Clinical trial NCT03446131: Improved Training Program for Fall Prevention of War Fighters
Official title: Improved Training Program for Fall Prevention of War Fighters With Lower Extremity Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: United States Naval Medical Center, San Diego
name: Walter Reed National Military Medical Center
name: Brooke Army Medical Center
name: University of Illinois at Chicago
First posted: 2018-02-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in Trunk Position
timeFrame: Change from baseline at 0, 3, and 6 months after completing training
measure: Change in Trunk Velocity
timeFrame: Change from baseline at 0, 3, and 6 months after completing training
Secondary outcomes:
measure: Falls
timeFrame: Change from baseline at 0, 3, and 6 months after completing training
measure: FSST
timeFrame: Change from baseline at 0, 3, and 6 months after completing training
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: San Antonio
country: United States
facility: Center for the Intrepid Brooke Army Medical Center
state: Texas
Study officials:
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