)	120 (81%)
Smartphone physical activity app	3 (2%)
Fysiogaming	85 (57%)
iPad exercise app	107 (72%)
Humac Balance System	89 (60%)
Stepping Tiles	46 (31%)
Mobility limitations addressed using devices
Maintaining standing position	120 (81%)
Stepping while standing	119 (80%)
Standing up from a chair	114 (77%)
Reaching while standing	67 (45%)
Changing directions while walking	56 (38%)
Stair climbing	25 (17%)
Physical activity through the day	135 (91%)
Community (n = 144)
Dose
Number contacts with physiotherapist	15 (5)
Home visit frequency	6 (1)
Home visit duration, minutes	46 (13)
Phone call frequency	8 (4)
Phone call duration, minutes	8 (3)
Other* frequency	1 (1)
Other* duration, minutes	6 (20)
Reason for physiotherapist contact
Health coaching	68%
Quick contact	20%
Device support	8%
Other	4%
Devices used
Number of devices	2 (1)
Nintendo Wii	23 (16%)
Xbox Kinect	24 (17%)
Activity monitor (Fitbit, Garmin)	141 (98%)
Smartphone physical activity app	8 (6%)
Fysiogaming (home version)	5 (3%)
iPad exercise app	124 (86%)
Topics covered in health coaching sessions (n = 1,419 sessions)
Objective data from devices	1128 (80%)
Physical activity status	999 (70%)
Mobility status	994 (70%)
Adherence (barriers and facilitators)	909 (64%)
Goal setting and evaluation	662 (47%)
Technical issues and assistance	537 (38%)
Modification of exercise program	495 (35%)
Physical activity/health education	296 (21%)
Fall prevention and education	225 (16%)
Other	210 (15%)
6-month physiotherapist-rated level of adherence
>75%	45 (30%)
50–74%	37 (25%)
25–49%	30 (25%)
1–24%	25 (17%)
0%	7 (5%)
Not rated	5 (3%)

#Median (IQR) values.

*Other: email, video conference, SMS, hospital visit.

Participants in both groups received a similar number of usual care physiotherapy sessions in the post-hospital setting (mean [SD]: intervention group, 10 [15]; control group, 10 [13] sessions). Few control participants reported using devices for mobility or physical activity (inpatient setting: computer, n = 1; tablet, n = 2; activity monitor, n = 3; post-hospital setting: smartphone, n = 1; gaming device, n = 2; activity monitor, n = 9 participants).

Effect of intervention

Co-primary outcomes

Change in mobility scores were higher in the intervention group compared to the control group from baseline (SPPB [continuous, 0–3] mean [SD]: intervention group, 1.5 [0.7]; control group, 1.5 [0.8]) to 6 months (mean between-group difference 0.2 points, 95% CI 0.1 to 0.3; p = 0.006); however, there was no evidence of a difference between groups for upright time at 6 months (mean [SD] proportion of the day spent upright at 6 months: intervention group, 18.2 [9.8]; control group, 18.4 [10.2]; mean between-group difference −0.2, 95% CI −2.7 to 2.3; p = 0.87), with similar results in sensitivity analyses (S3 Table) and at week 3 (Table 5).

Table 5

Primary and secondary performance-based outcomes.

Outcome	Time point or time between assessments	Mean between-group difference (95% CI) in outcome, adjusted for baseline; n	p-Value
Co-primary outcomes
Mobility (positive MD favours intervention group)
SPPB (continuous version, 0–3)	6 mo minus baseline	0.2 (0.1 to 0.3); 254&,§	0.006
Physical activity (positive MD favours intervention group)
Proportion of the day spent upright (%)	At 6 mo	−0.2 (−2.7 to 2.3); 239§	0.87
Secondary outcomes
Mobility (positive MD favours intervention group)
SPPB
Continuous version (0–3)	3 wk minus baseline	0.3 (0.1 to 0.4); 279&	<0.001
Total score (0–12)	3 wk minus baseline	0.9 (0.3 to 1.5); 284¶,&	0.002
	6 mo minus baseline	0.9 (0.2 to 1.6); 257¶,#,*,§	0.01
Balance subscale score (0–4)~	3 wk minus baseline	1.9 (1.2 to 3.1); 284	0.007
	6 mo minus baseline	1.9 (1.1 to 3.1); 257	0.02
Gait speed subscale score (0–4)~	3 wk minus baseline	1.5 (1.0 to 2.3); 284	0.07
	6 mo minus baseline	1.4 (0.9 to 2.3); 257	0.13
Chair stand subscale score (0–4)~	3 wk minus baseline	1.9 (1.2 to 3.0); 284	0.006
	6 mo minus baseline	1.6 (1.0 to 2.5); 257	0.04
de Morton Mobility Index (0–100)	3 wk minus baseline	4.0 (0.8 to 7.2); 284&	0.02
	6 mo minus baseline	2.8 (−1.2 to 6.9); 256‡	0.17
Single leg stance (0–10 seconds)	3 wk minus baseline	0.9 (0.1 to 1.8); 284	0.03
	6 mo minus baseline	1.2 (0.2 to 2.2); 256§	0.02
Maximal balance range test (millimetres)	3 wk minus baseline	16.8 (3.2 to 30.4); 284&	0.02
	6 mo minus baseline	17.5 (1.6 to 33.4); 257	0.03
Step test (steps, average of both legs)	3 wk minus baseline	1.7 (0.6 to 2.7); 284¶,§	0.002
	6 mo minus baseline	2.0 (0.7 to 3.3); 257	0.003
Physical activity (positive MD favours intervention group)
Proportion of the day spent upright, percent	At 3wk	0.2 (−1.8 to 2.1); 271	0.86
Time spent upright (minutes/day)	At 3wk	2.4 (−25.3 to 30.2); 271	0.86
	At 6 mo	−3.1 (−39.4 to 33.2); 239§	0.87
Time spent standing (minutes/day)	3 wk minus baseline	0.7 (−23.1 to 24.5); 271	0.96
	6 mo minus baseline	−9.3 (−39.7 to 21.1); 239^	0.55
Time spent stepping (minutes/day)	3 wk minus baseline	3.2 (−3.1 to 9.6); 271	0.32
	6 mo minus baseline	6.4 (−3.3 to 16.2); 239#,§	0.19
Number of steps per day	3 wk minus baseline	238 (−223 to 699); 271^	0.31
	6 mo minus baseline	646 (−109 to 1,402); 239#,§	0.09
Number of sit to stand transitions per day	3 wk minus baseline	0 (−4 to 3); 271	0.88
	6 mo minus baseline	2 (−2 to 6); 239§	0.31
Cognition (negative MD favours intervention group)
Trail Making Test A (seconds)	3 wk minus baseline	−5.1 (−9.3 to −0.8); 283‡,^	0.02
	6 mo minus baseline	−1.3 (−6.6 to 4.0); 255‡	0.64
Trail Making Test B (seconds)	3 wk minus baseline	0.4 (−12.7 to 13.5); 283‡	0.95
	6 mo minus baseline	4.0 (−10.2 to 18.3); 254	0.58
Trail Making Test B − A (seconds)	3 wk minus baseline	1.7 (−8.7 to 12.0); 283‡	0.75
	6 mo minus baseline	0.1 (−10.3 to 10.5); 254¶	0.99

Unless otherwise indicated, analyses were conducted with linear regression models with baseline scores entered as covariates. Due to skewed distributions, the change score between time points was used for all outcomes except proportion of the day spent upright. Confidence intervals have not been adjusted for multiplicity, so inferences drawn from the intervals may not be reproducible. Between-group differences are presented as odds ratios. Footnotes indicate significant interactions (p ≤ 0.05) for the following pre-specified variables at the given time points:

#age as a continuous variable;

*age dichotomised at the median (76 years);

&baseline mobility as a continuous variable (SPPB total score);

^prior device use;

§state (New South Wales versus South Australia);

¶health condition (neurological versus non-neurological);

‡sex.

~Analyses conducted with ordered logistic regression for final scores, with baseline scores as a covariate.

MD, mean difference; SPPB, Short Physical Performance Battery.

There were between-group differences in favour of the intervention group across most secondary mobility outcomes (Table 5), for change in self-reported time spent walking from 3 weeks to 6 months (IPEQ walking activity subscale, hours/week: 1.8, 95% CI 0.6 to 3.0, n = 254; p = 0.004), and for change on 1 measure of cognition from baseline to 3 weeks (Trail Making Test A: −5.1 seconds, 95% CI −9.3 to −0.8, n = 283; p = 0.02). There was no evidence of a difference between groups in the number of steps taken per day from baseline to 6 months (mean between-group difference 646 steps per day, 95% CI −109 to 1,402, n = 239; p = 0.09) or on any other secondary outcomes (Tables 5 and 6 and S4). Thirteen participants died while in the trial (intervention group: 9; control group: 4) due to causes unrelated to the trial. The same number of participants reported falling 1 or more times in both groups (n = 53), and there was no difference between groups in fall rate (S5 Table). No adverse events, defined as incidents that occurred while participating in the intervention, were reported.

Table 6

Secondary participant-reported outcomes.

Outcome	Time point or time between assessments	Mean between-group difference (95% CI) in outcome, adjusted for baseline; n	p-Value
Incidental and Planned Exercise Questionnaire (positive MD favours intervention group)
Total score (h/wk)	12 wk minus 3 wk	0.4 (−3.7 to 4.4); 252	0.86
	6 mo minus 3 wk	1.9 (−1.7 to 5.6); 254	0.31
Home exercise subscale score (h/wk)	12 wk minus 3 wk	0.1 (−0.6 to 0.8); 252	0.79
	6 mo minus 3 wk	0.7 (−0.0 to 1.3); 254#	0.05
Walking activity subscale score (h/wk)	12 wk minus 3 wk	0.7 (−0.3 to 1.6); 252&	0.19
	6 mo minus 3 wk	1.8 (0.6 to 3.0); 254	0.004
Modified Computer Self Efficacy Scale (10–100) (positive MD favours intervention group)	3 wk minus baseline	−4.8 (−9.7 to 0.1); 284	0.06
	12 wk minus baseline	−1.1 (−6.8 to 4.5); 262	0.70
	6 mo minus baseline	2.2 (−3.3 to 7.7); 256‡	0.43
Activities-specific Balance Confidence Scale (0–100) (positive MD favours intervention group)	3 wk minus baseline	0.6 (−4.7 to 5.8); 283	0.83
	12 wk minus baseline	1.2 (−5.1 to 7.5); 260§	0.71
	6 mo minus baseline	4.0 (−1.7 to 9.8); 256	0.17
WHO Disability Assessment Schedule 2.0 (raw score 12–60) (negative MD favours intervention group)	12 wk minus 3 wk	−0.1 (−2.2 to 1.9); 261#,*,^,§	0.89
	6 mo minus 3 wk	−0.7 (−2.5 to 1.1); 255‡,§	0.46
Short Form 6 dimensions questionnaire (health utility score 0–1) (positive MD favours intervention group)	3 wk	0.00 (−0.06 to 0.05); 282	0.99
	12 wk	0.01 (−0.05 to 0.08); 260§	0.67
	6 mo	0.01 (−0.06 to 0.07); 256‡,§	0.82
European Quality of Life–5 dimensions (health utility score −0.68 to 1) (positive MD favours intervention group)	3 wk minus baseline	0.04 (−0.02 to 0.10); 283	0.15
	12 wk minus baseline	0.05 (−0.02 to 0.13); 261#,*	0.16
	6 mo minus baseline	0.05 (−0.02 to 0.11); 258‡	0.14

This analysis was conducted using linear regression models with baseline scores entered as covariates. Due to skewed distributions, the change score between time points was used for all outcomes except the Short Form 6 dimensions questionnaire. Confidence intervals have not been adjusted for multiplicity, so inferences drawn from the intervals may not be reproducible.

Footnotes indicate significant interactions (p ≤ 0.05) for the following pre-specified variables at the given time points: #age as a continuous variable;

*age dichotomised at the median (76 years);

&baseline mobility as a continuous variable (SPPB total score);

^prior device use;

§state (New South Wales versus South Australia);

¶health condition (neurological versus non-neurological);

‡sex.

MD, mean difference; SPPB, Short Physical Performance Battery.

Interaction analysis for primary outcomes indicated a greater effect of the intervention on mobility among those with poorer mobility at baseline (Tables 5 and S6). Exploratory analyses for secondary outcomes revealed consistently greater intervention impact in younger participants (Tables 5 and 6 and S7).

Discussion

We conducted a pragmatic, assessor-blinded, parallel-group randomised trial in people with mobility limitations undertaking aged care and neurological rehabilitation recruited from 3 Australian hospitals to investigate whether tailored prescription of affordable digital devices (including virtual reality video games, activity monitors, and handheld computer devices) in addition to usual care could improve mobility and physical activity when compared with people undertaking usual care alone. There was no evidence of effectiveness of the intervention in accordance with our pre-specified definition that both primary outcomes needed to show statistically significant between-group differences. However, significant and clinically relevant improvements in mobility were observed in participants receiving the AMOUNT intervention. The greatest improvements in mobility were seen at 3 weeks during hospital-supervised therapy. Between-group differences were still evident at 6 months despite the lower intensity physiotherapy support in the post-hospital period. All available devices were used, supporting our premise of a multi-device intervention over using a single device as in previous studies. Six of the devices were used across both inpatient and post-hospital care settings, and usability and enjoyment were rated highly. Taken altogether, these findings suggest that digitally enabled rehabilitation, supported by physiotherapists, is feasible and acceptable and can improve mobility outcomes.

The mean between-group difference on our primary mobility measure at 6 months (0.2 points) may be considered of clinical importance. A change of 0.54 on the 12-point version of the SPPB, i.e., 4.5% of the maximum value, has been suggested to be a small meaningful change [20]. The between-group difference at 6 months in the present study represents 6.7% of the maximum value for the 3-point version; therefore, it may represent meaningful change.

In the inpatient setting, participants received on average 41 minutes daily of additional rehabilitation using devices (Table 4). Approximately 60% of participants used the rehabilitation video games (Fysiogaming and the Humac Balance System), which enable the greatest customisation of task-specific mobility training. Our findings of improved mobility are consistent with previous systematic reviews demonstrating improved activity when a greater amount of task-specific practice is provided [4,5]. In contrast, our findings of improved mobility are different than those of the Cochrane systematic review of virtual reality interventions in people after stroke for the effect of additional virtual reality intervention on global motor function [11]. This is likely due to our multi-device intervention and detailed intervention protocol, enabling additional task-specific practice of a range of mobility tasks, compared to the lower limb trials in the review using 1 device, typically targeting balance. The range of health conditions and inclusion of younger participants in our trial may also explain the different findings; however, participants with neurological health conditions and participants with worse mobility at baseline had the greatest improvements in mobility (SPPB total score), particularly at 3 weeks. It is difficult to tease out the contributing role of both amount and type of practice; however, our results suggest that attention to quality and quantity of rehabilitation practice is important.

Although the physical capacity of participants in the intervention group to move around improved, this did not translate to increased time spent upright. Yet there was an indication of more steps taken by intervention participants (p = 0.09; particularly younger participants, <76 years, p = 0.05), greater self-reported walking, and more time spent stepping and less time spent standing compared to control participants. This finding matches the way the intervention was delivered, with a focus on increasing the number of steps per day using a Fitbit tracker, rather than on standing activities. Further exploration of trial activPAL data is underway to better understand our findings and to help determine how best to prescribe physical activity in this population.

The success of the intervention in improving mobility is likely due to the personalisation of the intervention, which targeted each person’s mobility limitations. The included devices were piloted previously [13], tested by consumer and clinician investigators, and prescribed according to a detailed protocol developed by the investigator team using motor learning principles [40]. The right level of challenge, variety, enjoyment, and support to use the devices appears key to successful participant engagement [14,41].

Study limitations include 15%–19% loss to follow-up at 6 months on co-primary outcomes, as anticipated in this age group of hospitalised patients. Multiplicity is also a consideration due to the number of outcomes measured. Additionally, there was no statistically significant difference in the important participant-reported outcome of health-related quality of life; however, the measures of this outcome were in the direction favouring the intervention group, which may reflect low statistical power to demonstrate significance for this outcome. There was greater time spent with therapists in the intervention group, which could account for the difference between groups. However, as this was a pragmatic trial, we consider our choice of usual care and an enhanced program to be the correct comparison, and our trial found additional benefits of the enhanced program. Contamination was of concern prior to commencing the study; however, only a small number of control participants reported using devices for mobility or physical activity. Although the range of devices was a strength, accurate documentation of dosage was difficult because of differences in the types of output data (e.g., game time, repetitions), particularly at home. Development and testing of efficient solutions such as clinical dashboards that enable data from diverse sources to be integrated into a common platform [42] may facilitate tailored use and monitoring of multiple devices in rehabilitation.

Further research should investigate whether future models of rehabilitation care can incorporate digital devices to enhance inpatient and post-hospital rehabilitation with a higher dose of practice whilst conserving quality. Hybrid type II effectiveness–implementation study designs [43] could be used to simultaneously test the effectiveness of the clinical intervention (digitally enabled rehabilitation) on patient outcomes and the effectiveness of implementation strategies (e.g., education and training) to support clinicians to include digital devices into practice.

In summary, we observed improved mobility in participants with a wide range of health conditions in a digitally enabled rehabilitation environment, but no between-group differences in upright time. To enhance generalisability, we focussed on devices likely to be affordable for most rehabilitation services, with elements that could transfer into the community when the patient is discharged. Nevertheless, this was a complex intervention, with specialised equipment and expert staff, so further analyses including economic analysis will be important in understanding its acceptability to purchasers and providers of healthcare.

