Objectives and Rationale for Study The purpose of this research study is to document therapy and function outcomes over time in Veterans using an arm brace with powered elbow motion and hand grasp. Study treatment will consist of upper limb therapy combined with training and use of a myoelectric arm brace. The commercially-available MyoPro Motion-G brace is a non-invasive powered device worn on a partially paralyzed arm to help initiate movement and enhance function. It is designed for use by persons with various neurological problems, including Traumatic Brain Injury (TBI). When the user tries to bend their elbow or grasp objects, sensors in the brace detect the weak muscle electric signal, which activates the motor to move the arm/hand in the desired direction. The user is completely controlling their own arm and hand. The MyoPro Motion-G is a relatively new, commercially-available non-invasive, custom-made arm brace technology and as such clinicians and researchers know very little about how well it works to help improve arm and hand function in people with arm impairments, particularly those caused by TBI. This limits patient access to the brace. Therefore, our proposed study will contribute the evidence needed to support clinical implementation of this brace. Documenting benefits is essential to prescription, provision and reimbursement of the device. Applicability of the Research This research will help patients with arm impairments due to problems such as stroke, TBI, SCI and other neurological problems. For example, TBI is a major challenge in the military and Veteran populations. Since 2000 to June 2015, there have been 36,000 moderate and severe TBI incidents among US military and civilian casualties. Arm and hand problems occur in about 17% of TBI patients and may limit ability to undertake activities of daily living. The MyoPro Motion-G brace is designed to reestablish functional use of an impaired arm by supporting the arm and enabling it to bend and extend through powered amplification of weakened electric signals in the elbow and finger muscles. Patients must have a usable muscle electric signal in their arm and hand, be motivated to use the brace for functional activities, and have the ability to manage the brace. Combining brace training with motor therapy and encouraging greater at home use may result in functional benefits. The challenge of implementing brace-assisted rehabilitation is that there is limited research evidence demonstrating benefits. Research evidence has thus far focused primarily on powered elbow function in persons post-stroke and the benefits of use by persons with TBI or adding powered grasp are unknown. Therefore, this study is a necessary preliminary step exploring the potential benefits of brace-assisted rehabilitation for TBI patients. The total duration of the study is about 29 visits over a period of 22 weeks, which is a long commitment and increases the chances that individuals will discontinue study participation. Functional performance with the brace will be videotaped during some of the testing and the patient’s upper body, head, and neck will be visible in the video tapes which increases the risk of identification. Although a version of this brace has been used since 2007 in both research and clinical practice, it is possible that there may be risks that we cannot predict. There is a possibility that some discomfort or skin irritation may arise while wearing the orthosis, especially if it is donned incorrectly. The device has a lot of built in safety features to ensure that the
|Effective start/end date||9/30/16 → 9/29/20|
- U.S. Army Medical Research and Materiel Command (W81XWH-16-1-0733)
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