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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04900896
• Other study ID #: PRO-001
• Status: Active, not recruiting
• Start date: May 11, 2021
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: Myomo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brachial Plexus Injury
• Nervous System Diseases
• Neurological Disease
• Spinal Cord Injuries
• Stroke
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Myomo, Inc.	Boston	Massachusetts
United States	Geauga Rehabilitation Engineering, Inc.	Chardon	Ohio
United States	Orthocare Innovations, LLC	Edmonds	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Myomo	Geauga Rehabilitation Engineering, Inc., Orthocare Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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	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
Secondary	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
Secondary	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