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| Sponsors and Collaborators: |
National Institute of Child Health and Human Development (NICHD) Burke Medical Research Institute |
| Information provided by: | National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00453843 |
Purpose
We will test on persons with chronic impairment due to stroke:
| Condition | Intervention | Phase |
|
Stroke |
Device: rehabilitation robotics Procedure: Movement therapy |
Phase II |
| MedlinePlus related topics: | Rehabilitation |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | The Effect of Proximal and Distal Training on Stroke Recovery |
| Estimated Enrollment: | 160 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | August 2009 |
The Effect of Proximal and Distal Training on Stroke Recovery:
Specific Aim 1. Test whether task specific wrist robotic training improves motor performance among persons with chronic impairment after stroke.
Specific Aim 2. Test whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
Specific Aim 3. Test whether there is generalization across different joints (shoulder & elbow vs wrist).
Specific Aim 4: Test whether there is any interference between training across different joints among persons with chronic impairment after stroke.
Briefly we will invite persons with chronic impairment due to stroke to participate in a study that will train them first on wrist for 6 weeks and then on the shoulder-and-elbow for an additional 6 weeks or vice-versa. A third group will train in alternate days for 12 weeks on the shoulder-and-elbow or the wrist, while a fourth group will be trained on the shoulder, elbow, and wrist on the same day. Outcomes will be measured using standard instruments as well as robot-based measures. We expect that results from this study will provide an objective basis for maximizing this kind of therapy.
Eligibility
| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be included in the study if they meet the following criteria:
Exclusion Criteria:
Patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.
Contacts and Locations| Contact: Avrielle Rykman, O Therapist | (914)597-2220 | arykman@burke.org |
| Contact: Bruce T Volpe, MD | (914)597-2835 | BVOLPE@burke.org |
| United States, New York | |||||
| Burke Medical Research Institute | Recruiting | ||||
| White Plains, New York, United States, 10605 | |||||
| Contact: Avrielle Rykman, O Therapist 914-597-2220 arykman@burke.org | |||||
| Contact: Bruce T Volpe, MD (914)597-2835 BVOLPE@burke.org | |||||
| Principal Investigator: Bruce T Volpe, MD | |||||
| National Institute of Child Health and Human Development (NICHD) |
| Burke Medical Research Institute |
| Principal Investigator: | Hermano I Krebs, PhD | MIT |
More Information
click here for directions 
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| Study ID Numbers: | R01HD045343 |
| First Received: | March 27, 2007 |
| Last Updated: | March 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00453843 |
| Health Authority: | United States: Federal Government |
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