Clinical trial NCT04900896: Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis
Official title: Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Brachial Plexus Injury
Spinal Cord Injuries
Neurological Disease
Lead sponsor: Myomo
Sponsor class: INDUSTRY
Collaborators: name: Orthocare Innovations, LLC
name: Geauga Rehabilitation Engineering, Inc.
First posted: 2021-05-25
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change from baseline to after intervention in Shoulder Flexion Strength
timeFrame: 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)
measure: Change from baseline to after intervention in Shoulder Abduction Strength
timeFrame: 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)
measure: Change from baseline to after intervention in Bicep Strength
timeFrame: 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)
measure: Change from baseline to after intervention in Triceps Strength
timeFrame: 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)
measure: Change from baseline to after intervention in Hand Grip Strength
timeFrame: 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)
measure: Change from baseline to after intervention in Modified Ashworth Scale: Bicep
timeFrame: 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)
measure: Change from baseline to after intervention in Modified Ashworth Scale: Triceps
timeFrame: 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)
measure: Change from baseline to after intervention in Modified Ashworth Scale: Wrist Flexors
timeFrame: 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)
measure: Change from baseline to after intervention in Modified Ashworth Scale: Wrist Extensors
timeFrame: 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)
measure: Change from baseline to after intervention in Modified Ashworth Scale: Finger Flexors
timeFrame: 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)
measure: Change from baseline to after intervention in Modified Ashworth Scale: Finger Extensors
timeFrame: 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)
measure: Change from baseline to after intervention in Active Range of Motion: Shoulder Flexion
timeFrame: 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)
measure: Change from baseline to after intervention in Active Range of Motion: Shoulder Extension
timeFrame: 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)
measure: Change from baseline to after intervention in Active Range of Motion: Shoulder Abduction
timeFrame: 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)
measure: Change from baseline to after intervention in Active Range of Motion: Shoulder Adduction
timeFrame: 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)
measure: Change from baseline to after intervention in Active Range of Motion: Elbow Flexion
timeFrame: 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)
measure: Change from baseline to after intervention in Active Range of Motion: Elbow Extension
timeFrame: 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)
measure: Change from baseline to after intervention in Active Range of Motion: Wrist Flexion
timeFrame: 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)
measure: Change from baseline to after intervention in Active Range of Motion: Wrist Extension
timeFrame: 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)
measure: Change from baseline to after intervention in Passive Range of Motion: Shoulder Flexion
timeFrame: 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)
measure: Change from baseline to after intervention in Passive Range of Motion: Shoulder Extension
timeFrame: 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)
measure: Change from baseline to after intervention in Passive Range of Motion: Shoulder Abduction
timeFrame: 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)
measure: Change from baseline to after intervention in Passive Range of Motion: Shoulder Adduction
timeFrame: 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)
measure: Change from baseline to after intervention in Passive Range of Motion: Elbow Flexion
timeFrame: 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)
measure: Change from baseline to after intervention in Passive Range of Motion: Elbow Extension
timeFrame: 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)
measure: Change from baseline to after intervention in Passive Range of Motion: Wrist Flexion
timeFrame: 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)
measure: Change from baseline to after intervention in Passive Range of Motion: Wrist Extension
timeFrame: 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)
measure: Functional Timed Tasks Score
timeFrame: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
measure: Functional Timed Tasks Time
timeFrame: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
Secondary outcomes:
measure: Elbow flex/extend
timeFrame: 2-weeks post fitting, monthly for 12-months post fitting
measure: Hand open/close
timeFrame: 2-weeks post fitting, monthly for 12-months post fitting
measure: Quality of life rating
timeFrame: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
Other outcomes:
Locations:
city: Boston
country: United States
facility: Myomo, Inc.
state: Massachusetts
city: Chardon
country: United States
facility: Geauga Rehabilitation Engineering, Inc.
state: Ohio
city: Edmonds
country: United States
facility: Orthocare Innovations, LLC
state: Washington
Study officials:
affiliation: Orthocare Innovations, LLC
name: Sarah Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: