Improved Training Program for Fall Prevention of War Fighters

Completed

• Conditions: Limb Injury

• Registration Number: NCT03446131
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-26
• Study Start: 2018-03-12
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Trunk Position	Change from baseline at 0, 3, and 6 months after completing training	Trunk Position (referenced to vertical) at recovery step completion
Change in Trunk Velocity	Change from baseline at 0, 3, and 6 months after completing training	Trunk Velocity at recovery step completion

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Center for the Intrepid Brooke Army Medical Center; 🇺🇸 San Antonio, Texas, United States