Improved Training Program for Fall Prevention of War Fighters

NCT03446131 | Completed

• 2 other identifiers: RRIIW81XWH-15-2-0071
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Limb Injury

Keywords

transfemoral amputation; limb salvage; bilateral amputation; Department of Defense; orthosis; prosthesis; rehabilitation; military treatment facilities; military; injured lower extremity; prevent falls; trauma lower extremity; service members; retired service members; active service members; unilateral lower extremity trauma; limb amputation; limb preservation; preserved limb; trips; slips; transtibial amputation

Outcome Measures

Primary Outcomes (2)

• Change in Trunk Position

  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

  Trunk Velocity at recovery step completion

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

Secondary Outcomes (2)

• Falls

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

• FSST

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Dysvascular disease
• Excessive pain
• Neuromuscular problems preventing the performance of study protocol

Sponsors & Collaborators

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

Study Sites (4)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Center for the Intrepid Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (28)

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  BACKGROUND

• Hijmans JM, Geertzen JH, Dijkstra PU, Postema K. A systematic review of the effects of shoes and other ankle or foot appliances on balance in older people and people with peripheral nervous system disorders. Gait Posture. 2007 Feb;25(2):316-23. doi: 10.1016/j.gaitpost.2006.03.010. Epub 2006 May 9.

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  BACKGROUND

• Acasio JC, Tullos ML, Mahon CE, Khatri BR, Kaufman KR, Dearth CL, Hendershot BD. A single-subject comparison of functional outcomes between lower limb salvage vs. transtibial amputation through sequential participation in a fall-prevention program. Prosthet Orthot Int. 2022 Dec 1;46(6):614-618. doi: 10.1097/PXR.0000000000000156. Epub 2022 Jun 7.

  PMID: 36515906 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.E. Director Motion Analysis Laboratory

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: February 26, 2018
• Study Start: March 12, 2018
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)