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临床试验/NCT03446131
NCT03446131已完成不适用

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

Mayo Clinic4 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
45
试验地点
4
主要终点
Change in Trunk Position

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Change in Trunk Position

时间窗: 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

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

Trunk Velocity at recovery step completion

次要结局

  • 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)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenton R. Kaufman, Ph.D.

P.E. Director Motion Analysis Laboratory

Mayo Clinic

研究点 (4)

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