Ankle SprainsNCT05637008
Development of Chronic Ankle Instability After Acute Ankle Sprain
An observational study of Ankle Sprains, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Ankle Sprains
- How many people
- 265 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: We aim to recruit physically active participants - at least two organized sports sessions per week who sustained an acute ankle sprain.
Who may be able to join
- 18-55 years old
- Acute ankle sprain: <7 days
- Athletes (recreational or professional)
- Previous ankle sprain >12 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen
Jef Michielsen, Professor, jef.michielsen@uza.be
About this study
Official title: Determining Key Clinical Predictors for Chronic Ankle Instability and Return to Sports With Cost of Illness Analysis: a Prospective Cohort Study
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.
Read the 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.
- Conditions
- Ankle Sprains
- Keywords
- Ankle sprain, rehabilitation, sports injury, chronic ankle instability
- Medical subject headings
- Ankle Injuries, Athletic Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Ability to return to sports
When participants are able to return to full participation at the same level prior to the injury, participants will have achieved successful return to sports. This outcome will be documented in a dichotomous manner: yes/no
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster, Bern University of Applied Sciences, University Hospital, Antwerp
- Responsible party
- Principal investigator, Dirk Vissers, Universiteit Antwerpen
- Investigators
- Dirk Vissers, Prof., Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637008
- Sponsor's protocol ID
- 1785
- Status last verified
- May 2023
- First submitted
- 19 Oct 2022
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37164478
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Key Clinical Predictors for Chronic Ankle Instability and Return to Sports With Cost of Illness Analysis: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05637008
- Acronym / sponsor ID
- 1785
- Conditions
- Ankle Sprains
- Keywords
- Ankle sprain, rehabilitation, sports injury, chronic ankle instability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University of Ulster, Bern University of Applied Sciences, University Hospital, Antwerp
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We aim to recruit physically active participants - at least two organized sports sessions per week who sustained an acute ankle sprain.
Key inclusion criteria (4 listed)
- 18-55 years old
- Acute ankle sprain: <7 days
- Athletes (recreational or professional)
- Previous ankle sprain >12 months
Key exclusion criteria (8 listed)
- Recurrent ankle sprain
- Ankle fracture
- Chronic ankle instability
- High ankle sprain (syndesmosis)
- A history of ankle or foot operations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Ability to return to sports
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 37164478Wagemans 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.
- Individual participant dataSharing planned: No
Related trials for Ankle Sprains
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Vissers, Prof. principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Sprains, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jente Wagemans, MSc (0032473293079, jente.wagemans@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic ankle instability (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.