NCT04900896|UnknownFDA Device
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Sponsor study identifier
observational
59
1 country
3
Study Start
May 11, 2021
Actual (reported)Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 11, 2021
Actual (reported)May 12, 2021
Actual (reported)May 25, 2021
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Myomo, Inc.
Boston, Massachusetts, 02114, United States
Geauga Rehabilitation Engineering, Inc.
Chardon, Ohio, 44024, United States
Orthocare Innovations, LLC
Edmonds, Washington, 98020, United States
Sarah Chang, PhD
Orthocare Innovations, LLC
59 participants (actual enrollment reported by the registry).
First Submitted
May 12, 2021
First Posted
May 25, 2021
Study Start
May 11, 2021
Actual (reported)Adapting MHealth Technology to Improve Patient Activation
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
Contact the study team to confirm eligibility.
Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 10, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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