Improved Training Program for Fall Prevention of War Fighters (RapidRehab)

January 5, 2021 updated by: Kenton R. Kaufman, Ph.D., Mayo Clinic

Improved Training Program for Fall Prevention of War Fighters With Lower Extremity Trauma

This study will train War Fighters with lower extremity trauma to decrease fall risk.

Study Overview

Status

Completed

Conditions

Detailed Description

Eligible active duty service members, retired or veterans who participated in rehabilitation programs at Department of Defense Advanced Rehabilitation Centers (Walter Reed National Military Medical Center, Center for the Intrepid-San Antonio Military Medical Center and/or the Naval Medical Center San Diego) will be considered for enrollment in this study. This study will look at service members who have undergone transfemoral, transtibial or bilateral lower extremity amputation or limb salvage procedures. Participants will receive fall prevention training on an instrumented treadmill (6, training sessions). Participants will receive three performance assessments:-immediately following completion of the treadmill training and at three and six months following the completion of the training. Post training, twice per month subjects will receive an email containing a follow up fall questionnaire monitoring if they have fallen and the circumstances surrounding their fall. If they do not have access to email, or if a timely response is not received from the email questionnaire which was sent out, subjects will be contacted by phone.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92134
        • Naval Medical Center San Diego
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
    • Texas
      • San Antonio, Texas, United States, 78234
        • Center for the Intrepid Brooke Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study plans to recruit both male and female military beneficiaries with a unilateral or bilateral transtibial or transfemoral amputation or salvaged and preserved limbs. The subjects will be present or past patients in the Naval Medical Center San Diego, C5 Rehabilitation Program, Center for the Intrepid Rehabilitation Program or Walter Reed National Military Medical Center Rehabilitation Program. Subjects will be contacted by the respective site study coordinator and asked to participate in the study.

Description

Inclusion Criteria:

  • Eligible active duty and retired service members and veterans with lower limb trauma
  • Transfemoral amputation, transtibial amputation, bilateral amputation and or limb salvage
  • Participated in conventional rehab at one of the following rehab centers: Walter Reed National Medical Center, Center for the Intrepid Brooke Army Medical Center, Naval Medical Center San Diego
  • Community ambulator
  • Prosthesis / Orthosis use daily
  • Exclusion Criteria:
  • Dysvascular disease
  • Excessive pain
  • Neuromuscular problems preventing the performance of study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Trunk Position
Time Frame: Change from baseline at 0, 3, and 6 months after completing training
Trunk Position (referenced to vertical) at recovery step completion
Change from baseline at 0, 3, and 6 months after completing training
Change in Trunk Velocity
Time Frame: Change from baseline at 0, 3, and 6 months after completing training
Trunk Velocity at recovery step completion
Change from baseline at 0, 3, and 6 months after completing training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls
Time Frame: Change from baseline at 0, 3, and 6 months after completing training
Falls per month reported in the Prosthesis Evaluation Questionnaire - Addendum
Change from baseline at 0, 3, and 6 months after completing training
FSST
Time Frame: Change from baseline at 0, 3, and 6 months after completing training
Four-Square Step Test
Change from baseline at 0, 3, and 6 months after completing training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

University of Illinois at Chicago
United States Naval Medical Center, San Diego
Walter Reed National Military Medical Center
Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2018

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

February 19, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RRII
  • W81XWH-15-2-0071 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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