(DOCX)

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Participant primary diagnosis at rehabilitation admission.

(DOCX)

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Costs for digitally enabled rehabilitation intervention.

(DOCX)

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Sensitivity analyses for primary outcomes.

(DOCX)

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Primary and secondary outcomes (additional analysis).

(DOCX)

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Fall outcomes at 26 weeks.

(DOCX)

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Interaction p-values for co-primary outcomes and mean between-group difference (95% CI) for significant (p ≤ 0.05) interaction terms.

(DOCX)

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Interaction p-values for secondary outcomes and mean-between group difference (95% CI) for significant interaction terms.

(DOCX)

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Intervention protocol.

(DOCX)

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AMOUNT rehabilitation trial: Study protocol and intervention protocol amendments.

(DOC)

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Statistical analysis plan.

(DOCX)

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8 Oct 2019

Dear Dr. Hassett,

Thank you very much for submitting your manuscript "Digitally-enabled rehabilitation to enhance outcomes: The Activity and MObility UsiNg Technology (AMOUNT) randomised controlled trial." (PMEDICINE-D-19-02056) for consideration at PLOS Medicine.

Your paper was evaluated by a senior editor and discussed among all the editors here. It was also discussed with an academic editor with relevant expertise, and sent to three independent reviewers, including a statistical reviewer. The reviews are appended at the bottom of this email and any accompanying reviewer attachments can be seen via the link below:

[LINK]

In light of these reviews, I am afraid that we will not be able to accept the manuscript for publication in the journal in its current form, but we would like to consider a revised version that addresses the reviewers' and editors' comments. Obviously we cannot make any decision about publication until we have seen the revised manuscript and your response, and we plan to seek re-review by one or more of the reviewers.

In revising the manuscript for further consideration, your revisions should address the specific points made by each reviewer and the editors. Please also check the guidelines for revised papers at http://journals.plos.org/plosmedicine/s/revising-your-manuscript for any that apply to your paper. In your rebuttal letter you should indicate your response to the reviewers' and editors' comments, the changes you have made in the manuscript, and include either an excerpt of the revised text or the location (eg: page and line number) where each change can be found. Please submit a clean version of the paper as the main article file; a version with changes marked should be uploaded as a marked up manuscript.

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2- The title could be a bit more descriptive, specifying the type of rehabilitation.

3- Please combine Methods and Findings sections of Abstract into one section, “Methods and Findings”.

4- Around line 105, please include a new sentence summarizing the secondary outcome findings (from lines 315-328); and a second new sentence summarizing the situation with adverse events, falls and deaths.

5- Please edit your language to be a bit more measureda, e.g. at line 108 "In this study, we observed improved mobility in people with a wide range of health conditions making use of digitally-enabled rehabilitation, whereas time spent upright was unchanged."

6- In the Methods section, please specify if written or verbal consent was obtained from the study participants, or if the ethics committee waived this requirement.

7- Lines 259-261(“Role of the Funding source”) can be removed.

8- Please briefly describe intervention and trial at beginning of the Discussion.

9- Line 355, please rephrase as "In this study, significant and clinically relevant improvements in mobility were observed in participants receiving the AMOUNT intervention ..." or similar.

10- At line 391, "we improved" seems too strong, please temper.

11- At line 424, please rephrase to "... we observed improved mobility in participants in a digitally-enabled rehabilitation environment ...".

Comments from the reviewers:

Reviewer #1: Thank you for the opportunity to review this very interesting RCT evaluating a complex intervention. The authors have conducted a pragmatic trial to evaluate whether digital-enabled rehabilitation can improve mobility and upright time in patients admitted to age and neurological care in hospital settings. Over a six month period, the intervention improved mobility but not upright time. Overall, the analyses were appropriate and followed the pre-specified statistical analyses plan. My comments are specified below:

1) Lines 190-191: Primary outcomes on SPPB - it's not clear why the commonly used 12-point score was not utilised as the primary outcome compared to the 0-3 score. I would think that a 12-point scale would have more variation to allow for movement in the outcome and hence may be able to detect larger changes. The analyses shows this as both the 0-3 score and 12-point score do show significant differences between groups with the different larger in the 12-point score.

2) Lines 195-198: Primary outcome on activPal - This outcome has been averaged across a 7-day period. I would expect that the daily monitoring would have some large variations relatively which doesn't not necessarily follow a normal distribution. It's also likely reason why it's an average across seven days is not going to capture the variation in the differences between groups.

3) Outcomes section in methods: The co-primary outcomes although stated in the abstract and findings are described as a mean difference between groups, there is some nuance between the mobility outcome and upright time outcome which could help with better clarity in the methods. The mobility outcome (SPPB) is a mean difference of the relative change from baseline (i.e. difference in difference) between groups whereas the activPAL was only the mean difference between groups at a point prevalence at six months.

4) Related to point 3) as the tables clearly show that activPAL was also assessed at baseline, did the authors look at the different in the mean difference between groups relative to baseline similar to the method used in analysing SPPB.

5) The outcome of the upright time has been averaged across a 7-day period for daily time. Was the daily activity time relatively stable as within each individual - as I would expect there is probably some variation which doesn't not necessarily follow a normal distribution? It may be also the reason that the average doesn't capture the nature of the change in this outcome. On suggestion could be look at this as a repeated measure analyses of average per-day between intervention and control groups.

6) Lines 226-227: It's not clear if falls and health community service usage were also part of adverse events monitored.

7) Lines 246-247: this needs justification using a NBR rather than a Poisson regression. I can venture a guess that a negative binomial model is expected to provide an improved fit to the data and accounted better for over-dispersion (variance is high compared to mean rates) than the Poisson regression model, but authors to clarify.

