Determining Key Clinical Predictors for Chronic Ankle Instability and Return to Sports With Cost of Illness Analysis: a Prospective Cohort Study
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
- 否
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
Dirk Vissers
Professor
Universiteit Antwerpen
