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

NCT04900896 | Unknown FDA Device

• 1 other identifier: PRO-001
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke; Brachial Plexus Injury; Spinal Cord Injuries; Neurological Disease

Outcome Measures

Primary Outcomes (29)

• 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 Outcomes (3)

• 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

Interventions

Myoelectric Elbow-Wrist-Hand Orthosis DEVICE

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.

Also known as: MyoPro®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Myomo: lead
• Orthocare Innovations, LLC: collaborator
• Geauga Rehabilitation Engineering, Inc.: collaborator

Study Sites (3)

Myomo, Inc.

Boston, Massachusetts, 02114, United States

Location

Geauga Rehabilitation Engineering, Inc.

Chardon, Ohio, 44024, United States

Location

Orthocare Innovations, LLC

Edmonds, Washington, 98020, United States

Location

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries; Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sarah Chang, PhD

  Orthocare Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 25, 2021
• Study Start: May 11, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)