Additional, Mechanized Upper Limb Self-Rehabilitation in Patients With Subacute Stroke: The REM-AVC Randomized Trial.

Autor: Rémy-Néris O; Physical and Rehabilitation Medicine Department (O.R.-N., B.M., É.P.), Brest University Hospital, France.; University of Brest, France (O.R.-N.).; Laboratory of Medical Information Processing, INSERM UMR 1101, Brest, France (O.R.-N., B.M.)., Le Jeannic A; Health Economics Clinical Research Unit (URC Eco), APHP, Paris, France (A.L.J., I.D.-Z.)., Dion A; INSERM, CIC 1412 (A.D., E.N.), Brest University Hospital, France., Médée B; Physical and Rehabilitation Medicine Department (O.R.-N., B.M., É.P.), Brest University Hospital, France.; Laboratory of Medical Information Processing, INSERM UMR 1101, Brest, France (O.R.-N., B.M.)., Nowak E; INSERM, CIC 1412 (A.D., E.N.), Brest University Hospital, France., Poiroux É; Physical and Rehabilitation Medicine Department (O.R.-N., B.M., É.P.), Brest University Hospital, France., Durand-Zaleski I; Health Economics Clinical Research Unit (URC Eco), APHP, Paris, France (A.L.J., I.D.-Z.).
Jazyk: angličtina
Zdroj: Stroke [Stroke] 2021 Jun; Vol. 52 (6), pp. 1938-1947. Date of Electronic Publication: 2021 Apr 29.
DOI: 10.1161/STROKEAHA.120.032545
Abstrakt: Background and Purpose: Additional therapy may improve poststroke outcomes. Self-rehabilitation is a useful means to increase rehabilitation time. Mechanized systems are usual means to extend time for motor training. The primary aim was to compare the effects of self-rehabilitation using a mechanized device with control self-exercises on upper extremity impairment in patients with stroke.
Methods: Phase III, parallel, concealed allocation, randomized controlled, multicenter trial, with 12-month follow-up. Patients aged 18 to 80 years, 3 weeks to 3 months poststroke with a Fugl-Meyer Assessment score of 10 to 40 points, were randomized to the Exo or control groups. All undertook two 30-minute self-rehabilitation sessions/day, 5 days/wk for 4 weeks in addition to usual rehabilitation. The Exo group performed games-based exercises using a gravity-supported mechanical exoskeleton (Armeo Spring). The control group performed stretching plus basic active exercises. Primary outcome was change in upper extremity Fugl-Meyer Assessment score at 4 weeks.
Results: Two hundred fifteen participants were randomly allocated to the Exo group (107) or the control group (108). Mean age (SD), 58.3 (13.6) years; mean time poststroke, 54.8 (22.1) days; and mean baseline Fugl-Meyer Assessment score, 26.1 (9.5). There was no between-group difference in mean change in Fugl-Meyer Assessment score following the intervention: 13.3 (9.0) in the Exo group and 11.8 (8.8) in the control group (P=0.22). There were no significant between-group differences in changes for any of the other outcomes at any time point (except for perception of the self-rehabilitation). There was no between-group difference in cost utility at 12 months.
Conclusions: In patients with moderate-to-severe impairment in the subacute phase of stroke, the purchase and use of complex devices to provide additional upper limb training may not be necessary: simply educating patients to regularly move and stretch their limbs appears sufficient.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01383512.
Databáze: MEDLINE