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OpenTrials
Completed

NCT Number: NCT03446131

Improved Training Program for Fall Prevention of War Fighters

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

Completed

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Naval Medical Center San Diego, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Change in Trunk Velocity

    Time frame: Change from baseline at 0, 3, and 6 months after completing training

    Trunk Velocity at recovery step completion

Secondary outcomes

  1. 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

  2. FSST

    Time frame: Change from baseline at 0, 3, and 6 months after completing training

    Four-Square Step Test

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RapidRehab

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2018
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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