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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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Botox®, saline solution
New York Presbyterian Hospital- Weill Cornell campus
New York Presbyterian Hospital
Published on BioPortfolio: 2014-08-27T03:15:10-0400
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Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).
Any liquid used to replace blood plasma, usually a saline solution, often with serum albumins, dextrans or other preparations. These substances do not enhance the oxygen- carrying capacity of blood, but merely replace the volume. They are also used to treat dehydration.
Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.
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