Northwestern University Feinberg School of Medicine

Northwestern University Prosthetics-Orthotics Center

Longitudinal Observation of Myoelectric Upper Limb Orthosis Use among Veterans with Upper Limb Impairment

Principal Investigator: Stefania Fatone, PhD, BPO(Hons)

Co-Investigators: Samuel Kesner, PhD (Site PI); Jonathon Naft, CPO, Myomo Inc.Svetlana Pundik, MD (Site PI); Ronald G. Reichers II, MD; Daniel Tran, MD, Louis Stokes Cleveland VA Medical Center

Status: In Progress 

Acknowledgment: 
The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work is supported by the Office of Secretary of Defense for Health Affairs, through the Orthotics and Prosthetics Outcomes Research Program, Orthotics Outcomes Research Award under Award No. W81XWH-16-1-0733. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

Introduction

Traumatic Brain Injury (TBI) is a major challenge in the military and Veteran populations. Since 2000 to June 2015, 36,000 moderate and severe TBI incidents have occurred among US military and civilian casualties. In addition, arm and hand problems occur in about 17% of TBI patients and may limit ability to perform Activities of Daily Living (ADL).

To increase upper limb function, Myomo Inc. recently combined powered elbow with powered grasp to create the MyoPro Motion-G myoelectric elbow-wrist-hand orthosis. This commercially-available device is a non-invasive, powered device that is worn on a partially paralyzed arm to help initiate movement and enhance function. It is designed to be used by persons with various neurological problems, including TBI. When the user tries to bend their elbow or grasp objects, sensors in the orthosis detect the weak myoelectric 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 orthosis, and 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 orthosis. In addition, the benefits of adding powered grasp in conjunction with elbow function are unknown and have not been examined directly using patient-centric outcome measures. Combining device training with motor therapy and adding powered grasp may result in further improvements in arm function.

Purpose


The purpose of this research study is to document therapy and function outcomes over time in Veterans who use an arm brace with powered elbow motion and hand grasp. Our study proposes to contribute the evidence needed to support clinical implementation of the MyoPro Motion-G brace. Documenting benefits is essential to the prescription, provision, and reimbursement of the device.

Objective/Specific Aims

The objective of this observational study is to gather longitudinal outcomes in Veterans who use the myoelectric upper limb orthosis with powered elbow and grasp, documenting both patient-centric performance and patient-reported outcome measures. Longitudinal observation will documentat both the therapeutic effects and the functional outcomes of orthosis use.

The Specific Aims are to: (1) evaluate therapeutic effects of the myoelectric upper limb orthosis; and (2) evaluate functional effects of the myoelectric upper limb orthosis.

Study Design

The study team will recruit 15 Veterans from the Cleveland VAMC who have Traumatic Brain Injury (TBI) and upper limb impairment. The study requires 29 visits over 22 weeks and is divided into four parts: enrollment, orthotic fitting, therapy/training, and home use. Therapeutic and functional benefits will be evaluated every 2-3 weeks over 18 weeks using simple, short clinical tests. Within this prospective, observational, longitudinal outcomes study, subjects act as their own controls. 

Myomo project timeline   

Registered as a Clinical Trial

Longitudinal Observation of Myoelectric Upper Limb Orthosis Use among Veterans with Upper Limb Impairment is registered on clinicaltrials.gov as a Clinical Trial (Number NCT03215771).

Registered as a Clinical Trial

Longitudinal Observation of Myoelectric Upper Limb Orthosis Use among Veterans with Upper Limb Impairment is registered on clinicaltrials.gov as a Clinical Trial (Number NCT03215771).

MyoPro Motion W

Dr. Kesner (standing) observes John Rosner (sitting) using the Myomo. 
Dr. Kesner (standing) observes as John Rosner (sitting) uses the MyoPro Motion-G myoelectric elbow-wrist-hand orthosis.