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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox® | Experimental | this group will receive an injection of botox in the wrist flexors and forearm pronators |
|
| Saline | Placebo Comparator | This group will receive an injection of saline solution in the same muscle groups as the treatment group (wrist flexors and pronators). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox® | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change scores on Fugl Meyer- Upper Extremity Section | The Fugl Meyer assess quality of movement of the limb at an impairment level. | at baseline and discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change on kinematic analysis | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital- Weill Cornell campus | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19407231 | Background | Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of upper limb botulinum toxin injections on impairment, activity, participation, and quality of life among stroke patients. Stroke. 2009 Jul;40(7):2589-91. doi: 10.1161/STROKEAHA.108.544346. Epub 2009 Apr 30. | |
| 18617860 | Background | Fasoli SE, Fragala-Pinkham M, Hughes R, Krebs HI, Hogan N, Stein J. Robotic therapy and botulinum toxin type A: a novel intervention approach for cerebral palsy. Am J Phys Med Rehabil. 2008 Dec;87(12):1022-5. doi: 10.1097/PHM.0b013e31817fb346. |
| Label | URL |
|---|---|
| click here for to sign up for future stroke studies at NYPH | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| D005457 | Fluoridation |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
|
| saline solution | Other | 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. |
|
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| before injection and one week post injection |
| 19841830 | Background | Frascarelli F, Masia L, Di Rosa G, Petrarca M, Cappa P, Castelli E. Robot-mediated and clinical scales evaluation after upper limb botulinum toxin type A injection in children with hemiplegia. J Rehabil Med. 2009 Nov;41(12):988-94. doi: 10.2340/16501977-0412. |
| 17709993 | Background | Levy CE, Giuffrida C, Richards L, Wu S, Davis S, Nadeau SE. Botulinum toxin a, evidence-based exercise therapy, and constraint-induced movement therapy for upper-limb hemiparesis attributable to stroke: a preliminary study. Am J Phys Med Rehabil. 2007 Sep;86(9):696-706. doi: 10.1097/PHM.0b013e31813e2b4d. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
| D011636 | Public Health Dentistry |
| D004778 | Environment and Public Health |