OBJECTIVE: To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke. DESIGN: Parallel-group pilot RCT. SETTING: Four English stroke services. PARTICIPANTS: Patients 0-3 months post stroke with a new arm deficit. INTERVENTION: Participants were randomized to wear a prompting or 'sham' wristband during a four-week self-directed therapy programme with twice-weekly therapy review. MAIN OUTCOMES: Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison. RESULTS: In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26 days (interquartile range (IQR):15.5-45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group (n = 19) were 15 (2-35), 35 (15-26) and 31 (21-55) and those for the intervention group (n = 14) were 37 (16-45), 57 (29-57) and 57 (37-57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0-1.2), 1.1 (0.3-2.9) and 1.2 (0.7-2.9) and in the intervention group were 1.4 (0.5-2.6), 3.8 (1.9-4.5) and 3.7 (2.1-4.3). Four participants withdrew from the study. Wristbands were worn for 79% of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3-8.0) and 7.5 (IQR: 6.8-8.0) therapy reviews. A median of 8 (IQR: 6-10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention. CONCLUSION: A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required.
OBJECTIVE: To evaluate the feasibility of a multicentre, observer-blind, pilot randomized controlled trial (RCT) of a wristband accelerometer with activity-dependent vibration alerts to prompt impaired arm use after stroke. DESIGN: Parallel-group pilot RCT. SETTING: Four English stroke services. PARTICIPANTS: Patients 0-3 months post stroke with a new arm deficit. INTERVENTION: Participants were randomized to wear a prompting or 'sham' wristband during a four-week self-directed therapy programme with twice-weekly therapy review. MAIN OUTCOMES: Recruitment, retention and adherence rates, safety and completion of assessments were reported. Arm recovery was measured by Action Research Arm Test (ARAT) and Motor Activity Log (MAL) without statistical comparison. RESULTS: In total, 33 patients were recruited (0.6 per month/site; median time post stroke: 26 days (interquartile range (IQR):15.5-45)). Baseline, four-week and eight-week median (IQR) ARAT for the control group (n = 19) were 15 (2-35), 35 (15-26) and 31 (21-55) and those for the intervention group (n = 14) were 37 (16-45), 57 (29-57) and 57 (37-57), respectively; for MAL Amount of Use, the corresponding values in the control group were 0.2 (0.0-1.2), 1.1 (0.3-2.9) and 1.2 (0.7-2.9) and in the intervention group were 1.4 (0.5-2.6), 3.8 (1.9-4.5) and 3.7 (2.1-4.3). Four participants withdrew from the study. Wristbands were worn for 79% of the recommended time. The intervention and control group participants received a median of 6.0 (IQR: 4.3-8.0) and 7.5 (IQR: 6.8-8.0) therapy reviews. A median of 8 (IQR: 6-10) prompts were delivered per intervention participant/day. Research assessments were completed for 28/29 and 25/28 patients at four and eight weeks. Eight serious adverse events were reported, all unrelated to the intervention. CONCLUSION: A multicentre RCT of wristband accelerometers to prompt arm activity early after stroke is feasible. A total sample of 108 participants would be required.
Authors: Lisa A Simpson; Ruth Barclay; Mark T Bayley; Sean P Dukelow; Bradley J MacIntosh; Marilyn MacKay-Lyons; Carlo Menon; W Ben Mortenson; Tzu-Hsuan Peng; Courtney L Pollock; Sepideh Pooyania; Robert Teasell; Chieh-Ling Yang; Jennifer Yao; Janice J Eng Journal: Trials Date: 2022-02-08 Impact factor: 2.728
Authors: Francesco Negrini; Giulio Gasperini; Eleonora Guanziroli; Jacopo Antonino Vitale; Giuseppe Banfi; Franco Molteni Journal: Int J Environ Res Public Health Date: 2020-05-02 Impact factor: 3.390