8) Consort diagram: I'm going to assume that the n = 129 included in the analysis on the consort was the number analysed for intention to treat - would be helpful to indicate this in the consort diagram with an * footnote

9) Table 2: It would be helpful to see in this baseline characteristics table whether any of the baseline factors were significantly different. There may be some slight variation between intervention and control just on quick view of the table (i.e. proportions for prior living arrangements, primary diagnosis grouping proportions. also intervention group looks like they are experience using devices in month prior to hospital). If some of these factors may be different - it could justify baseline covariate adjustment in the analysis of between group differences as if randomisation didn't completely control for confounding then these factors still may influence the results.

My overall impression is that this is a well-conducted, interesting, and important piece of work that warrant publication. The authors have stated that the economic analyses will be presented as a separate piece but I would encourage the authors to consider including the cost-effectiveness alongside this RCT as it would help with understanding the value for money of this intervention which would greatly enhance this piece. I see that as a key strength but ultimately up the authors. I hope the authors find the comments useful to help improve their hard work prior to publication.

Reviewer #2: It was a pleasure to review this well conducted trial evaluating an important clinical intervention, namely the use of digital technology to enhance rehabilitation across the ward and post-discharge settings. The inclusion of the intervention protocol and quality of intervention reporting in the manuscript is commendable. Overall the manuscript is well-written but I have outlined a number of areas that could be addressed to improve precision in the trial reporting. I would encourage revision of the manuscript and I hope my comments are useful to the authors in their endeavours to report this clinically relevant trial.

ABSTRACT

It would be useful to briefly explain what usual care is to provide context

The intervention would benefit from some more specific information as it was more involved than just prescribing devices.

CONSORT guidance for trial abstracts recommends specifying how participants were allocated to the interventions, further detail would be beneficial

Suggest adding 'outcome' before 'assessor-blinded' to aid clarity.

More information on the eligibility criteria is needed to understand which patient groups this trial would have implications for.

Results

Results for each group are needed with the mean-difference and Cis.

Suggest alternative wording is used for the results, 'significantly' can be ambiguous - statistically or clinically significant, or both? Suggest 'SPPB scores were higher in the intervention group compared to the control group' (or other wording to that effect).

Rather than 'similar between groups', suggest more precise statistical wording such as 'no evidence of a difference between groups' (or other wording to that effect)

Harms need to be reported, in line with CONSORT.

Suggest removing 'not unexpected in this group of hospitalised patients' as this is more a discussion point.

Conclusion - Were the improvements in SPPB clinically important?

Trial registration number is accurate and consistent with the submitted report

MAIN PAPER

Introduction

114-15: References to support this more general statement relate to stroke, whereas the preceeding sentence suggests this statement is about 'neurological and musculoskeletal health conditions'. References need revisiting or the statement made more precisely.

117-8: what is the hypothesised mechanism by which a digitally enhanced environment enables more practice? Behaviour change? What is the evidence for this mechanism?

126 - sentence tense correction needed 'requires' to 'required'

123-5 - which population was the feasibility assessed in and why this group(s)?

137 - it can be appreciated that the full economic evaluation may be reported later but the cost of delivery would be useful information to present with the main trial results to provide greater context. Not essential but would enhance the report.

146 - what was the trial training? What steps were taken to ensure selection bias was managed (any external audit/screening)?

149-50 - 'clinician assessed capacity for improvement' - how was this assessed? It appears possible that more complex patients could have been systematically excluded? It would be good to report all of the categories for eligibility in the CONSORT rather that the few selected to assess which of these criteria dominated (if any)

155 - what is the definition of a 'high care residential facility' (this is country specific so would be useful context)

165 - The Authors are commended for the reporting of the intervention. Suggest the description of usual care would be useful in the main text in a summary sentence, and a signpost to Table 1, before going onto the intervention.

172 - expand on 'contextual factors'

How did the interventions and protocol ensure sufficient dose and task-specificity? Some information is in the Table 1 and other files but this is important in the main text as it is difficult to interpret the main text independently.

181 - what was the justification for these co-primary outcomes?

192-93 - it is not clear why a different version of the SPPB was selected. The reference cited (Onder) does not seem to explicitly provide strong evidence that supports using this alternative calculation to the otherwise established version - please can the authors expand on this?

227-8 - how were adverse events reported? There is some information in the protocol on definitions but are these self-reported or clinician reported, or both? Differences in levels in clinical contact can influence this event reporting.

236 - why was a 15% between group difference in both measures specified? What were the underlying assumptions on clinically important differences in effects?

Sample size: It is not clear how the presence of co-primary outcomes was accounted for in the sample size calculation. With co-primary outcomes it is usually assumed that both endpoints need to demonstrate meaningful differences, which reduces power and increases type 2 error. If the sample sizes were calculated separately at 90% power, this would in effectively be 81% power over the two outcomes (0.9 x 0.9 = 0.81). This is likely to be less of an issue as the two endpoints are likely correlated but this section would benefit from further detail, for example, was there any sample size inflation to manage this? I could not find this detail in the protocol, registration, SAP or published protocol.

244 - 'intention to treat' - has this trial used a modified ITT? It looks like it was not a strict ITT as not all participants were included in the final analysis regardless withdrawals or lost to follow-up, please confirm.

247 - please specify of the sensitivity analyses were pre-specified

Were there any protocol amendments? If so, these should be included in the report in line with CONSORT

Much greater detail is needed on the strategies to blind assessors, how were the outcome measures assessed, what safeguards were there?

Results

271/Fig 1 - see earlier comments regarding adding detail to CONSORT on reasons; does the number analysed reflect both primary analyses?

'n=' missing on deceased

Very low loss to follow-up, excellent - were there any reasons for the withdrawals?

Results - for all percentages, it is informative to provide numerators and denominators

Table 2 and S1 - balanced baseline characteristics on a whole but note considerable variation in primary condition and age in the trial cohort is evident

302-3 - was there any skew in the number of sessions? Often the case in rehab trials where median, IQR, range is needed - would be reassuring to confirm during review

309 -14 - as per abstract - please see comments on reporting 'significant'

Table 5 - footnote states skew was managed - please add to methods section

325 - secondary outcomes section - with the risk of multiplicity, suggest the focus on evidence and avoiding interpretations, such as 'substantial but not statistically significant'. A focus in the results (effect estimate and measure of uncertainty) would strengthen this section.

349 - an interaction analysis is reported - was this the planned subgroup analyses.

350-2 - there are exploratory analyses presented - the details need to be added to the methods - if post hoc, these need to be justified - could these be reported in another report so that this report focuses on the main trial analyses and outcomes?

Discussion:

Lines 355 to 358 - as a co-primary outcome was used, should the interpretation start with confirmation that there was no evidence of effectiveness of the intervention? The separate outcomes could then be discussed.

There is a tendency to focus on the significant results/timepoints. Suggest that the statistically significant results should be interpreted with caution as the results section highlights that there were limited differences across most outcomes and timepoints (and the issues with multiplicity - see below).

Limitations:

-multiplicity is a consideration

-the great deal of heterogeneity in the devices being tested and in the baseline characteristics of participants included is mentioned but I think the discussion would be enhanced with more discussion around these issues and their implications

Reviewer #3: Thanks for the opportunity to read your paper. The study is relevant and interesting; the text is concise, methods and results clearly described. I look forward to reading the economic analysis also.

I have only two items for clarification:

1. Line 441 noted that greater time was spent with therapists in the intervention group than the control group.

Where are the data are that shows how much additional physiotherapy contact time the intervention group received, in comparison to the control group?

2. Re: Line 355 - the first discussion point regarding …clinically important improvements in …self-reported time spent walking…not accompanied by changes in upright time

Can you comment on the apparent discrepancy between self-reported time spent walking and instrumented (ActivPAL) time spent upright? Also, the comparison between instrumented time stepping and self-reported walking times?

e.g. Week 3: Instrumented time stepping = 44 min/day; instrumented time upright 208 min/day; IPEQ walking = 23 min/day (2.7 hrs/week)

I would expect self-reported walking and instrumented stepping times to be similar, and upright time (assuming this is standing and walking) to be a lot less.

Any attachments provided with reviews can be seen via the following link:

[LINK]

29 Oct 2019

Submitted filename: Response to Reviewers.doc

Click here for additional data file.

29 Nov 2019

Dear Dr. Hassett,

Thank you very much for re-submitting your manuscript "Digitally-enabled aged care and neurological rehabilitation to enhance outcomes: The Activity and MObility UsiNg Technology (AMOUNT) randomised controlled trial." (PMEDICINE-D-19-02056R1) for review by PLOS Medicine.

I have discussed the paper with my colleagues and the academic editor and it was also seen again by xxx reviewers. I am pleased to say that provided the remaining editorial and production issues are dealt with we are planning to accept the paper for publication in the journal.

The remaining issues that need to be addressed are listed at the end of this email. Any accompanying reviewer attachments can be seen via the link below. Please take these into account before resubmitting your manuscript:

[LINK]

Our publications team (plosmedicine@plos.org) will be in touch shortly about the production requirements for your paper, and the link and deadline for resubmission. DO NOT RESUBMIT BEFORE YOU'VE RECEIVED THE PRODUCTION REQUIREMENTS.

***Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out.***

In revising the manuscript for further consideration here, please ensure you address the specific points made by each reviewer and the editors. In your rebuttal letter you should indicate your response to the reviewers' and editors' comments and the changes you have made in the manuscript. Please submit a clean version of the paper as the main article file. A version with changes marked must also be uploaded as a marked up manuscript file.

Please also check the guidelines for revised papers at http://journals.plos.org/plosmedicine/s/revising-your-manuscript for any that apply to your paper. If you haven't already, we ask that you provide a short, non-technical Author Summary of your research to make findings accessible to a wide audience that includes both scientists and non-scientists. The Author Summary should immediately follow the Abstract in your revised manuscript. This text is subject to editorial change and should be distinct from the scientific abstract.

We expect to receive your revised manuscript within 1 week. Please email us (plosmedicine@plos.org) if you have any questions or concerns.

We ask every co-author listed on the manuscript to fill in a contributing author statement. If any of the co-authors have not filled in the statement, we will remind them to do so when the paper is revised. If all statements are not completed in a timely fashion this could hold up the re-review process. Should there be a problem getting one of your co-authors to fill in a statement we will be in contact. YOU MUST NOT ADD OR REMOVE AUTHORS UNLESS YOU HAVE ALERTED THE EDITOR HANDLING THE MANUSCRIPT TO THE CHANGE AND THEY SPECIFICALLY HAVE AGREED TO IT.

Please ensure that the paper adheres to the PLOS Data Availability Policy (see http://journals.plos.org/plosmedicine/s/data-availability), which requires that all data underlying the study's findings be provided in a repository or as Supporting Information. For data residing with a third party, authors are required to provide instructions with contact information for obtaining the data. PLOS journals do not allow statements supported by "data not shown" or "unpublished results." For such statements, authors must provide supporting data or cite public sources that include it.

If you have any questions in the meantime, please contact me or the journal staff on plosmedicine@plos.org.

We look forward to receiving the revised manuscript by Dec 06 2019 11:59PM.

Sincerely,

Louise Gaynor-Brook, MBBS PhD

Associate Editor

PLOS Medicine

plosmedicine.org

------------------------------------------------------------

Requests from Editors:

We note the referees comments on inclusion of a cost effectiveness analysis. Having considered and discussed with my colleagues, we feel that inclusion of information on cost evaluation would strengthen the case for publication in PLOS Medicine and we request its addition to the manuscript.

Data Availability: We will require clarification on data availability before publication. If the lead ethics committee do not permit distribution of de-identified data, we will require details for a point of contact (not an author) or a URL where researchers who meet requirements can apply to access the data. We will be unable to proceed with publication until our data requirements are met.

Title: Please revise your title according to PLOS Medicine's style. It should begin with main concept if possible, followed by the study design in the subtitle (ie, after a colon). We suggest ‘Digitally-enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial’

Please remove all information within the footer of each page

Lines 59-86 - Please remove all information presented here

Please be explicit within your Abstract Methods and Findings when recruitment to the RCT took place.

Please add to the Abstract Methods and Findings that the RCT was prospectively registered, providing the trial ID (rather than at the end of Abstract)

Please add summary demographic information for the participants of the study within your Abstract Methods and Findings

Line 93 - Please provide details on which cities the hospitals were in

Line 93 - Please provide details of the age range of adults recruited

Line 100 - Please add (SBBP) after the first mention of Short Physical Performance Battery

Line 111 - Please add a full stop after ‘...p=0·006)’ to break this up into 2 separate sentences

Line 116 - please give an example or two of what ‘other secondary outcomes’ were

Line 119 - Please add a sentence to your study limitations that ‘The large number of outcome assessments in our trial increases the risk of a type I error’ or similar. Please also comment on whether provision of the devices could be described as a limitation, relating to possible real-world applicability of the intervention.

Lines 144 & 178 - is there evidence to support that the intervention was enjoyable? If not, please remove.

Line 148 - please omit ‘(0.9 point between group difference on the Short Physical Performance Battery 0 to 12 scale)’ from your Author Summary

Line 175 - please revise to ‘A feasibility trial conducted by our team in people undertaking inpatient aged care and neurological rehabilitation (n=58)’

Line 179 - please omit ‘now’

Please provide dates for recruitment (section beginning line 19) and randomisation (section beginning line 212)

Line 228 – Is the intervention protocol part of the prespecified protocol?

Line 232 – Who paid for the devices that cost $3700? In Table 1 it appears that devices were ‘loaned’; this should also be mentioned in the main text on first mention.

Table 1 & line 286 – For face-to-face sessions and the IPEQ, please provide the questionnaires / interview material (and any others used) as supplementary files.

Table 1 – Why were the modifications planned?

Line 312 – Please state modifications to the analysis plan (and why), and refer to the supplementary file in your methods section.

Line 340 - please clarify whether this was written informed consent

Table 3 - please provide definitions for all abbreviations used

Tables 5, 6, S2, S3, S5, S6 - When a p value is given, please specify the statistical test used to determine it.

Line 435 - Please revise this paragraph as ‘no evidence of effectiveness’ followed by ‘significant and clinically relevant improvements’ appears contradictory on first reading

At line 443, you mention that “six” of the devices were used across care settings, but it appears from table 4 that a mean of 2 devices were used across the two settings. Please revise the wording as appropriate.

Line 448 - Please provide justification for how results can be considered of clinical importance if ‘clinically important difference has not been established for this version of the SPPB’

Line 493 - Please revise the sentence ‘there was no statistically significant difference in important participant-reported outcomes such as health related quality of life; however, all these outcomes were favourable’ to clarify your findings / make explicit whether significant differences were seen or not

Please add a short section on the implications and next steps for research, clinical practice, and/or public policy between your limitations and conclusion summary

Please include paragraph numbers (instead of page numbers) in your CONSORT statement

Please remove files Manuscript under review_1 and Manuscript under review_2

Comments from Reviewers:

Reviewer #1: The authors have appropriately responded the all the reviewers comments. The re-review of the methods and reporting of the trial methods and results are much improved and clearer. This is a high quality trial, with well-reported findings, and clinically relevant findings to the rehabilitation field. I have recommended acceptance for publication on that basis. Interestingly, the reviewers have all highlighted that a much more detailed economic analysis will be presented separately which I will very much look forward to seeing.

The only comment I have remaining is regards to a comment regarding balance between arms after randomisation. I take the authors point that baseline statistical testing is not warranted and opposed by CONSORT (and randomisation has been reported and conducted appropriately). The question I had remaining was whether, from a clinical perspective whether the authors felt there could be potentially any influencing participant factors (if any), that would they would view as clinically relevant. Given that some imbalance occurs by chance, whether any these factors should or could be explored further perhaps in a post-hoc analyses as covariate adjustments to explore the influence on the results. Altman's 1985 paper has a few examples of exploring covariate adjustment principles by strength of prognostic factors but these are mostly decisions guided by clinical expertise and experience: "Comparability of Randomised Groups." Journal of the Royal Statistical Society. Series D (The Statistician), vol. 34, no. 1, 1985, pp. 125-136. JSTOR, www.jstor.org/stable/2987510. It would be useful to get the authors view on this.

Reviewer #2: The authors have done an excellent job responding to the comments. The manuscript is substantially improved and a stronger communication of the methods and results of this important trial. I only have a few mainly minor suggestions for the authors to consider:

Reviewer 1

Point 3 response: Instead of 'with allocation concealment' it would be more informative to state the method, such as 'assigned using a remotely prepared web-based randomisation system to…'

Point 19 response: The extra detail in the response about clinician assessed capacity for improvement is informative. It means that a pragmatic assessment was used, incorporating clinical judgement. I think clarification of this detail would be a useful addition to the paper and would aid generalisability.

Point 27 response: As the selected 15% difference was selected based on experience of what would be clinically important, it would be useful background to explain this in the sample size section. The relationship between the 15% clinically meaningful difference used in the sample size calculation and the effect sizes observed in the SPPB would be a useful point for the discussion to aid interpretation of the clinical importance.

Author summary: are the +/- SDs?; the 12 point SPPB results are in the what this study adds section, rather than the primary outcome (0-3 continuous SPPB)- would suggest the primary outcome data would be more appropriate.

Any attachments provided with reviews can be seen via the following link:

[LINK]

6 Dec 2019

Submitted filename: Response to Reviewer.docx

Click here for additional data file.

17 Dec 2019

Dear Dr. Hassett,

Thank you very much for re-submitting your manuscript "Digitally-enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: a randomised controlled trial." (PMEDICINE-D-19-02056R2) for review by PLOS Medicine.

