Mobile Device Outcomes-based Rehabilitation Program (MDORP)

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status: Unknown

Conditions: Transtibial Amputation; Transfemoral Amputation

Treatments: Device: Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02891707

407406

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Control Group

Active Comparator group

Description:

The investigators will recruit 20 healthy subjects at Walter Reed National Military Medical Center (WRNMMC) with the goal of consenting and enrolling 15 healthy subjects to assess the reliability and validity the wearable Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD) system.

Treatment:

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

Amputee Group

Active Comparator group

Description:

The investigators will recruit a total of 130 subjects (65 at WRNMMC and 65 at the Miami VA) with the goal of consenting and enrolling 100 subjects (50 and WRNMMC and 50 at the Miami VA) with lower limb amputation to utilize the ReLOAD system.

Treatment:

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