Status:
UNKNOWN
Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis
Lead Sponsor:
Myomo
Collaborating Sponsors:
Orthocare Innovations, LLC
Geauga Rehabilitation Engineering, Inc.
Conditions:
Stroke
Brachial Plexus Injury
Eligibility:
All Genders
18+ years
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 stu...
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04900896
Start Date
May 11 2021
End Date
December 1 2023
Last Update
May 10 2023
Active Locations (3)
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1
Myomo, Inc.
Boston, Massachusetts, United States, 02114
2
Geauga Rehabilitation Engineering, Inc.
Chardon, Ohio, United States, 44024
3
Orthocare Innovations, LLC
Edmonds, Washington, United States, 98020