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The objective of this study is to evaluate the functional benefits of a myoelectric Elbow-Wrist-Hand orthosis for persons with upper limb paralysis caused by a cerebrovascular accident (CVA).
The objective of this study is to evaluate the functional gains provided by a myoelectric Elbow-Wrist-Hand orthosis for CVA patients with hemiparesis. The subjects will be fit with the device, provided general training in the operation of the EMG-controlled technology, and then guided through a series of standard clinical outcome measures used routinely as part of stroke rehabilitation medicine. The outcome measures employed in this study include the Fugl-Meyer assessment, the Box and Blocks test, and a battery of common functional tasks and activities. These outcome measures will allow the researchers to approximate the changes in the subjects' ability to successfully perform functional tasks with and without the MyoPro device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myoelectric Elbow-Wrist-Hand Orthosis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myoelectric Elbow-Wrist-Hand orthosis | Device | An arm orthosis that uses myoelectric signals to control the level of mechanical assistance provided to a user's elbow and hand in order to overcome upper limb weakness or paralysis and achieve functional tasks. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment Upper Extremity (FMA-UE) | Assessment of sensorimotor function for the upper extremities (arms) http://www.rehabmeasures.org/lists/rehabmeasures/dispform.aspx?ID=908 | 2 hours |
| Modified Ashworth Scale | Measurement of muscle spasticity due to nervous system injury or disease http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902 | 2 hours |
| Box and Blocks Test | An assessment of unilateral gross manual dexterity, measured by the number 1 inch cubes an individual can move over a barrier in a 60 second time period. http://www.rehabmeasures.org/Lists/RehabMeasures/DispForm.aspx?ID=917 | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Naft, CPO, LPO | Contact | 440-285-5785 | jnaft@greop.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GRE Chardon | Recruiting | Chardon | Ohio | 44024 | United States |
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| 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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|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |