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Mobile Device Outcomes-based Rehabilitation Program (MDORP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02891707
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : June 11, 2019
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
Uniformed Services University of the Health Sciences
University of Miami
Miami VA Healthcare System
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

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.

Condition or disease Intervention/treatment Phase
Transfemoral Amputation Transtibial Amputation Device: Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : May 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: 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.
Device: 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.

Active Comparator: 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.
Device: 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.




Primary Outcome Measures :
  1. Change in Timed Up and Go (TUG) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    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.

  2. Change in Six-minute Walk Test (6MWT) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    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.

  3. Change in Amputee Mobility Predictor (AMP) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    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.

  4. Change in Bilateral-Amputee Mobility Predictor (BAMP) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    The BAMP is the AMP adapted for those with bilateral lower limb loss.

  5. Change in Comprehensive High-level Activity Mobility Predictor (CHAMP) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    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.

  6. Change in Symmetry of External Work (SEW) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    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.

  7. Change in Modified Test of Sensory Integration and Balance (mCTSIB) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    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.


Secondary Outcome Measures :
  1. Charleson Co-Morbidity Index [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    Description of Current Medical Conditions

  2. Bandura's Self-efficacy Survey [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    Self-motivation for exercise

  3. New Injury Severity Score [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    History of the musculoskeletal injuries due to the participant's traumatic event will be documented using self-report and past and current medical records from each participant. The injuries will be categorized into anatomical body regions using the Abbreviated Injury Scale (AIS). The New Injury Severity Score (NISS) will be calculated using the AIS for each participant to determine injury severity.

  4. Patient Reported Outcome Measure Information System (PROMIS) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    Physical Function domains will be used to describe the participant's performance of standard activities of daily living, pain intensity, pain severity, fatigue with activities, and sleep disturbance. The PROMIS Mental Health domains will be used to describe the participant's current state of depression, anger, and anxiety with daily activities.

  5. International Physical Activity Questionnaire (IPAQ) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    Physical Activity Questionnaire

  6. Trinity Amputation and Prosthesis Experience Scale-Revised (TAPES-R) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    The TAPES will be administered to the participants with lower limb loss in order to assess psychosocial adjustment, activity restriction, and satisfaction with their current prosthesis. It contains 33 self-reported items; psychosocial adjustment, 15 items; activity restriction, 10 items; and satisfaction, 8 items.

  7. Prosthetic Limb Users Survey- Mobility (PLUS-M) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    The PLUS-M is a self-report measure of mobility designed for prosthetic limb users to assess mobility performing different activities of daily living within the home and community.

  8. Socket Fit Comfort Scale [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    Socket comfort and fit assessment.

  9. Activities-specific balance confidence scale (ABC) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    Measurement of balance confidence.

  10. Modified Oswestry Low Back Pain Disability Index (MODI) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    The MODI is a 10-item questionnaire that will be used to assess current presence and severity of low back pain with different daily activities.

  11. Lower Extremity Functional Scale (LEFS) [ Time Frame: Baseline; Weeks 2,4,6 and 8; Month 3 Follow-Up ]
    The LEFS is a 20- item questionnaire that assesses one's ability to perform activities of daily life, functional mobility, balance, coordination, and range of motion/strength. It is scored on a 4 point scale for each question for a maximum score of 80.

  12. Height [ Time Frame: Baseline ]
    Height in inches of participant will be collected.

  13. Weight [ Time Frame: Baseline ]
    Weight in kilograms of the participant will be collected.

  14. Body Mass Index [ Time Frame: Baseline ]
    Body Mass Index will be calculated for each participant using their height and weight.

  15. Waist Circumference [ Time Frame: Baseline ]
    Waist Circumference in centimeters will be collected from each participant.

  16. Hip Circumference [ Time Frame: Baseline ]
    Hip Circumference in centimeters will be collected from each participant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891707


Locations
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United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Walter Reed National Military Medical Center
Uniformed Services University of the Health Sciences
University of Miami
Miami VA Healthcare System
Investigators
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Principal Investigator: Paul F Pasquina, MD Walter Reed National Military Medical Center, Uniformed Services Univesrity of the Health Sciences, Center for Rehabilitation Sciences Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT02891707    
Other Study ID Numbers: 407406
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No