NCT02891707

Mobile Device Outcomes-based Rehabilitation Program

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This joint research project between the Department of Veterans Affairs (VA) and Department of Defense (DoD) will demonstrate that the implementation of the Mobile Device Outcomes-based Rehabilitation Program (MDORP) will improve the quality of rehabilitative care at a decreased cost to the healthcare system and a reduced burden for service members (SMs) and veterans with lower limb loss. The development of the MDORP will be executed by a multisite translational clinical care team that will use web-based mobile computing devices designed to assess mobility, enable remote prescription of targeted exercise program, and provide continual measureable outcomes to document the continuum of care with the intent of maximizing prosthetic performance while minimizing adverse medical events. The information obtained from this web-based mobile device application will be used by clinicians to promote continuity of care from the DoD and VA facilities nationwide to the community and at home.

Conditions

• Transfemoral Amputation
• Transtibial Amputation

Interventions

Type	Name	Description
DEVICE	Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)	The study will use a novel piece of technology, the ReLOAD, which is a data collector system that uses instrumented insoles, custom, miniature (1"x1") microcontroller with accelerometer, gyroscopes, and geomagnetic sensors connected to a Bluetooth transceiver to collect and transmit gait kinematic data to mobile devices, such as an iPad and iPod. When a person walks or performs a specific activity, the ReLOAD system captures the movement, which can then be stored locally within the mobile device and/or encrypted and sent to a secured central server. This allows the patient or provider to access clinically relevant biomechanical data to help guide rehabilitation.

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-06-01
• Completion: 2020-05-01
• First posted: 2016-09-07
• Last updated: 2019-06-11

Locations

1 site across 1 country: United States