Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Myomo
- Enrollment
- 59
- Locations
- 3
- Primary Endpoint
- Change from baseline to after intervention in Modified Ashworth Scale: Triceps
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Change from baseline to after intervention in Modified Ashworth Scale: Triceps
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)
Triceps muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Modified Ashworth Scale: Wrist Flexors
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)
Wrist flexors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Modified Ashworth Scale: Wrist Extensors
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)
Wrist extensors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Modified Ashworth Scale: Finger Flexors
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)
Finger flexors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Modified Ashworth Scale: Finger Extensors
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)
Finger extensors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Active Range of Motion: Shoulder Flexion
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)
Active shoulder flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Shoulder Extension
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)
Active shoulder extension range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Shoulder Abduction
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)
Active shoulder abduction range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Shoulder Adduction
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)
Active shoulder adduction range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Elbow Flexion
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)
Active elbow flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Elbow Extension
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)
Active elbow extension range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Wrist Flexion
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)
Active wrist flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Wrist Extension
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)
Active wrist extension range of motion of the affected arm will be measured.
Change from baseline to after intervention in Shoulder Flexion Strength
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)
A manual muscle test (MMT) will be conducted to measure shoulder flexion strength of the affected arm.
Change from baseline to after intervention in Shoulder Abduction Strength
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)
A manual muscle test (MMT) will be conducted to measure shoulder abduction strength of the affected arm.
Change from baseline to after intervention in Bicep Strength
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)
A manual muscle test (MMT) will be conducted to measure bicep strength of the affected arm.
Change from baseline to after intervention in Triceps Strength
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)
A manual muscle test (MMT) will be conducted to measure triceps strength of the affected arm.
Change from baseline to after intervention in Hand Grip Strength
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)
A manual muscle test (MMT) or dynamometer will be used to measure hand grip strength of the affected arm.
Change from baseline to after intervention in Modified Ashworth Scale: Bicep
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)
Bicep muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Passive Range of Motion: Shoulder Flexion
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)
Passive shoulder flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Shoulder Extension
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)
Passive shoulder extension range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Shoulder Abduction
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)
Passive shoulder abduction range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Shoulder Adduction
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)
Passive shoulder adduction range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Elbow Flexion
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)
Passive elbow flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Elbow Extension
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)
Passive elbow extension range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Wrist Flexion
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)
Passive wrist flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Wrist Extension
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)
Passive wrist extension range of motion of the affected arm will be measured.
Functional Timed Tasks Score
Time Frame: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
Participants will complete a pre-identified battery of functional timed tasks that will be scored.
Functional Timed Tasks Time
Time Frame: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
Participants will complete a pre-identified battery of functional timed tasks that will be timed.
Secondary Outcomes
- Elbow flex/extend(2-weeks post fitting, monthly for 12-months post fitting)
- Hand open/close(2-weeks post fitting, monthly for 12-months post fitting)
- Quality of life rating(Baseline, 2-weeks post fitting, monthly for 12-months post fitting)