I have discussed the paper with my colleagues and I am pleased to say that, provided the remaining editorial and production issues are dealt with, we are planning to accept the paper for publication in the journal.

The remaining issues that need to be addressed are listed at the end of this email. Please take these into account before resubmitting your manuscript:

[LINK]

Our publications team (plosmedicine@plos.org) will be in touch shortly about the production requirements for your paper, and the link and deadline for resubmission. DO NOT RESUBMIT BEFORE YOU'VE RECEIVED THE PRODUCTION REQUIREMENTS.

***Please note while forming your response, if your article is accepted, you may have the opportunity to make the peer review history publicly available. The record will include editor decision letters (with reviews) and your responses to reviewer comments. If eligible, we will contact you to opt in or out.***

In revising the manuscript for further consideration here, please ensure you address the specific points made by each reviewer and the editors. In your rebuttal letter you should indicate your response to the reviewers' and editors' comments and the changes you have made in the manuscript. Please submit a clean version of the paper as the main article file. A version with changes marked must also be uploaded as a marked up manuscript file.

Please also check the guidelines for revised papers at http://journals.plos.org/plosmedicine/s/revising-your-manuscript for any that apply to your paper. If you haven't already, we ask that you provide a short, non-technical Author Summary of your research to make findings accessible to a wide audience that includes both scientists and non-scientists. The Author Summary should immediately follow the Abstract in your revised manuscript. This text is subject to editorial change and should be distinct from the scientific abstract.

We expect to receive your revised manuscript within 1 week. Please email us (plosmedicine@plos.org) if you have any questions or concerns.

We ask every co-author listed on the manuscript to fill in a contributing author statement. If any of the co-authors have not filled in the statement, we will remind them to do so when the paper is revised. If all statements are not completed in a timely fashion this could hold up the re-review process. Should there be a problem getting one of your co-authors to fill in a statement we will be in contact. YOU MUST NOT ADD OR REMOVE AUTHORS UNLESS YOU HAVE ALERTED THE EDITOR HANDLING THE MANUSCRIPT TO THE CHANGE AND THEY SPECIFICALLY HAVE AGREED TO IT.

Please ensure that the paper adheres to the PLOS Data Availability Policy (see http://journals.plos.org/plosmedicine/s/data-availability), which requires that all data underlying the study's findings be provided in a repository or as Supporting Information. For data residing with a third party, authors are required to provide instructions with contact information for obtaining the data. PLOS journals do not allow statements supported by "data not shown" or "unpublished results." For such statements, authors must provide supporting data or cite public sources that include it.

If you have any questions in the meantime, please contact me or the journal staff on plosmedicine@plos.org.

We look forward to receiving the revised manuscript by Dec 20 2019 11:59PM.

Sincerely,

Louise Gaynor-Brook, MBBS PhD

Associate Editor

PLOS Medicine

plosmedicine.org

------------------------------------------------------------

Requests from Editors:

Thank you for adding to your revised manuscript information regarding the cost of the intervention, which we feel has improved the manuscript.

We note the addition of a new author. PLOS acts according to COPE guidelines, and so requires that any changes to the author listing on a manuscript are confirmed and agreed by all authors. All authors must fulfill the ICMJE criteria for authorship, and meet the CRediT guidelines for contributions, as described here: http://journals.plos.org/plosmedicine/s/authorship.

Please could you, as corresponding author, contact all authors - including the authors being added - to obtain their emailed confirmation that they agree to this change and the contributions made by the proposed new author? You should then forward all the confirmations to us in one file.

Thank you for confirming that access to de-identified data is still being considered by the lead ethics committee, and for suggesting an alternative contact (not an author) in the event that permission is not granted by the ethics committee. We will not be able to publish this work until this issue resolved.

We note that some of the modifications to the intervention protocol have been summarised in Table 1. Please provide the three versions published during the trial in the supplementary files.

You mention at line 479-481 that not finding “statistically significant difference in important participant-reported outcomes … may reflect low statistical power to demonstrate significance”. Please add this is as a limitation to the final sentence of your Abstract: Methods and Findings.

Line 174 - please specify the cities in which the hospitals were located (as you have in your Abstract)

Line 231 – please clarify whether a specific amount of time spent upright was required in order to record ‘upright time’ as an outcome

Please provide references to published questionnaires used in the study.

Line 429 - please revise to "Six of the devices were used across both inpatient and post-hospital care settings"

Line 448 – please replace ‘favourable’ with another term that clarifies the meaning of the sentence ‘Our results are more favourable than those of the Cochrane systematic review of virtual reality interventions in people after stroke’.

We note your response to our previous request to ‘Please provide justification for how results can be considered of clinical importance if ‘clinically important difference has not been established for this version of the SPPB’ Your explanation is still not clear; please clarify what exactly is meant by the comparison of your results with “the amount of deterioration over a 1- year period in older women living in the community with disability”, when this compares improvements in your primary mobility measure with worsening of mobility through deterioration. 0.2 points at 6 months compared to 0.15 points at 1 year does not appear convincingly clinically important to a non-expert reader.

Please indicate the relevant sections (e.g. Methods, etc) and paragraph numbers (instead of page numbers) in your CONSORT statement. As an online journal, papers published in PLOS Medicine do not have page numbers.

15 Jan 2020

Submitted filename: Response to Reviewer_20Dec2019.doc

Click here for additional data file.

22 Jan 2020

Dear Dr Hassett,

On behalf of my colleagues and the academic editor, Dr. Christelle Nguyen, I am delighted to inform you that your manuscript entitled "Digitally-enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: a randomised controlled trial." (PMEDICINE-D-19-02056R3) has been accepted for publication in PLOS Medicine.

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Thank you again for submitting the manuscript to PLOS Medicine. We look forward to publishing it.

Best wishes,

Louise Gaynor-Brook, MBBS PhD

Associate Editor

PLOS Medicine

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