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| Name | Class |
|---|---|
| Louis Stokes VA Medical Center | FED |
| Myomo | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyoPro Motion-G | Device | The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35211080 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MyoPro + Motor Based Learning | Subjects received 9 weeks of motor 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. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MyoPro + Motor Based Learning | Subjects received 9 weeks of motor 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. MyoPro Motion-G: The MyoPro Motion-G is a custom-fabricated elbow-wrist-hand myoelectric orthosis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | combined results from 6 TBI and 7 stroke subjects | Posted | Mean | 95% Confidence Interval | score on a scale | Change in Fugl-Meyer Assessment of Motor Recovery for Upper Limb (FMA) from Baseline at Week 18 |
|
18 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MyoPro + Motor Based Learning | Subjects received 9 weeks of motor based therapy in combination with use of MyoPro myoelectric elbow wrist hand orthosis. MyoPro Motion-G: The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stefania Fatone, Principle Investigator | Northwestern University | 3125035717 | s-fatone@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2019 | Jun 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Motor Learning-Based Therapy | Other | 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. |
|
| 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. | 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. | 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. | Change in Craig Handicap Assessment and Rehabilitation Technique (CHART) from Baseline at Week 18 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | combined results from 6 TBI and 7 stroke subjects | Posted | Mean | 95% Confidence Interval | score on a scale | Change in Modified Ashworth Scale from Baseline at Week 18 |
|
|
|
| Secondary | 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. | combined results from 6 TBI and 7 stroke subjects | Posted | Mean | 95% Confidence Interval | score on a scale | Change in Chedoke Arm and Hand Activity Inventory (CAHAI) from Baseline at Week 18 |
|
|
|
| Secondary | 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. | combined results from 6 TBI and 7 stroke subjects | Posted | Mean | 95% Confidence Interval | score on a scale | Change in Orthotic and Prosthetic Users' Survey satisfaction module (OPUSsat) from Baseline at Week 18 |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Change in Craig Handicap Assessment and Rehabilitation Technique (CHART) from Baseline at Week 18 |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |