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The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke

2014-08-27 03:15:10 | BioPortfolio

Summary

The purpose of this study is to see whether treating subjects for wrist rehabilitation following stroke with Botox® and robotic therapy is more effective than treatment with robotic therapy alone and no Botox®.

Description

This study will explore new ways to assist with rehabilitation of wrist function after stroke. One of the challenges of wrist recovery is the muscle stiffness or high muscle tone that often makes exercise or therapy difficult. Taking this into account, we propose treating the wrist with a combination of a one-time Botox® injection and a 6-week robotic therapy protocol to maximize recovery. Botox® is a drug that is injected directly into a muscle to temporarily relax the muscle. Botox® is commonly used to decrease muscle tone in tight muscles in the stroke population. Robotic therapy provides highly repetitive movement therapy at the wrist. Subjects will be randomized to two groups. Group A will receive the Botox® injection and group B will receive a placebo saline injection. Both groups will receive the same robotics therapy protocol. Both subjects and investigators will be blinded to group assignment. We would like to know if there are trends between groups in a variety of outcome measures depending on what intervention they received. We predict that the treatment group will have better results than the control group on the Fugl Meyer, our primary outcome measure. We hope the results of this pilot study will guide development of a larger clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Stroke

Intervention

Botox®, saline solution

Location

New York Presbyterian Hospital- Weill Cornell campus
New York
New York
United States
10065

Status

Recruiting

Source

New York Presbyterian Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:10-0400

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