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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05637008
Enrollment
265
Registered
2022-12-05
Start date
2023-04-01
Completion date
2025-12-31
Last updated
2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains

Keywords

Ankle sprain, rehabilitation, sports injury, chronic ankle instability

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.

Interventions

None listed

Sponsors

University of Ulster
CollaboratorOTHER
Bern University of Applied Sciences
CollaboratorOTHER
University Hospital, Antwerp
CollaboratorOTHER
Universiteit Antwerpen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Chronic ankle instability12 monthsBased 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

MeasureTime frameDescription
Ability to return to sports12 monthsWhen 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

Other

MeasureTime frameDescription
The amount of physical activity per day14 days, 6 weeks and 12 weeks post-injuryThe participants will wear an activity tracker to asses the amount of physical activity per day (hours)
The amount of sleep per night14 days, 6 weeks and 12 weeks post-injuryParticipants will wear an activity tracker to asses the amount of sleep per night in hours
Range of motionWeek 6 and 12 post injuryWeight-bearing lunge test will be used to assess ankle dorsiflexion. A digital goniometer will be used to assess ankle dorsiflexion, plantar flexion, inversion, eversion
Ankle proprioceptionWeek 6 and 12 post injuryA fixed handheld dynamometer (HHD) will be used to assess force sense as a measure of proprioception. To evaluate joint position sense as a measure proprioception, the slope-box test will be used.
Sensorimotor function: functional dynamic balanceWeek 6 and 12 post injuryFunctional dynamic balance: y-balance test Participant will reach as far as possible in three directions - anterior, posterolateral, posteromedial. The reaching distance will be calculated in proportion to the lower limb length and be reported in percentage.
Sensorimotor function: static balanceWeek 6 and 12 post injurystatic balance by single-leg stance: foot-lift test Participants will stand 30 seconds on one leg, with eyes closed. The amount of errors (deviations, foot lifts, ground touches from other foot) will be the outcome.
Sensorimotor function: dynamic balanceWeek 6 and 12 post injurySingle-leg dynamic balance: side-hop test Participants will hop 10 times sideways medially and laterally over a 30-cm distance as fast as possible. Time to perform the 10 hops back and forth is the outcome.
Performance: t-testWeek 6 and 12 post injuryT-test for quickness: Participants will have to take place at an indicated starting line. On the signal, they will have to run forwards to the centre cone, sidestep 5 meters to the right cone, sidestep 10 meters to the far left cone and then sidestep back 5 meters to the centre cone. Conclusively, participants have to run backwards back to the starting line. This test is performed as quickly as possible.
Performance: drop landingWeek 6 and 12 post injury-single-leg drop landing: participant will perform a single-leg drop landing from a 30 cm box. The outcome is the ability to perform.
Performance: long jumpWeek 6 and 12 post injury\- Standing long jump: the participant will perform a single-leg long jump, as far as possible. The jump distance will be the outcome.
Muscle strength6 weeks and 12 weeks post injuryIsometric muscle strength of the ankle and hip will be assessed
Pain intensity and location7-14 days, 6 weeks and 12 weeks post injuryPain will be assessed using a numeric pain rating scale for pain severity from 0-10. 0 indicates no pain, 10 indicates unbearable pain. Additionally we will ask participants to show the location of their pain.
Perceived instability7-14 days, 6 weeks, 12 weeks and 12 months post injuryCumberland Ankle instability Tool: this assessment tool provides a scale up to 30 points. The higher the score, the worse the perceived instability of the participant.
Ankle-specific abilities7-14 days, 6 weeks, 12 weeks and 12 months post injuryFoot and ankle ability measure - questionnaire: The short version of the Foot and Ankle ability measure (Quick-FAAM) will be used to evaluate region-specific functional abilities. This questionnaire contains twelve items scored across a 5-point Likert scale. High score indicates the inability to perform the evaluated task.
Illness perception7-14 days, 6 weeks, 12 weeks and 12 months post injuryIllness perception questionnaire: The Illness perception questionnaire (IPQ) quantitatively evaluates the five components of illness representation: illness identity, cause, timeline, consequences and management on a 10-point Lickert scale. The higher the score (10), the worse the participant perceives the injury.
Fear avoidance7-14 days, 6 weeks, 12 weeks and 12 months post injuryFear avoidance believes pertinent to physical activities and work will be quantitatively evaluated by the fear avoidance beliefs questionnaire on a 7-point Lickert scale (0-6). 0 = disagrees with statement; 6= agrees with statement. There are 16 statements.
Fear7-14 days, 6 weeks, 12 weeks and 12 months post injuryThe 11-questions version of Tampa Scale for Kinesiophobia (TSK-11) will be utilized to assess pain-related fear of physical movement and activity. Participants have to provide their opinion regarding 11 statements: 1. totally disagree, 2. disagree for some part, 3. agree for some part, 4. totally agree.
Life quality7-14 days, 6 weeks, 12 weeks and 12 months post injuryTo assesses quality of life by addressing five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, the EQ-5D-5L questionnaire will be employed. Each domain is scored across a 5-point Likert scale: 0= no problems, 1= slight problems, 2= moderate problems, 3= severe problems and 4= extreme problems.
Cost of illness7-14 days, 6 weeks, 12 weeks and 12 months post injuryParticipants will be asked to share both direct and indirect costs related to the ankle sprain during the full course of the follow-up. Participants who incur a recurrent ankle sprain will be asked about both costs all over again.
Presence/ absence of a recurrent ankle sprainEvery month until 12 months follow-upWe will ask patients whether they sustained a recurrent ankle sprain by short message service. The outcome is dichotomous: yes/no
Performance: drop vertical jumpWeek 6 and 12 post injury* Drop vertical jump: Participant will perform a drop off a 30 cm box, with a subsequent jump as high as possible. Outcomes of this test are jump height, stiffness, reactive strength index and contact time * T-test for quickness
Ligament integrity7-14 days post injuryAnkle sprain severity grade (grade 1: ligament fibre stretch; Grade 2: partial ligament tear; grade 3: complete ligament rupture) will be evaluated using a portable ultrasound, manual ligament stress testing, patient's perception of the ankle sprain severity, and bruising and palpation.

Countries

Belgium

Contacts

Primary ContactJente Wagemans, MSc
jente.wagemans@uantwerpen.be0032473293079
Backup ContactDirk Vissers, Prof.
dirk.vissers@uantwerpen.be003232652374

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026