Luciana A Mendes1, Illia Ndf Lima2, Tulio Souza3, George C do Nascimento4, Vanessa R Resqueti5, Guilherme Af Fregonezi6. 1. Federal University of Rio Grande do Norte, PneumoCardioVascular Lab, Onofre Lopes University Hospital, Brazilian Company of Hospital Services (EBSERH) & Department of Biomedical Engineering, Natal, Rio Grande do Norte, Brazil, 59078-970. 2. Federal University of Rio Grande do Norte, Faculty of Health Sciences of Trairi, Santa Cruz, Rio Grande do Norte, Brazil, 59200-000. 3. Federal University of Rio Grande do Norte, Department of Physical Therapy, Natal, Brazil, 59078-970. 4. Federal University of Rio Grande do Norte, Department of Biomedical Engineering, Caixa Postal 1524 - Campus Universitário Lagoa Nova, Departamento de Engenharia Biomédica, Natal, Rio Grande do Norte, Brazil, 59078-970. 5. Federal University of Rio Grande do Norte, PneumoCardioVascular Lab, Onofre Lopes University Hospital, Brazilian Company of Hospital Services (EBSERH) & Department of Physical Therapy, Campus Universitario Lagoa Nova, Caixa Postal 1524, Natal, Rio Grande do Norte, Brazil, 59078-970. 6. Onofre Lopes University Hospital, Brazilian Company of Hospital Services (EBSERH), PneumoCardioVascular Lab, Natal, Rio Grande do Norte, Brazil, 59078-970.
Abstract
BACKGROUND: Motor neuroprosthesis (MN) involves electrical stimulation of neural structures by miniaturized devices to allow the performance of tasks in the natural environment in which people live (home and community context), as an orthosis. In this way, daily use of these devices could act as an environmental facilitator for increasing the activities and participation of people with stroke. OBJECTIVES: To assess the effects of MN for improving independence in activities of daily living (ADL), activities involving limbs, participation scales of health-related quality of life (HRQoL), exercise capacity, balance, and adverse events in people after stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (searched 19 August 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (August 2019), MEDLINE (1946 to 16 August 2019), Embase (1980 to 19 August 2019), and five additional databases. We also searched trial registries, databases, and websites to identify additional relevant published, unpublished, and ongoing trials. SELECTION CRITERIA: Randomized controlled trials (RCTs) and randomized controlled cross-over trials comparing MN for improving activities and participation versus other assistive technology device or MN without electrical stimulus (stimulator is turned off), or no treatment, for people after stroke. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, extracted data, and assessed risk of bias of the included studies. Any disagreements were resolved through discussion with a third review author. We contacted trialists for additional information when necessary and performed all analyses using Review Manager 5. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included four RCTs involving a total of 831 participants who were more than three months poststroke. All RCTs were of MN that applied electrical stimuli to the peroneal nerve. All studies included conditioning protocols to adapt participants to MN use, after which participants used MN from up to eight hours per day to all-day use for ambulation in daily activities performed in the home or community context. All studies compared the use of MN versus another assistive device (ankle-foot orthosis [AFO]). There was a high risk of bias for at least one assessed domain in three of the four included studies. No studies reported outcomes related to independence in ADL. There was low-certainty evidence that AFO was more beneficial than MN on activities involving limbs such as walking speed until six months of device use (mean difference (MD) -0.05 m/s, 95% confidence interval (CI) -0.10 to -0.00; P = 0.03; 605 participants; 2 studies; I2 = 0%; low-certainty evidence); however, this difference was no longer present in our sensitivity analysis (MD -0.07 m/s, 95% CI -0.16 to 0.02; P = 0.13; 110 participants; 1 study; I2 = 0%). There was low to moderate certainty that MN was no more beneficial than AFO on activities involving limbs such as walking speed between 6 and 12 months of device use (MD 0.00 m/s, 95% CI -0.05 to 0.05; P = 0.93; 713 participants; 3 studies; I2 = 17%; low-certainty