Long-term effect of additional rehabilitation following botulinum toxin-A on upper limb activity in chronic stroke: the InTENSE randomised trial

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).