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Clinical Trials/NCT03446131
NCT03446131
Completed
N/A

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

Mayo Clinic4 sites in 1 country45 target enrollmentMarch 12, 2018
ConditionsLimb Injury

Overview

Phase
N/A
Intervention
Not specified
Conditions
Limb Injury
Sponsor
Mayo Clinic
Enrollment
45
Locations
4
Primary Endpoint
Change in Trunk Position
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 12, 2018
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kenton R. Kaufman, Ph.D.

P.E. Director Motion Analysis Laboratory

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 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

  • FSST(Change from baseline at 0, 3, and 6 months after completing training)
  • Falls(Change from baseline at 0, 3, and 6 months after completing training)

Study Sites (4)

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