evidence), Timed Up and Go (MD 0.51 s, 95% CI -4.41 to 5.43; P = 0.84; 692 participants; 2 studies; I2 = 0%; moderate-certainty evidence), and modified Emory Functional Ambulation Profile (MD 14.77 s, 95% CI -12.52 to 42.06; P = 0.29; 605 participants; 2 studies; I2 = 0%; low-certainty evidence). There was no significant difference in walking speed when MN was delivered with surface or implantable electrodes (test for subgroup differences P = 0.09; I2 = 65.1%). For our secondary outcomes, there was very low to moderate certainty that MN was no more beneficial than another assistive device for participation scales of HRQoL (standardized mean difference 0.26, 95% CI -0.22 to 0.74; P = 0.28; 632 participants; 3 studies; I2 = 77%; very low-certainty evidence), exercise capacity (MD -9.03 m, 95% CI -26.87 to 8.81; P = 0.32; 692 participants; 2 studies; I2 = 0%; low-certainty evidence), and balance (MD -0.34, 95% CI -1.96 to 1.28; P = 0.68; 692 participants; 2 studies; I2 = 0%; moderate-certainty evidence). Although there was low- to moderate-certainty evidence that the use of MN did not increase the number of serious adverse events related to intervention (risk ratio (RR) 0.35, 95% CI 0.04 to 3.33; P = 0.36; 692 participants; 2 studies; I2 = 0%; low-certainty evidence) or number of falls (RR 1.20, 95% CI 0.92 to 1.55; P = 0.08; 802 participants; 3 studies; I2 = 33%; moderate-certainty evidence), there was low-certainty evidence that the use of MN in people after stroke may increase the risk of participants dropping out during the intervention (RR 1.48, 95% CI 1.11 to 1.97; P = 0.007; 829 participants; 4 studies; I2 = 0%). AUTHORS' CONCLUSIONS: Current evidence indicates that MN is no more beneficial than another assistive technology device for improving activities involving limbs measured by Timed Up and Go, balance (moderate-certainty evidence), activities involving limbs measured by walking speed and modified Emory Functional Ambulation Profile, exercise capacity (low-certainty evidence), and participation scale of HRQoL (very low-certainty evidence). Evidence was insufficient to estimate the effect of MN on independence in ADL. In comparison to other assistive devices, MN does not appear to increase the number of falls (moderate-certainty evidence) or serious adverse events (low-certainty evidence), but may result in a higher number of dropouts during intervention period (low-certainty evidence).
BACKGROUND: Motor neuroprosthesis (MN) involves electrical stimulation of neural structures by miniaturized devices to allow the performance of tasks in the natural environment in which people live (home and community context), as an orthosis. In this way, daily use of these devices could act as an environmental facilitator for increasing the activities and participation of people with stroke. OBJECTIVES: To assess the effects of MN for improving independence in activities of daily living (ADL), activities involving limbs, participation scales of health-related quality of life (HRQoL), exercise capacity, balance, and adverse events in people after stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (searched 19 August 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (August 2019), MEDLINE (1946 to 16 August 2019), Embase (1980 to 19 August 2019), and five additional databases. We also searched trial registries, databases, and websites to identify additional relevant published, unpublished, and ongoing trials. SELECTION CRITERIA: Randomized controlled trials (RCTs) and randomized controlled cross-over trials comparing MN for improving activities and participation versus other assistive technology device or MN without electrical stimulus (stimulator is turned off), or no treatment, for people after stroke. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, extracted data, and assessed risk of bias of the included studies. Any disagreements were resolved through discussion with a third review author. We contacted trialists for additional information when necessary and performed all analyses using Review Manager 5. