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| Name | Class |
|---|---|
| MedStar National Rehabilitation Network | OTHER |
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A study will be performed where individuals with chronic stroke will be randomly assigned to receive 2 different dosages of robotic hand therapy. One group will receive 12 sessions of robot-assisted repetitive movement practice in the HEXORR robot over a 4-5 week period. A second group will receive 24 sessions of HEXORR therapy over a 8-10 week period.
The overall goal of the proposed work is to improve hand function after stroke. Adequate hand function is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, involuntary activation of flexors and inability to activate extensors. The rationale for this approach stems from the growing evidence that neuro-rehabilitation after stroke may be enhanced via the application of motor learning strategies within the context of repetitive movement practice. The key therapeutic aspects of these strategies are high repetition, volitional effort, and successful completion of tasks to prevent frustration. While these represent promising therapeutic strategies, they are limited to mildly impaired subjects who already have enough control of finger extension to tolerate high repetitions of grasp/release tasks without succumbing to fatigue and/or frustration. There is a very large population of stroke patients who don't fall into this category and often must rely on compensatory strategies. In these patients, repetitive task practice facilitated by a robotic device may be more effective than unassisted task practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dosage robot therapy | Experimental | 12 sessions of robotic therapy over 4-5 weeks |
|
| hi-dosage robot therapy | Experimental | 24 sessions of robotic therapy over 8-10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEXORR | Device | The subject receives robotic assistance from the HEXORR robot during finger and thumb movements. Several different video games are used to provide feedback of performance and motivate the training. The assistance level is adjusted automatically in some games and manually in other games to enable a target success rate of 67% when playing the games. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fugl-Meyer Test of Motor Function | Measures motor impairment in the upper extremity after stroke | 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Action Research Arm Test | Measures functional limitations of the upper extremity | 6 month follow-up |
| Change in finger extension range of motion (degrees) | Motion capture of finger and thumb movement will be used to assess extension ability in units of degrees. The task will be to open the hand as far as possible from a closed fist. Data from all digits will be averaged to provide a single metric for extension ability of the fingers and thumb. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Lum | The Catholic University of America | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar National Rehabilitation Network | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25667355 | Background | Godfrey SB, Holley RJ, Lum PS. Evaluation of HEXORR Tone Assistance Mode Against Spring Assistance. IEEE Trans Neural Syst Rehabil Eng. 2015 Jul;23(4):610-7. doi: 10.1109/TNSRE.2015.2398933. Epub 2015 Feb 4. | |
| 23900016 | Background | Godfrey SB, Holley RJ, Lum PS. Clinical effects of using HEXORR (Hand Exoskeleton Rehabilitation Robot) for movement therapy in stroke rehabilitation. Am J Phys Med Rehabil. 2013 Nov;92(11):947-58. doi: 10.1097/PHM.0b013e31829e7a07. |
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There is no plan to share data.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009069 | Movement Disorders |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Random assignment to two study groups
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Staff performing clinical evaluations was unaware of the study design.
|
| 6 month follow-up |
| Change in Modified Ashworth Test | Measures hypertonia in the flexors of the fingers, wrist and elbow joints | 6 month follow-up |
| Change in Motor Activity Log | Measures the amount of use of the upper extremity in ADL | 6 month follow-up |
| Change in Grip Strength | Jamar Dynamometer | 6 month follow-up |
| 20667083 | Background | Schabowsky CN, Godfrey SB, Holley RJ, Lum PS. Development and pilot testing of HEXORR: hand EXOskeleton rehabilitation robot. J Neuroeng Rehabil. 2010 Jul 28;7:36. doi: 10.1186/1743-0003-7-36. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |