Further assessment to determine the additive effect of botulinum toxin type A on an upper extremity exercise program to enhance function among individuals with chronic stroke but extensor capability

Abstract

Objective: To determine whether dose-specified botulinum toxin type A (BTX-A) and a standardized exercise protocol produce better upper extremity function than placebo and the same exercise program.

Design: Double-blind randomized trial.

Setting: A rehabilitation research center.

Participants: A convenience sample of patients (N=25, age range, 23-76 y) who sustained a stroke 3 to 24 months previously but could initiate wrist extension.

Interventions: Participants were randomly selected to receive either BTX-A (maximum 300 U) or saline, followed by 12 to 16 exercise sessions.

Main outcome measures: The primary outcome was the Wolf Motor Function Test (WMFT). Secondary outcome measures included the Modified Ashworth Scale (MAS), active range of motion, and the Stroke Impact Scale (SIS; quality of life).

Results: There were no group-by-time interactions for changes in the WMFT and no treatment difference (P=.86), although the BTX-A group could complete more tasks governing proximal joint motions. MAS scores improved for the BTX-A group and worsened for the control group after injection (P=.02), as did the SIS emotion domain (P=.035).

Conclusions: Among chronic stroke survivors, BTX-A did not impact function, movement, or tone more than a standardized exercise program.