Original Title: Rehabilitación del miembro superior asistida por exoesqueleto robótico en pacientes con enfermedad cerebrovascular: eficacia y seguridad. Revisión sistemática

Authors' objectives: To evaluate the efficacy and safety of rehabilitation assisted by a robotic exoskeleton compared to conventional rehabilitation in patients with upper limb motor deficits secondary to cerebrovascular disease.

Authors' results and conclusions: Results: We included 11 clinical trials published between 2007 and 2022 and carried out in 6 countries in Europe, Asia, and America that analyzed a total of 594 patients were included. The average age of the participants ranged between 47 and 73 years, and the average baseline score on the activity of daily living was 54.3 (± 21.8) points measured with the Barthel index (BI) questionnaire. The included studies evaluated different types of robotic exoskeletons with different therapeutic parameters (frequency, duration and number of sessions). All of them used conventional rehabilitation as a comparator. Patient follow-up in the included studies ranged from 4 to 24 weeks postintervention. As a result, in terms of effectiveness, the cumulative analyzes showed significant differences in favour of exoskeleton-assisted rehabilitation compared to conventional rehabilitation in terms of activity of daily living (standardized mean difference -SMD-: 0.42; 95 % interval confidence-CI-: 0.15 to 0.69; 9 trials; 485 patients; p = 0.002; I2: 46 %; low-certainty evidence), and upper limb motor function (SMD:0.29; CI 95 %: 0.10 to 0.48; p = 0.003, I2: 0 %; moderate-quality evidence) immediately after the intervention. However, we found non-significant effects in a longer-term follow-up of these variables (up to 6 months later), nor in the improvement in arm strength measured immediately at the end of rehabilitation and further follow-up period (low or very low-quality evidence). In the subgroup analyzes performed to explore possible effect modifiers, we did not identify any consistent and significant impact of factors such as the clinical stage of CVA at the time of the intervention or the degree of baseline upper limb disability. Sensitivity analyses revealed results similar to those of the overall analysis. In terms of safety, we did not find evidence of a significant effect of exoskeletonassisted robotic rehabilitation compared to conventional rehabilitation concerning the number of dropouts/losses (low-quality evidence) (risk difference-RD-: -0.01 (95 % CI -0.03 to 0.02, p = 0.47, I2: 0 %, low-quality evidence.) Robotic rehabilitation with exoskeletons is generally described as a well-tolerated procedure and not associated with adverse events with significant clinical impact. The most frequently described side effects were the appearance of muscle fatigue, pain and/or skin changes related to the robotic device during the test procedure. Conclusions: Low to moderate certainty evidence suggests exoskeleton-assisted robotic rehabilitation can slightly improve the performance of daily activities and upper limb function immediately after the rehabilitation program. However, there are no significant differences in longer-term follow-ups or outcomes, such as the strength of the affected limb. The study results show that the exoskeleton-assisted robotic rehabilitation program is comparable to conventional rehabilitation in terms of tolerability and safety.

Authors' methods: We conducted specific search strategies to identify relevant studies in the following electronic databases were consulted: Ovid MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Physiotherapy Evidence Database (PEDRO), Science Citation Index expanded (SCI), SPORTDiscus (EBSCO), International Clinical Trials Registry Platform (ICTRP) Search Portal, and clinicalTrials.gov. Clinical trials published in any language were included that analyzed the effect of exoskeleton-assisted robotic rehabilitation on efficacy outcomes (changes from baseline in activities of daily living, motor function and strength of the affected upper extremity) and safety (tolerance or acceptability to treatment and adverse effects) in people with motor deficits secondary to stroke and compared with conventional rehabilitation. Two independent reviewers selected the studies and extracted relevant data while assessing the risk of bias using the Cochrane Collaboration's Risk of Bias tool (version 2) for clinical trials. Wherever possible, a meta-analysis of treatment effects was performed using a randomeffects model and statistical heterogeneity was estimated. The GradePro tool was used to assess the quality of the evidence.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/rehabilitacion-del-miembro-superior-asistida-por-exoesqueleto-robotico-en-pacientes-con-enfermedad-cerebrovascular-eficacia-y-seguridad-revision-sistematica/

Year Published: 2025

URL for published report: https://www.aetsa.org/download/publicaciones/Rehabilitacion-robotica_web.pdf

Requestor: Spanish Health Ministry

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

DOI: 10.52766/LQLH5522

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: <p>Andalusian Agency for Health Technology Assessment (AETSA)</p>