Development of Chronic Ankle Instability After Acute Ankle Sprain
Determining Key Clinical Predictors for Chronic Ankle Instability and Return to Sports With Cost of Illness Analysis: a Prospective Cohort Study
1 other identifier
observational
265
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 11, 2023
May 1, 2023
2.8 years
October 19, 2022
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chronic ankle instability
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
12 months
Secondary Outcomes (1)
Ability to return to sports
12 months
Other Outcomes (22)
Muscle strength
6 weeks and 12 weeks post injury
Ligament integrity
7-14 days post injury
The amount of physical activity per day
14 days, 6 weeks and 12 weeks post-injury
- +19 more other outcomes
Eligibility Criteria
We aim to recruit physically active participants - at least two organized sports sessions per week who sustained an acute ankle sprain.
You may qualify if:
- years old
- Acute ankle sprain: \<7 days
- Athletes (recreational or professional)
- Previous ankle sprain \>12 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universiteit Antwerpenlead
- University of Ulstercollaborator
- Bern University of Applied Sciencescollaborator
- University Hospital, Antwerpcollaborator
Study Sites (1)
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium
Related Publications (1)
Wagemans J, Taeymans J, Kuppens K, Baur H, Bleakley C, Vissers D. Determining key clinical predictors for chronic ankle instability and return to sports with cost of illness analysis: protocol of a prospective cohort study. BMJ Open. 2023 May 10;13(5):e069867. doi: 10.1136/bmjopen-2022-069867.
PMID: 37164478DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk Vissers, Prof.
Universiteit Antwerpen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 19, 2022
First Posted
December 5, 2022
Study Start
April 1, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
May 11, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share