An observational study in Limb Injury, sponsored by Mayo Clinic. Completed at 4 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-01-07.
Sponsored by Mayo Clinic · Observational
This study will train War Fighters with lower extremity trauma to decrease fall risk.
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.
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.
Change in Trunk Position
Trunk Position (referenced to vertical) at recovery step completion
Time frame: Change from baseline at 0, 3, and 6 months after completing training
Change in Trunk Velocity
Trunk Velocity at recovery step completion
Time frame: Change from baseline at 0, 3, and 6 months after completing training
Falls
Falls per month reported in the Prosthesis Evaluation Questionnaire - Addendum
Time frame: Change from baseline at 0, 3, and 6 months after completing training
FSST
Four-Square Step Test
Time frame: Change from baseline at 0, 3, and 6 months after completing training
Plan to share: No
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Mayo Clinic