StrokeNCT04900896
Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis
An observational study of Stroke and Brachial Plexus Injury, run by Myomo at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Brachial Plexus Injury, Spinal Cord Injuries
- What is being tested?
- Myoelectric Elbow-Wrist-Hand Orthosis
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 May 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Myomo, Inc.
Boston, Massachusetts, 02114
Geauga Rehabilitation Engineering, Inc.
Chardon, Ohio, 44024
Orthocare Innovations, LLC
Edmonds, Washington, 98020
About this study
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.
Read the 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.
- Being tested
- Myoelectric Elbow-Wrist-Hand Orthosis
- Medical subject headings
- Stroke, Spinal Cord Injuries, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myoelectric Elbow-Wrist-Hand OrthosisDevice
Also called MyoPro®
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 Shoulder Abduction Strength
A manual muscle test (MMT) will be conducted to measure shoulder abduction strength of the affected arm.
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 Bicep Strength
A manual muscle test (MMT) will be conducted to measure bicep strength of the affected arm.
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 Triceps Strength
A manual muscle test (MMT) will be conducted to measure triceps strength of the affected arm.
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 Hand Grip Strength
A manual muscle test (MMT) or dynamometer will be used to measure hand grip strength of the affected arm.
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 Modified Ashworth Scale: Bicep
Bicep muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
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 Modified Ashworth Scale: Triceps
Triceps muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
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 Modified Ashworth Scale: Wrist Flexors
Wrist flexors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
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 Modified Ashworth Scale: Wrist Extensors
Wrist extensors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
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 Modified Ashworth Scale: Finger Flexors
Finger flexors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
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 Modified Ashworth Scale: Finger Extensors
Finger extensors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
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 Flexion
Active shoulder flexion range of motion of the affected arm will be measured.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Measured: 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.
Measured: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
Secondary outcomes (3)
Elbow flex/extend
The number of elbow flex/extend repetitions per day will be recorded.
Measured: 2-weeks post fitting, monthly for 12-months post fitting
Hand open/close
The number of hand open/close repetitions per day will be recorded.
Measured: 2-weeks post fitting, monthly for 12-months post fitting
Quality of life rating
Participants will be asked to rate their quality of life from "Very Poor" to "Very Good".
Measured: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start11 May 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myomo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orthocare Innovations, LLC, Geauga Rehabilitation Engineering, Inc.
- Responsible party
- Sponsor
- Investigators
- Sarah Chang, PhD, Principal investigator, Orthocare Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900896
- Sponsor's protocol ID
- PRO-001
- Status last verified
- May 2023
- First submitted
- 12 May 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis
- ClinicalTrials.gov ID
- NCT04900896
- Acronym / sponsor ID
- PRO-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (actual)
- Lead sponsor
- MyomoIndustry (pharma, biotech, devices)
- Collaborators
- Orthocare Innovations, LLC, Geauga Rehabilitation Engineering, Inc.
- Study start
- 11 May 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myoelectric Elbow-Wrist-Hand OrthosisAlso: MyoPro®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. | Device | – |
Primary outcome
Change from baseline to after intervention in Shoulder Flexion Strength
Time frame: 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)
A manual muscle test (MMT) will be conducted to measure shoulder flexion strength of the affected arm.
Change from baseline to after intervention in Shoulder Abduction Strength
Time frame: 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)
A manual muscle test (MMT) will be conducted to measure shoulder abduction strength of the affected arm.
Change from baseline to after intervention in Bicep Strength
Time frame: 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)
A manual muscle test (MMT) will be conducted to measure bicep strength of the affected arm.
Change from baseline to after intervention in Triceps Strength
Time frame: 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)
A manual muscle test (MMT) will be conducted to measure triceps strength of the affected arm.
Change from baseline to after intervention in Hand Grip Strength
Time frame: 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)
A manual muscle test (MMT) or dynamometer will be used to measure hand grip strength of the affected arm.
Change from baseline to after intervention in Modified Ashworth Scale: Bicep
Time frame: 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)
Bicep muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Modified Ashworth Scale: Triceps
Time frame: 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)
Triceps muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Modified Ashworth Scale: Wrist Flexors
Time frame: 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)
Wrist flexors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Modified Ashworth Scale: Wrist Extensors
Time frame: 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)
Wrist extensors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Modified Ashworth Scale: Finger Flexors
Time frame: 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)
Finger flexors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Modified Ashworth Scale: Finger Extensors
Time frame: 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)
Finger extensors muscle spasticity of the affected arm will be measured according to the Modified Ashworth Scale.
Change from baseline to after intervention in Active Range of Motion: Shoulder Flexion
Time frame: 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)
Active shoulder flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Shoulder Extension
Time frame: 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)
Active shoulder extension range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Shoulder Abduction
Time frame: 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)
Active shoulder abduction range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Shoulder Adduction
Time frame: 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)
Active shoulder adduction range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Elbow Flexion
Time frame: 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)
Active elbow flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Elbow Extension
Time frame: 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)
Active elbow extension range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Wrist Flexion
Time frame: 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)
Active wrist flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Active Range of Motion: Wrist Extension
Time frame: 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)
Active wrist extension range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Shoulder Flexion
Time frame: 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)
Passive shoulder flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Shoulder Extension
Time frame: 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)
Passive shoulder extension range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Shoulder Abduction
Time frame: 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)
Passive shoulder abduction range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Shoulder Adduction
Time frame: 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)
Passive shoulder adduction range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Elbow Flexion
Time frame: 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)
Passive elbow flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Elbow Extension
Time frame: 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)
Passive elbow extension range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Wrist Flexion
Time frame: 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)
Passive wrist flexion range of motion of the affected arm will be measured.
Change from baseline to after intervention in Passive Range of Motion: Wrist Extension
Time frame: 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)
Passive wrist extension range of motion of the affected arm will be measured.
Functional Timed Tasks Score
Time frame: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
Participants will complete a pre-identified battery of functional timed tasks that will be scored.
Functional Timed Tasks Time
Time frame: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
Participants will complete a pre-identified battery of functional timed tasks that will be timed.
3 secondary outcomes
Elbow flex/extend
Time frame: 2-weeks post fitting, monthly for 12-months post fitting
Hand open/close
Time frame: 2-weeks post fitting, monthly for 12-months post fitting
Quality of life rating
Time frame: Baseline, 2-weeks post fitting, monthly for 12-months post fitting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Chang, PhD principal investigator
Orthocare Innovations, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Brachial Plexus Injury, run by Myomo at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to after intervention in Shoulder Flexion Strength (time frame: 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)). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.