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.
Study Type
OBSERVATIONAL
Enrollment
59
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.
Myomo, Inc.
Boston, Massachusetts, United States
Geauga Rehabilitation Engineering, Inc.
Chardon, Ohio, United States
Orthocare Innovations, LLC
Edmonds, Washington, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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Bicep muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
Elbow flex/extend
The number of elbow flex/extend repetitions per day will be recorded.
Time frame: 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.
Time frame: 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".
Time frame: Baseline, 2-weeks post fitting, monthly for 12-months post fitting