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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    100
  • sponsor
    Myomo
Updated on 1 June 2021
stroke
spinal cord
spinal cord disorder

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.

Details
Condition Wounds, strokes, cerebral, neurological disorder, Trauma, Spinal Cord Injury, Brachial Plexus Injury, neurological disease, Spinal Cord Disorders, nervous system disorder, Cerebrovascular accident, nervous system disorders, Myelopathy, Stroke, cerebrovascular accidents, Neurologic Disorders, nervous system disease, Spinal Cord Injuries, disorders of the nervous system, neurologic disorder, neurological disorders
Treatment Myoelectric Elbow-Wrist-Hand orthosis
Clinical Study IdentifierNCT04900896
SponsorMyomo
Last Modified on1 June 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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