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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.

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Background It is common for people with persistent spasticity due to a stroke to receive an injection of botulinum toxin-A in the upper limb, however post-injection intervention varies. Aim To determine the long-term effect of additional upper limb rehabilitation following botulinum toxin-A in chronic stroke. Method An analysis of long-term outcomes from national, multicenter, Phase III randomised trial with concealed allocation, blinded measurement and intention-to-treat analysis was carried out. Participants were 140 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 greater than 3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus 3 months of evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scale) and upper limb activity (Box and Block Test) at 12 months (ie, 9 months beyond the intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life. Results By 12 months, the experimental group scored the same as the control group on the Goal Attainment Scale (MD 0 T-score, 95% CI -5 to 5) and on the Box and Block Test (MD 0.01 blocks/s, 95% CI -0.01 to 0.03). There were no differences between groups on any secondary outcome. Conclusion Additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not more effective in the long-term. Trial Registration ACTRN12615000616572 (12/06/2015).

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