Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: The InTENSE Trial

Natasha A. Lannin, Louise Ada, Coralie English, Julie Ratcliffe, Steven G. Faux, Mithu Palit, Senen Gonzalez, John Olver, Ian Cameron, Maria Crotty, InTENSE Trial Group

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Abstract

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.

Original languageEnglish
Pages (from-to)556-562
Number of pages7
JournalStroke
Volume51
Issue number2
DOIs
Publication statusPublished - Feb 2020

Bibliographical note

This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.

Keywords

  • botulinum toxin type A
  • neuroscience
  • pain
  • quality of life
  • spasticity
  • wrist
  • Botulinum toxin type A

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