Traumatic Brain InjuryNCT03215771
Myoelectric Upper Limb Orthosis Use by Persons With TBI and Stroke
A study testing MyoPro Motion-G and Motor Learning-Based Therapy in people with Traumatic Brain Injury and Stroke, run by Northwestern University at 1 site in United States.
Trial summary
The objective of this study was to document longitudinal outcomes in persons with traumatic brain injury (TBI) or stroke using the myoelectric upper limb orthosis with powered elbow and grasp in conjunction with motor learning-based therapy using both patient centric performance and patient reported outcome measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Stroke
- What is being tested?
- MyoPro Motion-G and Motor Learning-Based Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- over 18 years of age
- minimum 6 months since injury
- elbow, forearm, wrist and hand have full motion with little resistance from muscles when moved by someone else
- some ability to actively move the shoulder
- able to generate consistent and detectable electrical signals from the upper arm and forearm muscles
- able to read and comprehend the English language
Show all 11Show fewer
- able to follow two-stage command
- cognitive abilities sufficient to perform testing and training protocols
- able to tolerate functional tasks for 60 minutes without excessive fatigue
- medically and psychologically stable
- at home support from a family member or care giver if needed
Who cannot join
- elbow, forearm, wrist and hand have less than full motion with high resistance from muscles when moved by someone else
- shoulder instability, pain or dislocation
- unable to safely support the weight of arm with added weight of the device without pain
- less than 12 weeks since botulinum toxin injection in the impaired arm
- new therapies/medications planned during study period
- skin rash or open wound on impaired arm
Show all 10Show fewer
- inability to detect light touch or pain on impaired arm
- involuntary movements of the impaired arm
- pain or hypersensitivity in the impaired arm
- inability to understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Longitudinal Observation of Myoelectric Upper Limb Orthosis Use Among Veterans With Upper Limb Impairment
The objective of this study was to document longitudinal outcomes in persons with traumatic brain injury (TBI) or stroke using the myoelectric upper limb orthosis with powered elbow and grasp in conjunction with motor learning-based therapy using both patient centric performance and patient reported outcome measures. Longitudinal observation allowed the investigators to detect both the initial therapeutic effects as well as the later functional outcomes of orthosis use. The investigators planned to recruit 15 Veterans and non-veterans who had TBI or stroke and upper limb impairment. The study required 29 visits over 22 weeks and was divided into three parts: orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits were evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.
Read the detailed description
This study had two aims: (1) to evaluate therapeutic and neuroplastic effects of a myoelectric upper limb orthosis in conjunction with motor learning-based therapy and (2) to evaluate the functional effects of a myoelectric upper limb orthosis in conjunction with motor learning-based therapy. The investigators planned to recruit 15 Veterans and non-veterans who had Traumatic Brain Injury (TBI) or stroke and upper limb impairment, were over 18 years of age and a minimum of 6 months from injury. The study required 29 visits over 22 weeks and was divided into three parts: orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits were evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.
Subjects were enrolled in the study if they met eligibility criteria assessed at a screening visit. Once enrolled subjects were fit with a custom fabricated MyoPro Motion-G elbow-wrist-hand orthosis following standard clinical procedures. This process required up to three visits to cast, trial fit and deliver the orthosis. Subjects then participated in a standard-of-care motor learning based therapy protocol in conjunction with the PERL ("Push Eat Reach Lift") training program recommended by Myomo, which consists of a 9 week, 18 session training plan. Every second week, there was one session that combined therapy/training and outcomes evaluation.
- Conditions
- Traumatic Brain Injury, Stroke
- Being tested
- MyoPro Motion-G, Motor Learning-Based Therapy
- Medical subject headings
- Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoPro Motion-GDevice
The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
Motor Learning-Based TherapyOther
Motor learning-based (MLB) therapy included movement practice as close to normal as possible, high repetition, progression of challenge, part versus whole task practice, and knowledge of results. Treatment was customized to abilities of each subject and consisted of both MyoPro training and MLB therapy without device. Training with device was progressed using a hierarchy of challenge to increase complexity of movement. MLB therapy without device followed the same hierarchy, incorporating training of movements that could not be accomplished with the device and those that were trained with device. Movement quality was monitored and training practice was incrementally progressed as subject demonstrated improved ability to perform a given task/movement component. Subjects performed a custom home exercise program (HEP) on non-clinic days, increasing repetition as tolerated. At conclusion of in-clinic phase, individuals transitioned to a home phase where they continued to use the HEP.
| Study group | Role | What they receive |
|---|---|---|
| MyoPro + Motor Learning-Based Therapy | Experimental | Subjects received 9 weeks of motor learning-based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. Receives: Device: MyoPro Motion-G; Other: Motor Learning-Based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA)
Evaluation of motor impairment of the upper limb. Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points total) where higher scores represent less arm impairment.
Measured: Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18
Secondary outcomes (4)
Modified Ashworth Scale
Using a 6-point scale, the clinician evaluates resistance to passive movement about a joint with varying degrees of velocity as follows:
0 No increase in muscle tone.
1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension.
1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM.
2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.
3 Considerable increase in muscle tone, passive movement difficult.
4 Affected part(s) rigid in flexion or extension. A lower score represents less resistance to passive movement.
Measured: Change in Modified Ashworth Scale from Baseline at Week 18
Chedoke Arm and Hand Activity Inventory (CAHAI)
Used to assess performance of activities of daily living (ADLs). Measure consists of 13 functional tasks scores and the score for each functional task are summed to compute the total score. Scoring of each task is based on a 7-point scale (1=unable; 7=normal performance; minimum score is 13 points; maximum score is 91 points), where higher scores represent better performance of ADLs.
Measured: Change in Chedoke Arm and Hand Activity Inventory (CAHAI) from Baseline at Week 18
Orthotic and Prosthetic Users' Survey Satisfaction Module (OPUSsat)
An 11-item patient-reported survey that assesses satisfaction with device using a 5-point Likert scale. Satisfaction with device is the sum of the scores (score range: 11-55), where higher scores indicate better satisfaction with device.
Measured: Change in Orthotic and Prosthetic Users' Survey satisfaction module (OPUSsat) from Baseline at Week 18
Craig Handicap Assessment and Rehabilitation Technique (CHART)
A life-role participation survey measuring the level of handicap using objectively observable behaviors in five dimensions: physical, social, cognitive, mobility, and occupation. Survey responses are combined using formulas for each domain. The score in each domain is capped at 100 (total score range: 0-500). Higher scores represent better self-reported participation.
Measured: Change in Craig Handicap Assessment and Rehabilitation Technique (CHART) from Baseline at Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study startDec 2016
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Louis Stokes VA Medical Center, Myomo
- Responsible party
- Principal investigator, Stefania Fatone, PhD, BPO(Hons), Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215771
- Sponsor's protocol ID
- W81XWH-16-1-0733
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2017
- Last updated
- 15 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Pundik S, McCabe J, Skelly M, Salameh A, Naft J, Chen Z, Tatsuoka C, Fatone S. Myoelectric Arm Orthosis in Motor Learning-Based Therapy for Chronic Deficits After Stroke and Traumatic Brain Injury. Front Neurol. 2022 Feb 8;13:791144. doi: 10.3389/fneur.2022.791144. eCollection 2022.
PubMed 35211080
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observation of Myoelectric Upper Limb Orthosis Use Among Veterans With Upper Limb Impairment
- ClinicalTrials.gov ID
- NCT03215771
- Acronym / sponsor ID
- W81XWH-16-1-0733
- Conditions
- Traumatic Brain Injury, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Louis Stokes VA Medical Center, Myomo
- Study start
- Dec 2016 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Posted 14 Jul 2021
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 was to document longitudinal outcomes in persons with traumatic brain injury (TBI) or stroke using the myoelectric upper limb orthosis with powered elbow and grasp in conjunction with motor learning-based therapy using both patient centric performance and patient reported outcome measures. Longitudinal observation allowed the investigators to detect both the initial therapeutic effects as well as the later functional outcomes of orthosis use. The investigators planned to recruit 15 Veterans and non-veterans who had TBI or stroke and upper limb impairment. The study required 29 visits over 22 weeks and was divided into three parts: orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits were evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.
Detailed description
This study had two aims: (1) to evaluate therapeutic and neuroplastic effects of a myoelectric upper limb orthosis in conjunction with motor learning-based therapy and (2) to evaluate the functional effects of a myoelectric upper limb orthosis in conjunction with motor learning-based therapy. The investigators planned to recruit 15 Veterans and non-veterans who had Traumatic Brain Injury (TBI) or stroke and upper limb impairment, were over 18 years of age and a minimum of 6 months from injury. The study required 29 visits over 22 weeks and was divided into three parts: orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits were evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.
Subjects were enrolled in the study if they met eligibility criteria assessed at a screening visit. Once enrolled subjects were fit with a custom fabricated MyoPro Motion-G elbow-wrist-hand orthosis following standard clinical procedures. This process required up to three visits to cast, trial fit and deliver the orthosis. Subjects then participated in a standard-of-care motor learning based therapy protocol in conjunction with the PERL ("Push Eat Reach Lift") training program recommended by Myomo, which consists of a 9 week, 18 session training plan. Every second week, there was one session that combined therapy/training and outcomes evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyoPro + Motor Learning-Based Therapy | Experimental | Device: MyoPro Motion-G, Other: Motor Learning-Based TherapySubjects received 9 weeks of motor learning-based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis, followed by 9 weeks of home use with a customized exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- over 18 years of age
- minimum 6 months since injury
- elbow, forearm, wrist and hand have full motion with little resistance from muscles when moved by someone else
- some ability to actively move the shoulder
- able to generate consistent and detectable electrical signals from the upper arm and forearm muscles
Key exclusion criteria (10 listed)
- elbow, forearm, wrist and hand have less than full motion with high resistance from muscles when moved by someone else
- shoulder instability, pain or dislocation
- unable to safely support the weight of arm with added weight of the device without pain
- less than 12 weeks since botulinum toxin injection in the impaired arm
- new therapies/medications planned during study period
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 |
|---|---|---|
| MyoPro Motion-GThe MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis. | Device | MyoPro + Motor Learning-Based Therapy |
| Motor Learning-Based TherapyMotor learning-based (MLB) therapy included movement practice as close to normal as possible, high repetition, progression of challenge, part versus whole task practice, and knowledge of results. Treatment was customized to abilities of each subject and consisted of both MyoPro training and MLB therapy without device. Training with device was progressed using a hierarchy of challenge to increase complexity of movement. MLB therapy without device followed the same hierarchy, incorporating training of movements that could not be accomplished with the device and those that were trained with device. Movement quality was monitored and training practice was incrementally progressed as subject demonstrated improved ability to perform a given task/movement component. Subjects performed a custom home exercise program (HEP) on non-clinic days, increasing repetition as tolerated. At conclusion of in-clinic phase, individuals transitioned to a home phase where they continued to use the HEP. | Other | MyoPro + Motor Learning-Based Therapy |
Primary outcome
Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA)
Time frame: Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18
Evaluation of motor impairment of the upper limb. Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points total) where higher scores represent less arm impairment.
4 secondary outcomes
Modified Ashworth Scale
Time frame: Change in Modified Ashworth Scale from Baseline at Week 18
Chedoke Arm and Hand Activity Inventory (CAHAI)
Time frame: Change in Chedoke Arm and Hand Activity Inventory (CAHAI) from Baseline at Week 18
Orthotic and Prosthetic Users' Survey Satisfaction Module (OPUSsat)
Time frame: Change in Orthotic and Prosthetic Users' Survey satisfaction module (OPUSsat) from Baseline at Week 18
Craig Handicap Assessment and Rehabilitation Technique (CHART)
Time frame: Change in Craig Handicap Assessment and Rehabilitation Technique (CHART) from Baseline at Week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35211080Pundik S, McCabe J, Skelly M, Salameh A, Naft J, Chen Z, Tatsuoka C, Fatone S. Myoelectric Arm Orthosis in Motor Learning-Based Therapy for Chronic Deficits After Stroke and Traumatic Brain Injury. Front Neurol. 2022 Feb 8;13:791144. doi: 10.3389/fneur.2022.791144. eCollection 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoPro Motion-G and Motor Learning-Based Therapy in people with Traumatic Brain Injury and Stroke, run by Northwestern University at 1 site 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) (time frame: Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03215771, which also lists 1 linked publication.
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 15 Jul 2021.