Botulinum toxin A in the treatment of hemiplegic spastic foot drop--clinical and functional outcomes.

PURPOSE OF STUDY

This study investigated the effects of intramuscular Botulinum toxin A (BTX-A) in 7 ambulatory chronic hemiplegic subjects (5 male, 2 female) who had spastic hemiplegic foot drop.

BASIC PROCEDURES

An open label study involving intramuscular injections of Botulinum toxin A (dilution 10 U/0.1 ml) was performed in ambulatory chronic hemiplegics. Tone as measured by the Modified Ashworth Scale (MAS), passive ankle joint range of motion (PROM), briskness of ankle reflexes, gait velocity, motor functional status and effects on the use of walking aids were measured at baseline, 3 and 12 weeks post-injection.

MAIN FINDINGS

All subjects except I showed a significant decrease in MAS from 3.43 +/- 0.54 at baseline to 2.0 +/- 1.15 at 3 weeks post-injection, which was maintained during the 3 month study duration. The median change in PROM was 17.0 degrees (SD 12.1 degrees) at 3 weeks and 5.0 degrees (SD 7.1 degrees) at 12 weeks (p = 0.25) Gait velocity and Modified Barthel Index mobility scores which measured motor functional status were not significantly altered post-injection. The injections were generally well-tolerated and there were no serious adverse side effects.

PRINCIPAL CONCLUSIONS

Although significant decreases in muscle tone were observed and maintained after intramuscular Botulinum toxin A during the 3 month study period, this regional intervention did not significantly influence functional status, gait velocity and the use of ambulatory aids.