Myoelectric Upper Limb Orthosis Use by Persons With Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT03215771|
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Device: MyoPro Motion-G||Not Applicable|
This study has two aims: (1) to evaluate therapeutic and neuroplastic effects of a myoelectric upper limb orthosis and (2) to evaluate the functional effects of a myoelectric upper limb orthosis. The investigators plan to recruit 15 Veterans and non-veterans who have Traumatic Brain Injury (TBI) and upper limb impairment, are over 18 years of age and a minimum of 6 months from injury. The study requires 29 visits over 22 weeks and is divided into four parts: enrollment, orthotic fitting, therapy/training (9 weeks), and home use (9 weeks). Therapeutic and functional benefits will be evaluated every 2 to 3 weeks over 18 weeks using simple, short clinical tests.
Subjects will be enrolled in the study if they meet eligibility criteria assessed at a screening visit. Once enrolled subjects will be custom fit with a MyoPro Motion-G elbow-wrist-hand orthosis following standard clinical procedures. This process requires up to three visits to cast, trial fit and deliver the orthosis. Subjects will then participate 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 will be one session that will combine therapy/training and outcomes evaluation.
Once subjects have completed the therapy/training phase and demonstrated competency with orthosis use, they will start a 9 week home use program during which time they will be contacted by the therapist and seen as needed in the clinic to trouble-shoot any technical issues, monitor for adverse events and/or upgrade their home program. Every third week there will be one session at the clinic for outcomes evaluation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Longitudinal Observation of Myoelectric Upper Limb Orthosis Use Among Veterans With Upper Limb Impairment|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
- Device: MyoPro Motion-G
The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
- Fugl-Meyer Assessment of Motor Recovery (FMA) [ Time Frame: change from baseline Fugl-Meyer Assessment score at 22 weeks ]Evaluation of motor recovery
- Box and Block Test (BBT) [ Time Frame: change from baseline time to complete the Box and Block Test at 22 weeks ]Assesses unilateral gross manual dexterity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215771
|Contact: Svetlana Pundik, MD||216-791-3800 ext email@example.com|
|United States, Ohio|
|Louis Stokes Cleveland VA Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Svetlana Pundik, MD 216-791-3800 ext 3830 firstname.lastname@example.org|