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临床试验/NCT05637008
NCT05637008招募中不适用

Determining Key Clinical Predictors for Chronic Ankle Instability and Return to Sports With Cost of Illness Analysis: a Prospective Cohort Study

Universiteit Antwerpen1 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
265
试验地点
1
主要终点
Chronic ankle instability

研究概览

简要总结

The goal of this observational prospective cohort study is to determine key clinical predictors for chronic ankle instability and return to sports in patients who suffered an acute ankle sprain.

The researchers will evaluate clinical outcome measures and patient reported outcome measures on 3 test moments and at 12 months of follow-up.

详细描述

In this prospective cohort study, 4 different measurement time points will be used: 7-14 days, 6 weeks, 12 weeks and 12 months after the initial ankle sprain event. The researchers will include physically active people that engage in sports regularly, who recently suffered an acute ankle sprain. Recruitment will be done via hospital emergency departments, casualty departments and sports injury clinics, GP's, sports federations and social media.

The researchers will only use outcome measurements that are applicable in clinical practice, and patient reported outcome measures to evaluate the participants. The main outcome of this study is the development of chronic ankle instability, based on published criteria. The researchers aim to determine which clinically applicable outcome measures are key determinants for the development of chronic ankle instability. A secondary outcome is successful return to sports, with the objective to determine key clinically applicable determinants for successful recovery and return to sports.

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

  • 18-55 years old
  • Acute ankle sprain: <7 days
  • Athletes (recreational or professional)
  • Previous ankle sprain >12 months

排除标准

  • Recurrent ankle sprain
  • Ankle fracture
  • Chronic ankle instability
  • High ankle sprain (syndesmosis)
  • A history of ankle or foot operations
  • Other lower limb injuries and/or complaints
  • Severe ocular impairments
  • Any neurological, cardiac, vascular or metabolic disease

结局指标

主要结局

Chronic ankle instability

时间窗: 12 months

Based on the predetermined criteria of the International Ankle Consortium, participants will have developed chronic ankle instability or not. https://www.jospt.org/doi/10.2519/jospt.2013.0303 - table 1

次要结局

  • Ability to return to sports(12 months)

研究者

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

Dirk Vissers

Professor

Universiteit Antwerpen

研究点 (1)

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