Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis

Conditions
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Cerebrovascular Accidents

Intervention / Treatment
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* Device: Myoelectric Elbow-Wrist-Hand orthosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 18 years. Upper limb impairment caused by any stroke (CVA) Minimum of trace MMT (1/5) in Biceps and/or Triceps Full Passive range of motion in elbow, forearm, wrist, and hand Active shoulder flexion of at least 30 degrees of shoulder abduction of at least 20 degrees Score of at least 20 on the Mini Mental Status Examination. Ability to read and comprehend the English language. Ability to generate consistent, detectable EMG signal from the upper arm and forearm sensor sites with wrist in neutral or flexed positions. Exclusion Criteria: Fixed upper limb contractures on affected side. Subjects with severe spasticity or tone (defined as 3 or more on the Modified Ashworth Scale). Inability to follow three step directions. Severe shoulder subluxation, pain or shoulder dislocation. Passive shoulder range of motion less than 45 degrees in flexion and abduction. Pain or hypersensitivity in the arm(s)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myoelectric Elbow-Wrist-Hand Orthosis<br> | Device: Myoelectric Elbow-Wrist-Hand orthosis<br>* 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.<br>* Other names: MyoPro®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |