At a glance
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Open-label, Parallel Study to Determine the Efficacy and Safety of Botulinum Neurotoxin A Paired With Rehabilitation Therapy vs. Botulinum Neurotoxin A Alone for the Treatment of Post-stroke Upper Limb Spasticity
In Brief
A clinical study evaluating Botulinum toxin type A, BoNT-A and Rehabilitation Therapy for Upper Limb Spasticity. Completed, enrolled 31 participants across 1 site.
Detailed Summary
The purpose of this study is to determine if a combination of botulinum neurotoxin A and rehabilitation therapy is better than botulinum neurotoxin A alone for improvement in function based on the Fugl-Meyer and other validated measures. Hypothesis: The combination of botulinum neurotoxin A and rehabilitation therapy will produce better functional improvement than botulinum neurotoxin A alone in post-stroke upper limb spasticity measured by the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke.
Study Details
Timeline
Interventions
Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
Rehabilitation therapy