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



Status:Archived
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2009
End Date:December 2010

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The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke: A Double Blind, Placebo-Controlled Pilot Study


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®.


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.


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