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Clinical Trials/NCT05637008
NCT05637008
Recruiting
N/A

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

Universiteit Antwerpen1 site in 1 country265 target enrollmentApril 1, 2023
ConditionsAnkle Sprains

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ankle Sprains
Sponsor
Universiteit Antwerpen
Enrollment
265
Locations
1
Primary Endpoint
Chronic ankle instability
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dirk Vissers

Professor

Universiteit Antwerpen

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Chronic ankle instability

Time Frame: 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

Secondary Outcomes

  • Ability to return to sports(12 months)

Study Sites (1)

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