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

NCT ID: NCT04900896

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

MyoPro®

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthocare Innovations, LLC

INDUSTRY

Sponsor Role: collaborator

Geauga Rehabilitation Engineering, Inc.

UNKNOWN

Sponsor Role: collaborator

Myomo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

Orthocare Innovations, LLC

Locations

Myomo, Inc.

Boston, Massachusetts, United States

Geauga Rehabilitation Engineering, Inc.

Chardon, Ohio, United States

Orthocare Innovations, LLC

Edmonds, Washington, United States

Countries

United States

Other Identifiers

PRO-001

Identifier Type: -

Identifier Source: org_study_id