407406

About this trial

Last updated 6 years ago

Study ID

407406

Status

Unknown status

Type

Interventional

Phase

N/A

Placebo

Accepting

20 to 80 Years

All

Trial Timing

Ended 5 years ago

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.

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.

Mobile Device Outcomes-based Rehabilitation Program