Outcome Measures Study on an Adult 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 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.

Detailed Description
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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 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.

Official Title
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Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis

Conditions
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Stroke, Brachial Plexus Injury, Spinal Cord Injuries, Neurological Disease

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, 18 years and older Upper limb impairment caused by brachial plexus injury (BPI), any stroke (CVA), spinal cord injury (SCI), or other neurological diagnoses Be medically stable Be in the process of being fit with a MyoPro as a first-time user Has at least trace muscle activation in the elbow and wrist flexors and extensors as measured by a 1/5 on a manual muscle test at targeted joints Has the minimum microvolt EMG threshold to operate the MyoPro, such that the individual can sustain the EMG signals above the threshold for two full seconds (both at elbow and hand) for a minimum of three times within three minutes Has passive range of motion within 5 degrees of terminal range for finger open and close Has passive range of motion within 5 degrees of terminal range for wrist flexion and at least neutral for wrist extension Has passive range of motion within 5 degrees of terminal range for elbow flexion and extension Has at least 30 degrees of active range of motion for shoulder flexion or shoulder abduction Able to support the weight of the MyoPro Able to tolerate functional tasks for 20 min with intermittent rests without excessive fatigue Has intact cognition Able to clearly and verbally communicate in the English language Has a wireless internet connection to participate in telehealth sessions Be attending therapy within four weeks of getting fit and trained with a MyoPro Exclusion Criteria: Has a body weight above 235 lbs Upper limb measurements will not allow for correct fit of the orthosis. Fixed upper limb contractures on affected side Unable to have full passive finger opening when the wrist is in neutral Severe spasticity or tone defined as 2 or higher at the wrist or fingers, or 3 or higher at the elbow on the Modified Ashworth Spasticity Scale Severe shoulder subluxation (greater than one finger with significant pain) or shoulder dislocation Passive shoulder range of motion less than 45 degrees in flexion and abduction Excessive pain, hypersensitivity, or skin issues in the arm(s) that would prevent wearing the MyoPro Severe cognitive or psychiatric problems that might be contraindicated for training and safe MyoPro use Bilateral upper limb impairment Pregnancy Other conditions (e.g. history of neurological disorder other than SCI, BPI, or CVA) or circumstances that would preclude safe and/or effective participation, including severe sensory deficits, skin conditions, and/or other sequelae that may be contraindicated for myoelectric MyoPro use

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Myoelectric Elbow-Wrist-Hand Orthosis|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |