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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
Sponsor:
Collaborators:
Louis Stokes VA Medical Center
Myomo Inc.
Information provided by (Responsible Party):
Northwestern University

Brief Summary:
The objective of this study is to document longitudinal outcomes in persons with traumatic brain injury (TBI) using the myoelectric upper limb orthosis with powered elbow and grasp using both patient centric performance and patient reported outcome measures. Longitudinal observation will allow the investigators to detect both the initial therapeutic effects as well as the later functional outcomes of orthosis use. The investigators plan to recruit 15 Veterans and non-veterans who have TBI and upper limb impairment. 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: MyoPro Motion-G Not Applicable

Detailed Description:

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: MyoPro Motion-G
    The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.


Primary Outcome Measures :
  1. Fugl-Meyer Assessment of Motor Recovery (FMA) [ Time Frame: change from baseline Fugl-Meyer Assessment score at 22 weeks ]
    Evaluation of motor recovery

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

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


Contacts
Contact: Svetlana Pundik, MD 216-791-3800 ext 3830 svetlana.pundik@va.gov

Locations
United States, Ohio
Louis Stokes Cleveland VA Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Svetlana Pundik, MD    216-791-3800 ext 3830    svetlana.pundik@va.gov   
Sponsors and Collaborators
Northwestern University
Louis Stokes VA Medical Center
Myomo Inc.

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT03215771     History of Changes
Other Study ID Numbers: W81XWH-16-1-0733
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries