Intensive therapy after botulinum toxin in adults with spasticity after stroke versus botulinum toxin alone or therapy alone: A pilot, feasibility randomized trial

Natasha A. Lannin, Louise Ada, Tamina Levy, Coralie English, Julie Ratcliffe, Doungkamol Sindhusake, Maria Crotty

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3 Citations (Scopus)

Abstract

Background: Botulinum toxin-A is provided for adults with post-stroke spasticity. Following injection, there is a variation in the rehabilitation therapy type and amount provided. The purpose of this study was to determine if it is feasible to add intensive therapy to botulinum toxin-A injections for adults with spasticity and whether it is likely to be beneficial. Methods: Randomized trial with concealed allocation, assessor blinding, and intention to treat analysis. Thirty-seven adults (n = 3 incomplete or lost follow-up) with spasticity in the upper or lower limb were allocated to one of three groups: Experimental group received a single dose of botulinum toxin-A plus an intensive therapy for 8 weeks, control group 1 received a single dose of botulinum toxin-A only, and control group 2 received intensive therapy only for 8 weeks. Feasibility was measured by examining recruitment, intervention (adherence, acceptability, safety), and measurement. Benefit was measured as goal achievement (Goal Attainment Scale), upper limb activity (Box and Block Test), walking (6-min walk test) and spasticity (Tardieu scale), at baseline (week 0), immediately after (week 8), and at three months (week 12). Results: Overall recruitment fraction for the trial was 37% (eligibility fraction 39%, enrolment fraction 95%). The 26 participants allocated to receive intensive rehabilitation attended 97% of clinic-based sessions (mean 11 ± 2 h) and an averaged 58% (mean 52 ± 32 h) of prescribed 90 h of independent practice. There were no study-related adverse events reported. Although participants in all groups increased their goal attainment, there were no between-group differences for this or other outcomes at week 8 or 12. Conclusion: Providing intensive therapy following botulinum toxin-A is feasible for adults with neurological spasticity. The study methods are appropriate for a future trial. A future trial would require 134 participants to detect a betweengroup difference of 7 points on Goal Attainment Scale t-scores with an alpha of 0.05 and power of 80%.

Original languageEnglish
Article number82
Number of pages9
JournalPilot and Feasibility Studies
Volume4
Issue number1
DOIs
Publication statusPublished - 25 Apr 2018
Externally publishedYes

Keywords

  • Botulinum toxins
  • Muscle spasticity
  • Occupational therapy
  • Physical therapy
  • Rehabilitation
  • Stroke

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