DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Posted August 17, 2021

Dr. Brent Winslow, Ph.D., Design Interactive, Inc.

Dr. Brent Winslow
Dr. Brent Winslow

Nearly two million people live with limb loss in the United States.1 Restoration of lost function to complete daily activities is a constant challenge, particularly for upper limb loss patients. The loss of an upper limb has devastating impacts to motor and sensory function and can result in reduction of individual independence, quality of life, and employment opportunities. Approximately 50% of upper limb amputees opt for a traditional myoelectric prosthesis, which can provide some upper limb movement control using electromyography (EMG) leads on the residual muscles to control arm and hand movements.2 These myoelectric prostheses still require intensive training to effectively operate, and difficulty with the training process leads to a high rate of prosthesis abandonment.

With the help of a Fiscal Year 2017 Orthotics and Prosthetics Outcomes Research Program (OPORP) Award, Dr. Brent Winslow/Design Interactive, Inc., evaluated the Auto-Diagnostic Adaptive Precision Trainer for Myoelectric Prosthesis Users (ADAPT-MP) to improve training for upper limb amputees on myoelectric prosthesis control. The initial system was developed with Phase I and Phase II Small Business Innovation Research (SBIR) Program funding. The SBIR Program provided additional matching funds to Design Interactive to support further refinement of the ADAPT-MP while being validated under the OPORP award.

The ADAPT-MP system consists of a physical interface and a digital interface. The physical interface includes a wireless wearable muscle-sensing band to display user signals and control games, and the digital interface consists of an Android gaming tablet with a Health Insurance Portability and Accountability Act (HIPAA)-compliant web provider portal, an EMG setup application, and a series of mobile games to improve myoelectric training.

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Following the Food and Drug Administration Center for Devices and Radiological Health guidelines for Applying Human Factors and Usability Engineering to Medical Devices, the ADAPT-MP system underwent extensive testing for patient interaction, usability, and durability. Initial testing found the system to be safe and effective for the intended users and use environments. Feedback from the 7 amputees and 12 able-bodied users in the test group was recorded and used to develop system updates. Specific updates of the ADAPT-MP will be included in the enhanced ADAPT-MP (eADAPT-MP) system. Updates to the system include ensuring the system can run on user mobile devices (Android), improving Bluetooth connectivity, improving graphical assets, and improving current gameplay.

Dr. Winslow and his team at Design Interactive have entered into agreements with outside organizations including the University of South Florida and the James A. Haley Veteran’s Hospital  to host a randomized controlled trial (RCT) to collect additional data. The eADAPT-MP system is being used in the RCT to evaluate the use of novel mobile pre-prosthetic training on compliance and skill outcomes. Usability and durability data will be gathered via patient and provider questionnaires during the pre-prosthetic training phase of the RCT. Compliance and abandonment will also be tracked as the primary outcome metric and skill of prosthesis use as a secondary outcome metric. Other outcome metrics include measuring quality of life, work, and social reintegration as a result of using the device.

Advantages of the eADAPT-MP system include increasing access to engaging tele-rehabilitation tools that mimic the activities of daily life on a system that is fun and engaging. Tele-rehabilitation reduces the burden of travel on the patient, which in turn reduces the burden of scheduling patients for the providers. Enhanced data availability and increased efficiency for the provider is achieved by logging into the system’s web portal, which allows them to provide feedback to patients as they see fit. Furthermore, the system will allow patients to better control their myoelectric prostheses, as well as better upkeep of the devices, driving new insurance qualification standards. The eADAPT-MP system is expected to improve device compliance and skill, translating into better clinical and psychosocial outcomes for Veteran amputees, including return to work and duty, employment, and increased quality of life. It can also reduce healthcare costs in the government and civilian sectors after demonstrating improvement of the cognitive, physical, and neurological functions required to operate a myoelectric prosthesis.

References:

1 Ziegler-Graham K, MacKenzie EJ, Ephraim PL, et al. 2008. Estimating the prevalence of limb loss in the United States: 2005-2050.Archives of Physical Medicine and Rehabilitation89(3):422-429.

2 Dawson MR, Carey JP, and Fahimi F. 2014. Myoelectric training systems. Expert Review of Medical Devices 8(5):581-589.

Publication:

Winslow BD, Ruble M, and Huber, Z. 2018. Mobile, game-based training for myoelectric prosthesis control. Frontiers in Bioengineering and Biotechnology 6(94). doi: 10.3389/fbioe.2018.00094

Link:

Public and Technical Abstracts: Enhanced Autodiagnostic Adaptive Trainer for Myoelectric Prosthesis Users (eADAPT-MP) 


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Last updated Tuesday, August 17, 2021