A Preliminary Assessment of the Benefits of the Addition of Botulinum Toxin A to a Conventional Therapy Program on the Function of People With Longstanding Stroke

Abstract 

Meythaler JM, Vogtle L, Brunner RC. A preliminary assessment of the benefits of the addition of botulinum toxin A to a conventional therapy program on the function of people with longstanding stroke.

Objective

To determine if botulinum toxin type A (BTX-A) combined with therapy can facilitate improved upper-extremity (UE) functional status versus therapy alone.

Design

Double-blind randomized crossover trial.

Setting

Tertiary care outpatient rehabilitation center.

Participants

Convenience sample of 21 men and women (ages 19–80y) with stroke more than 6 months after insult who had tone greater than 3 on the Ashworth Scale for 2 joints in the involved UE.

Intervention

Subjects were consecutively recruited and randomized to a double-blind crossover trial. Subjects received either BTX-A combined with a defined therapy program or placebo injection combined with a therapy program in two 12-week sessions.

Main Outcome Measures

The primary functional outcome measure was the Motor Activity Log (MAL). Subjects were also assessed on physiologic measures including tone (Ashworth Scale), range of motion, and motor strength.

Results

Improvements were noted in the functional status of the subjects in both arms of the study as measured by the MAL. All subjects had a significant change in functional status on MAL with therapy (P<.05). The use of BTX-A combined with therapy as compared with therapy only improved the functional status of the subjects on the MAL Quality of Movement subscale (P=.0180, t test) and showed a trend toward significance in the Amount of Use subscale (P=.0605, analysis of variance). Six weeks after treatment, the BTX-A combined with therapy decreased the Ashworth score statistically (P=.0271), but the therapy alone group decreased a similar amount at 6 weeks (P=.0117), indicating that most of the physiologic tone change could be attributed to therapy. After each 12-week period, tone had largely returned to baseline (P>.05).

Conclusion

A focused therapy program showed the most improvement in function in this defined stroke population. BTX-A combined with a focused traditional therapy program slightly enhanced the functional status of stroke subjects beyond that obtained with therapy alone 12 weeks after injection.

Key Words: Activities of daily living, Botulinum toxins, Humans, Intramuscular injections, Rehabilitation, Spasticity, Stroke, Therapy

List of Abbreviations: ANOVA, analysis of variance, AOU, amount of use, BTX-A, botulinum toxin type A, CNS, central nervous system, MAL, Motor Activity Log, MOS, Medical Outcomes Study, QOM, quality of movement, ROM, range of motion, UE, upper extremity