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included four RCTs involving a total of 831 participants who were more than three months poststroke. All RCTs were of MN that applied electrical stimuli to the peroneal nerve. All studies included conditioning protocols to adapt participants to MN use, after which participants used MN from up to eight hours per day to all-day use for ambulation in daily activities performed in the home or community context. All studies compared the use of MN versus another assistive device (ankle-foot orthosis [AFO]). There was a high risk of bias for at least one assessed domain in three of the four included studies. No studies reported outcomes related to independence in ADL. There was low-certainty evidence that AFO was more beneficial than MN on activities involving limbs such as walking speed until six months of device use (mean difference (MD) -0.05 m/s, 95% confidence interval (CI) -0.10 to -0.00; P = 0.03; 605 participants; 2 studies; I2 = 0%; low-certainty evidence); however, this difference was no longer present in our sensitivity analysis (MD -0.07 m/s, 95% CI -0.16 to 0.02; P = 0.13; 110 participants; 1 study; I2 = 0%). There was low to moderate certainty that MN was no more beneficial than AFO on activities involving limbs such as walking speed between 6 and 12 months of device use (MD 0.00 m/s, 95% CI -0.05 to 0.05; P = 0.93; 713 participants; 3 studies; I2 = 17%; low-certainty evidence), Timed Up and Go (MD 0.51 s, 95% CI -4.41 to 5.43; P = 0.84; 692 participants; 2 studies; I2 = 0%; moderate-certainty evidence), and modified Emory Functional Ambulation Profile (MD 14.77 s, 95% CI -12.52 to 42.06; P = 0.29; 605 participants; 2 studies; I2 = 0%; low-certainty evidence). There was no significant difference in walking speed when MN was delivered with surface or implantable electrodes (test for subgroup differences P = 0.09; I2 = 65.1%). For our secondary outcomes, there was very low to moderate certainty that MN was no more beneficial than another assistive device for participation scales of HRQoL (standardized mean difference 0.26, 95% CI -0.22 to 0.74; P = 0.28; 632 participants; 3 studies; I2 = 77%; very low-certainty evidence), exercise capacity (MD -9.03 m, 95% CI -26.87 to 8.81; P = 0.32; 692 participants; 2 studies; I2 = 0%; low-certainty evidence), and balance (MD -0.34, 95% CI -1.96 to 1.28; P = 0.68; 692 participants; 2 studies; I2 = 0%; moderate-certainty evidence). Although there was low- to moderate-certainty evidence that the use of MN did not increase the number of serious adverse events related to intervention (risk ratio (RR) 0.35, 95% CI 0.04 to 3.33; P = 0.36; 692 participants; 2 studies; I2 = 0%; low-certainty evidence) or number of falls (RR 1.20, 95% CI 0.92 to 1.55; P = 0.08; 802 participants; 3 studies; I2 = 33%; moderate-certainty evidence), there was low-certainty evidence that the use of MN in people after stroke may increase the risk of participants dropping out during the intervention (RR 1.48, 95% CI 1.11 to 1.97; P = 0.007; 829 participants; 4 studies; I2 = 0%). AUTHORS' CONCLUSIONS: Current evidence indicates that MN is no more beneficial than another assistive technology device for improving activities involving limbs measured by Timed Up and Go, balance (moderate-certainty evidence), activities involving limbs measured by walking speed and modified Emory Functional Ambulation Profile, exercise capacity (low-certainty evidence), and participation scale of HRQoL (very low-certainty evidence). Evidence was insufficient to estimate the effect of MN on independence in ADL. In comparison to other assistive devices, MN does not appear to increase the number of falls (moderate-certainty evidence) or serious adverse events (low-certainty evidence), but may result in a higher number of dropouts during intervention period (low-certainty evidence).
Authors: Emerson Fachin Martins; Lidiane Teles de Menezes; Pedro Henrique Côrtes de Sousa; Paulo Henrique Ferreira de Araujo Barbosa; Abraão Souza Costa Journal: NeuroRehabilitation Date: 2012 Impact factor: 2.138
Authors: Alessandro Liberati; Douglas G Altman; Jennifer Tetzlaff; Cynthia Mulrow; Peter C Gøtzsche; John P A Ioannidis; Mike Clarke; P J Devereaux; Jos Kleijnen; David Moher Journal: PLoS Med Date: 2009-07-21 Impact factor: 11.069
Authors: Luciana A Mendes; Illia Ndf Lima; Tulio Souza; George C do Nascimento; Vanessa R Resqueti; Guilherme Af Fregonezi Journal: Cochrane Database Syst Rev Date: 2020-01-14
Authors: Luciana A Mendes; Illia Ndf Lima; Tulio Souza; George C do Nascimento; Vanessa R Resqueti; Guilherme Af Fregonezi Journal: Cochrane Database Syst Rev Date: 2020-01-14