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临床试验/NCT03849547
NCT03849547已完成不适用

Development of a Smartphone-based System for Training Subjects With Chronic Ankle Instability and Training Effect Evaluation

National Yang Ming Chiao Tung University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Star Excursion Balance Test

研究概览

简要总结

This study aims to verify the training effect of smartphone-based training for chronic ankle instability(CAI) subjects. By randomizing subjects to App training group, clinical training group and control group, the training effect will be compared among groups.

详细描述

Postural control ability may be damaged after ankle sprains. Poor postural control ability is the risk factors of the ankle sprain, forming a vicious circle of recurrent sprains. Proper and early assessment is the key to breaking down the circle. Smartphones have been utilized in the medical field. With built-in sensors, utilizing smartphones as assessment tools can provide quantitative data of postural control performance. This study aims to verify the training effect of smartphone-based training for CAI subjects.

CAI subjects were recruited and randomly assigned to App training group, Home training group and control group, receiving 6 weeks of intervention. Pre-test was conducted before the intervention, and the post-test was conducted after the 6-week intervention. The follow up assessment was conducted 4 weeks after the post-test.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least one ankle sprain history
  • At least 2 times of sprain and feeling unstable
  • Diagnosed as functional ankle instability
  • Full recovered from injury
  • Cumberland Ankle Instability Tool<24
  • Ankle Instability Instrument >5 yes
  • Identification of Functional Ankle Instability >11

排除标准

  • Diagnosis as mechanical instability
  • Neurological deficits
  • Lower extremity injury within the past 6 wk
  • History of lower-extremity surgery
  • Other conditions known to affect balance

结局指标

主要结局

Star Excursion Balance Test

时间窗: 5 minutes

To assess the dynamic balance ability of subjects.

Postural sway measurement

时间窗: 30 seconds

Using smartphone application and force plate to record the postural sway during single leg stance.

次要结局

  • Foot and Ankle Outcome Score(5 minutes)
  • Foot and Ankle Ability Measure-sport subscale(5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-Hsu Sung

Professor

National Yang Ming Chiao Tung University

研究点 (1)

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