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Rehabilitation plus OnabotulinumtoxinA improves motor function over OnabotulinumtoxinA alone in post-stroke upper limb spasticity: a single-blind, randomized trial
Devier D, Harnar J, Lopez L, Brashear A, Graham G
Toxins 2017 Jul 11;9(7):216
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: OnabotulinumtoxinA (BoNT-A) can temporarily decrease spasticity following stroke, but whether there is an associated improvement in upper limb function is less clear. This study measured the benefit of adding weekly rehabilitation to a background of BoNT-A treatments for chronic upper limb spasticity following stroke. METHODS: This was a multi-center clinical trial. Thirty-one patients with post-stroke upper limb spasticity were treated with BoNT-A. They were then randomly assigned to 24 weeks of weekly upper limb rehabilitation or no rehabilitation. They were injected up to two times, and followed for 24 weeks. The primary outcome was change in the Fugl-Meyer upper extremity score, which measures motor function, sensation, range of motion, coordination, and speed. RESULTS: The 'rehab' group significantly improved on the Fugl-Meyer upper extremity score (visit 1 = 60, visit 5 = 67) while the 'no rehab' group did not improve (visit 1 = 59, visit 5 = 59; p = 0.006). This improvement was largely driven by the upper extremity "movement" subscale, which showed that the 'rehab' group was improving (visit 1 = 33, visit 5 = 37) while the 'no rehab' group remained virtually unchanged (visit 1 = 34, visit 5 = 33; p = 0.034). CONCLUSIONS: Following injection of BoNT-A, adding a program of rehabilitation improved motor recovery compared to an injected group with no rehabilitation.

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