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| Name | Class |
|---|---|
| Orthocare Innovations, LLC | INDUSTRY |
| Geauga Rehabilitation Engineering, Inc. | UNKNOWN |
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The objective of this study is to evaluate the therapeutic and functional gains of a myoelectric elbow-wrist-hand orthosis for adult individuals with upper limb impairments using repeated measures studies that combines both gross motion and quantitative function outcome measures.
The objective of this study is to evaluate the therapeutic and functional gains of a myoelectric elbow-wrist-hand orthosis for adult individuals with upper limb impairments using repeated measures studies that combines both gross motion and quantitative function outcome measures.
The primary outcomes of this study will collect data on the participants' therapeutic and functional outcome measures when using the MyoPro over time in their home. Baseline data without the device will be collected prior to receiving the MyoPro. Data with and without the device will then be collected at 2-weeks post fitting and then at 1-month intervals thereafter for 12 months. These outcome measures will enable an understanding of the participants' functional gains with and without the MyoPro and over time with the MyoPro.
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| 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 |
|---|---|---|
| Change from baseline to after intervention in Shoulder Flexion Strength | A manual muscle test (MMT) will be conducted to measure shoulder flexion strength of the affected arm. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Shoulder Abduction Strength | A manual muscle test (MMT) will be conducted to measure shoulder abduction strength of the affected arm. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Bicep Strength | A manual muscle test (MMT) will be conducted to measure bicep strength of the affected arm. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Triceps Strength | A manual muscle test (MMT) will be conducted to measure triceps strength of the affected arm. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Hand Grip Strength | A manual muscle test (MMT) or dynamometer will be used to measure hand grip strength of the affected arm. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Elbow flex/extend | The number of elbow flex/extend repetitions per day will be recorded. | 2-weeks post fitting, monthly for 12-months post fitting |
| Hand open/close | The number of hand open/close repetitions per day will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult with upper limb impairment caused by brachial plexus injury, stroke, or spinal cord injury, or other neurological disease or injury who have no fixed upper limb contractures on the affected side and have been fitted with a myoelectric Elbow-Wrist-Hand orthosis.
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Chang, PhD | Orthocare Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Myomo, Inc. | Boston | Massachusetts | 02114 | United States | ||
| Geauga Rehabilitation Engineering, Inc. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D013119 | Spinal Cord Injuries |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
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| Change from baseline to after intervention in Modified Ashworth Scale: Bicep | Bicep muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Modified Ashworth Scale: Triceps | Triceps muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Modified Ashworth Scale: Wrist Flexors | Wrist flexors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Modified Ashworth Scale: Wrist Extensors | Wrist extensors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Modified Ashworth Scale: Finger Flexors | Finger flexors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Modified Ashworth Scale: Finger Extensors | Finger extensors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Active Range of Motion: Shoulder Flexion | Active shoulder flexion range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Active Range of Motion: Shoulder Extension | Active shoulder extension range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Active Range of Motion: Shoulder Abduction | Active shoulder abduction range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Active Range of Motion: Shoulder Adduction | Active shoulder adduction range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Active Range of Motion: Elbow Flexion | Active elbow flexion range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Active Range of Motion: Elbow Extension | Active elbow extension range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Active Range of Motion: Wrist Flexion | Active wrist flexion range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Active Range of Motion: Wrist Extension | Active wrist extension range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Passive Range of Motion: Shoulder Flexion | Passive shoulder flexion range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Passive Range of Motion: Shoulder Extension | Passive shoulder extension range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Passive Range of Motion: Shoulder Abduction | Passive shoulder abduction range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Passive Range of Motion: Shoulder Adduction | Passive shoulder adduction range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Passive Range of Motion: Elbow Flexion | Passive elbow flexion range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Passive Range of Motion: Elbow Extension | Passive elbow extension range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Passive Range of Motion: Wrist Flexion | Passive wrist flexion range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Change from baseline to after intervention in Passive Range of Motion: Wrist Extension | Passive wrist extension range of motion of the affected arm will be measured. | Once at baseline; once after intervention at midway through therapy (anticipated at 4 weeks); once after intervention at discharge from therapy (anticipated at 8 weeks) |
| Functional Timed Tasks Score | Participants will complete a pre-identified battery of functional timed tasks that will be scored. | Baseline, 2-weeks post fitting, monthly for 12-months post fitting |
| Functional Timed Tasks Time | Participants will complete a pre-identified battery of functional timed tasks that will be timed. | Baseline, 2-weeks post fitting, monthly for 12-months post fitting |
| 2-weeks post fitting, monthly for 12-months post fitting |
| Quality of life rating | Participants will be asked to rate their quality of life from "Very Poor" to "Very Good". | Baseline, 2-weeks post fitting, monthly for 12-months post fitting |
| Chardon |
| Ohio |
| 44024 |
| United States |
| Orthocare Innovations, LLC | Edmonds | Washington | 98020 | United States |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |