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临床试验/NCT04302961
NCT04302961已完成早期 1 期

Effects of Gait Retraining With Auditory Feedback on Biomechanics and Ankle Joint Health in Individuals With Chronic Ankle Instability

University of North Carolina, Charlotte2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年10月5日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
28
试验地点
2
主要终点
Changes from baseline in talar cartilage deformation before and after walking

研究概览

简要总结

There is evidence to support individuals with chronic ankle instability (CAI) have altered gait biomechanics which may lead to re-injury and poor patient outcomes. Currently, there are no interventions specifically targeting these abnormal gait biomechanics. Evidence supports the use of an external focus of attention feedback to promote motor learning and retention. The overall purpose of randomized clinical trial is to determine the effects of a 2-week (8 session) gait retraining protocol using an auditory external feedback instrument can (1) alter biomechanics during functional tasks (walking, step-down, lunge, lateral hops, and balance) (2) improve ankle cartilage measures and (3) improve patient-reported outcome measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • History of at least one ankle sprain
  • Index ankle sprain > 12 months prior to study enrollment
  • Most recent ankle sprain > 12 weeks prior to study enrollment
  • Score >10 on the Identification of Functional Ankle Instability (IdFAI) survey.
  • Score <95% on the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and a <85% on the Sport subscales
  • Be physically active by participating in some form of physical activity for at least 20 min per day, three times per week.

排除标准

  • History of ankle surgery
  • History of other musculoskeletal injuries within the past 6 weeks
  • Any condition affecting plantar pressure distribution
  • Neurological or vestibular disorders affecting balance
  • Current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function

结局指标

主要结局

Changes from baseline in talar cartilage deformation before and after walking

时间窗: Immediate post-intervention, 1-week post-intervention

Talar cartilage thickness and cross-sectional area will be measured with an diagnostic ultrasound imaging system

Changes from baseline in self-reported ankle function

时间窗: Immediate post-intervention, 1-week post-intervention

Changes from baseline in self-reported function as measured by the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living and Sport questionnaire. Scores range from 100% (no decrease in function) to 0% (complete loss of function).

Changes from baseline in lower extremity kinetics during walking

时间窗: Immediate post-intervention, 1-week post-intervention

Plantar pressure and center of pressure trajectory measured with an in-shoe plantar pressure system

次要结局

  • Changes from baseline in static balance(Immediate post-intervention, 1-week post-intervention)
  • 2. Changes from baseline in plantar pressure during forward lunges, lateral hops, and a step-down(Immediate post-intervention, 1-week post-intervention)

研究者

发起方
University of North Carolina, Charlotte
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luke Donovan

Assistant Professor

University of North Carolina, Charlotte

研究点 (2)

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