Mobile Device Outcomes-based Rehabilitation Program

Henry M. Jackson Foundation for the Advancement of Military Medicine150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

150

Conditions

Transfemoral Amputation Transtibial Amputation

Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)DEVICE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

The following inclusion and exclusion criteria will be used to determine eligibility for the veterans with lower limb loss to participate in the study at the Miami VA and SMs at WRNMMC. Inclusion Criteria: * DEERS eligible Veterans/SMs with major unilateral or bilateral lower limb loss at the Symes, Transtibial, Knee Disarticulation, and/or Transfemoral amputation levels * At least 3 months from initial prosthetic fitting and cleared for at home prosthetic use. * Male and Females between 20 - 80 years of age * Determined to be medically stable before participation in the study * Currently have a well-fitting and properly aligned prosthesis * Can independently perform exercises at home * Demonstrate basic proficiency with use of tablet technology Exclusion criteria: * Spinal cord injury or lower limb paralysis * Complete or partial peripheral nerve injury limiting physical performance or increase risk of injury * Cognitively unable to complete the self-report questionnaires or use tablet technology * No valid contact information * Amputation of only toes or upper limb only * Amputation of upper and lower limb * The subject is deemed as living too far away for the physical therapist to conduct home visits. * Evidence of any nerve or brain disorders that affect motion * Unable to speak or understand English * The subject does not have the capacity to provide consent. The following inclusion and exclusion criteria will be used to determine eligibility for the CONTROL subjects to participate in phase I of the study at WRNMMC. Inclusion Criteria: * DEERS Eligible males and females between 20-65 years of age * Determined to be medically stable before participation in the study * No history of upper or lower limb loss Exclusion Criteria: * Evidence of paralysis or other lower limb dysfunction. * Complete or partial peripheral nerve injury limiting physical performance or increase risk of injury * Cognitively unable to follow study instructions * Amputation of upper or lower limb * Unable to walk 100 meters without an assistive device (cane, walker, etc) * History of cardiovascular disease that would limit ambulation 100 meters * Reported symptoms of chest pain or shortness of breath * Evidence of any nerve or brain disorders that affect motion * Unable to speak or understand English * The subject does not have the capacity to provide consent.

Locations (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

Change in Timed Up and Go (TUG)

The TUG is a measure of basic mobility that assesses the time to complete a sit to stand activity from a standard height chair, ambulate less than 10 feet, perform a turning activity, ambulate back to the chair and perform stand to sit activity. It is a measure of mobility and predictor of falls risk.