Clinical trial NCT05637008: Development of Chronic Ankle Instability After Acute Ankle Sprain
Official title: Determining Key Clinical Predictors for Chronic Ankle Instability and Return to Sports With Cost of Illness Analysis: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankle Sprains
Keywords: Ankle sprain
rehabilitation
sports injury
chronic ankle instability
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University of Ulster
name: Bern University of Applied Sciences
name: University Hospital, Antwerp
First posted: 2022-12-05
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We aim to recruit physically active participants - at least two organized sports sessions per week who sustained an acute ankle sprain.

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.

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

Primary outcomes:
measure: Chronic ankle instability
timeFrame: 12 months
Secondary outcomes:
measure: Ability to return to sports
timeFrame: 12 months
Other outcomes:
measure: Muscle strength
timeFrame: 6 weeks and 12 weeks post injury
measure: Ligament integrity
timeFrame: 7-14 days post injury
measure: The amount of physical activity per day
timeFrame: 14 days, 6 weeks and 12 weeks post-injury
measure: The amount of sleep per night
timeFrame: 14 days, 6 weeks and 12 weeks post-injury
measure: Range of motion
timeFrame: Week 6 and 12 post injury
measure: Ankle proprioception
timeFrame: Week 6 and 12 post injury
measure: Sensorimotor function: functional dynamic balance
timeFrame: Week 6 and 12 post injury
measure: Sensorimotor function: static balance
timeFrame: Week 6 and 12 post injury
measure: Sensorimotor function: dynamic balance
timeFrame: Week 6 and 12 post injury
measure: Performance: t-test
timeFrame: Week 6 and 12 post injury
measure: Performance: drop landing
timeFrame: Week 6 and 12 post injury
measure: Performance: long jump
timeFrame: Week 6 and 12 post injury
measure: Performance: drop vertical jump
timeFrame: Week 6 and 12 post injury
measure: Pain intensity and location
timeFrame: 7-14 days, 6 weeks and 12 weeks post injury
measure: Perceived instability
timeFrame: 7-14 days, 6 weeks, 12 weeks and 12 months post injury
measure: Ankle-specific abilities
timeFrame: 7-14 days, 6 weeks, 12 weeks and 12 months post injury
measure: Illness perception
timeFrame: 7-14 days, 6 weeks, 12 weeks and 12 months post injury
measure: Fear avoidance
timeFrame: 7-14 days, 6 weeks, 12 weeks and 12 months post injury
measure: Fear
timeFrame: 7-14 days, 6 weeks, 12 weeks and 12 months post injury
measure: Life quality
timeFrame: 7-14 days, 6 weeks, 12 weeks and 12 months post injury
measure: Cost of illness
timeFrame: 7-14 days, 6 weeks, 12 weeks and 12 months post injury
measure: Presence/ absence of a recurrent ankle sprain
timeFrame: Every month until 12 months follow-up
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
state: Antwerpen
Study officials:
affiliation: Universiteit Antwerpen
name: Dirk Vissers, Prof.
role: PRINCIPAL_INVESTIGATOR
References: