Mobile Device Outcomes-based Rehabilitation Program

NCT02891707 | Unknown

• 1 other identifier: 407406
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

• Change in Six-minute Walk Test (6MWT)

  The 6MWT has been found to be a measure of overall mobility and physical functioning in the lower limb amputee population and geriatric population. It will be used to provide an overall measure of mobility and musculoskeletal endurance.

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

• Change in Amputee Mobility Predictor (AMP)

  The AMP is a 21 item clinical tool that assesses current functional capability and mobility with a prosthesis when performing basic daily activities. The AMP assesses the ability of an amputee to complete 20 different items that progress in level of difficulty. Higher AMP scores indicate greater prosthetic ambulation capabilities.

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

• Change in Bilateral-Amputee Mobility Predictor (BAMP)

  The BAMP is the AMP adapted for those with bilateral lower limb loss.

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

• Change in Comprehensive High-level Activity Mobility Predictor (CHAMP)

  The CHAMP is a clinical tool that assesses an individual's capabilities in performing high-level mobility and agility activities in multiple planes of motion. It consists of four tests (Single Limb Stance, Edgren Side Step Test, T-Test, and Illinois Agility Test) and generates a total score that indicates greater high-level mobility capabilities.

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

• Change in Symmetry of External Work (SEW)

  The SEW is a biomechanical outcome measure for assessing dynamic movement symmetry during functional activities. SEW values represent the effort undertaken by each lower-limb in moving the body forward during walking. It will be assessed simultaneously with the TUG, AMP, 6MWT, and CHAMP.

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

• Change in Modified Test of Sensory Integration and Balance (mCTSIB)

  The mCTSIB is a test to describe postural control under various sensory conditions. The test requires subjects to maintain balance for 30 seconds in four conditions: firm surface with eyes open, firm surface with eyes closed, standing on foam with eyes open, and standing on foam with eyes closed.

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

Secondary Outcomes (16)

• Charleson Co-Morbidity Index

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

• Bandura's Self-efficacy Survey

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

• New Injury Severity Score

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

• Patient Reported Outcome Measure Information System (PROMIS)

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

• International Physical Activity Questionnaire (IPAQ)

  Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

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

Amputee Group

ACTIVE COMPARATOR

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.

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

Interventions

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.

Amputee Group; Control Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Walter Reed National Military Medical Center: collaborator
• Uniformed Services University of the Health Sciences: collaborator
• University of Miami: collaborator
• Miami VA Healthcare System: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

• 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.

  PMID: 32272105 DERIVED

Study Officials

• Paul F Pasquina, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 7, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: May 1, 2020
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)