Background and Purpose- The aim of this trial was to determine the effect of additional upper limb rehabilitation following
botulinum toxin-A for upper limb activity in chronic
stroke. Methods- We conducted a multicenter phase III randomized trial with concealed allocation, blinded measurement, and intention-to-treat analysis. One hundred forty
stroke survivors who were scheduled to receive
botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a
stroke >3 months ago, who had completed formal rehabilitation and had no significant
cognitive impairment. Experimental group received
botulinum toxin-A plus evidence-based movement training while the control group received
botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at 3 months (end of intervention). Secondary outcomes were spasticity, range of motion, strength,
pain, burden of care, and health-related quality of life. Results- In terms of goal attainment, the experimental group scored the same (mean difference, 2 T-score [95% CI, -2 to 7]) as the control group on the Goal Attainment Scale. In terms of upper limb activity, by 3 months the experimental group moved blocks at the same speed (mean difference, 0.00 blocks/s [95% CI, -0.02 to 0.01]) as the control group on the Box and Block Test. There were no differences between groups on any secondary outcome except strength, in favor of the experimental group (mean difference, 1.4 kg [95% CI, 0.2-2.7]). Conclusions- Findings suggest that additional intensive upper limb rehabilitation following
botulinum toxin-A in chronic
stroke survivors with a disabled upper limb is not effective. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: ACTRN12615000616572.