Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
The present study is designed to determine the safety and effectiveness of injections of
BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would
do nothing) when combined with rehabilitation therapy for the improvement of active function
tasks in post-stroke patients. Injections will be targeted to reduce common spasticity
patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist,
thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory
University. Neither the doctor injecting the drug nor the subject receiving the drug will
know if they are getting BOTOX® or saline. Which type of injection the subject receives will
be completely randomized (like flipping a coin). All subjects will have rehabilitation
therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits
(qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects
will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5
times a week, for 4 weeks. The results from this project will provide valuable data on the
ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic
muscles of the arm and hand after stroke. This project has the potential to increase the
availability of effective rehabilitation techniques to patients with stroke.
Phase:
Early Phase 1
Details
Lead Sponsor:
Emory University
Collaborator:
Allergan
Treatments:
abobotulinumtoxinA Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA Polystyrene sulfonic acid