Clinical trial NCT02891707: Mobile Device Outcomes-based Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transfemoral Amputation
Transtibial Amputation
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Walter Reed National Military Medical Center
name: Uniformed Services University of the Health Sciences
name: University of Miami
name: Miami VA Healthcare System
First posted: 2016-09-07
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Change in Timed Up and Go (TUG)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Change in Six-minute Walk Test (6MWT)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Change in Amputee Mobility Predictor (AMP)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Change in Bilateral-Amputee Mobility Predictor (BAMP)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Change in Comprehensive High-level Activity Mobility Predictor (CHAMP)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Change in Symmetry of External Work (SEW)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Change in Modified Test of Sensory Integration and Balance (mCTSIB)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
Secondary outcomes:
measure: Charleson Co-Morbidity Index
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Bandura's Self-efficacy Survey
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: New Injury Severity Score
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Patient Reported Outcome Measure Information System (PROMIS)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Prosthetic Limb Users Survey- Mobility (PLUS-M)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Socket Fit Comfort Scale
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Activities-specific balance confidence scale (ABC)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Modified Oswestry Low Back Pain Disability Index (MODI)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Waist Circumference
timeFrame: Baseline
measure: Hip Circumference
timeFrame: Baseline
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center, Uniformed Services Univesrity of the Health Sciences, Center for Rehabilitation Sciences Research
name: Paul F Pasquina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.