Mobile Device Outcomes-based Rehabilitation Program

NCT ID: NCT02891707

Last Updated: 2019-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-05-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Amputee Group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• 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.

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

Miami VA Healthcare System

FED

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul F Pasquina, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center, Uniformed Services Univesrity of the Health Sciences, Center for Rehabilitation Sciences Research

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

References

Gaunaurd I, Kristal A, Horn A, Krueger C, Muro O, Rosenberg A, Gruben K, Kirk-Sanchez N, Pasquina P, Gailey R. The Utility of the 2-Minute Walk Test as a Measure of Mobility in People With Lower Limb Amputation. Arch Phys Med Rehabil. 2020 Jul;101(7):1183-1189. doi: 10.1016/j.apmr.2020.03.007. Epub 2020 Apr 6.

Reference Type: DERIVED

PMID: 32272105 (View on PubMed)

Other Identifiers

407406

Identifier Type: -

Identifier Source: org_study_id