The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke
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Purpose
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®.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Other: Botox® Other: saline solution |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Impact of Botox® During Robotic Rehabilitation of the Wrist Following Stroke: A Double Blind, Placebo-Controlled Pilot Study |
- Change scores on Fugl Meyer- Upper Extremity Section [ Time Frame: at baseline and discharge ] [ Designated as safety issue: No ]The Fugl Meyer assess quality of movement of the limb at an impairment level.
- Change on kinematic analysis [ Time Frame: before injection and one week post injection ] [ Designated as safety issue: No ]Kinematic information is recorded during administration of the assessment mode of the InMotion 3 wrist robotic device. Movements of the wrist (flexion,extension,ulnar/radial deviation) and forearm (pronation, supination)are recorded for subsequent analysis. Kinematic parameters such as smoothness, position and velocity of movement are examined pre and post injection. The information is extracted from the robotics device and analyzed via computer programs.
| Enrollment: | 12 |
| Study Start Date: | June 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Botox®
this group will receive an injection of botox in the wrist flexors and forearm pronators
|
Other: Botox®
the treatment group will receive a one time injection of Botox® at the wrist flexors and pronators of the affected arm. Each subject will receive a standard dose of 150 units total, 50u each to the flexor carpi radialis and flexor carpi ulnaris, and 25u each for the pronator teres and pronator quadratus muscle groups.
Other Name: botulinum toxin serotype-A
|
|
Placebo Comparator: Saline
This group will receive an injection of saline solution in the same muscle groups as the treatment group (wrist flexors and pronators).
|
Other: saline solution
the control group will receive a one time injection of salt water in the flexor carpi radialis and flexor carpi ulnaris, and the pronator teres and pronator quadratus muscle groups.
Other Name: salt water
|
Detailed Description:
This study will explore new ways to facilitate rehabilitation of wrist function after stroke. One of the challenges of recovery is muscle stiffness or excessive muscle tone that often limits exercise or therapy progress. Taking this into account, the investigators propose treating the wrist and forearm 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. Robotics therapy provides highly repetitive mass practice with visual and haptic feedback.
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. Subjects and investigators will be blinded to group assignment. The investigators would like to know if there are trends between groups in a variety of outcome measures depending on what intervention they received. The investigators predict that the treatment group will have better results than the control group on the Fugl Meyer, our primary outcome measure. The investigators hope the results of this pilot study will guide development of a larger clinical trial.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 6 months post-stroke
- Single stroke
- Ashworth Scale of > 2 but < 4 for wrist flexors and pronators
- Able to follow multiple step directions
- Completed all active occupational therapy
- Motor strength > 1/5 at the wrist extension and supination
- Passive ROM of 0-45 degrees at wrist flexion and extension, 0-20 degrees at radial deviation, 0-20 degrees at ulnar deviation, 0-45 degrees at pronation and supination
- No Botox® injection in the wrist/forearm muscles for at least 12 months
- Naïve to robotics study protocol
Exclusion Criteria:
- Joint contracture and wrist or forearm
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Michael O'Dell, Weill Cornell Medical College/ NewYork Presybterian Hospital |
| ClinicalTrials.gov Identifier: | NCT01088230 History of Changes |
| Other Study ID Numbers: | IRB-0904010371 |
| Study First Received: | March 11, 2010 |
| Last Updated: | April 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York Presbyterian Hospital:
|
hemiparesis robotics stroke |
Botox® rehabilitation wrist spasticity |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013