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| ID | Type | Description | Link |
|---|---|---|---|
| R44HD041805 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group.
Many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. The control group will receive device treatment for 3 months following their final evaluation. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Hand Mentor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand Mentor | Device | Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test | Initial, 6 wks, 12 wks, 16 wks, 52 wks |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with recommended use | 6 wks, 12 wks | |
| Fugl-Meyer Test | Initial, 6 wks, 12 wks, 16 wks, 52 wks | |
| Stoke Impact Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James B Koeneman, Ph.D. | Kinetic Muscles, Inc. | Principal Investigator |
| Steven L Wolf, Ph.D., PT | Emory University Medical School | Study Director |
| Richard Herman, MD | Banner Good Samaritan Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University, College of Nursing & Healthcare Innovation | Phoenix | Arizona | 85004 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17012642 | Background | Frick EM, Alberts JL. Combined use of repetitive task practice and an assistive robotic device in a patient with subacute stroke. Phys Ther. 2006 Oct;86(10):1378-86. doi: 10.2522/ptj.20050149. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 23, 2013 | |
| Reset | Jul 3, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 23, 2013 | Jul 3, 2013 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Initial, 6 wks, 12 wks, 16 wks, 52 wks |
| Emory University |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |