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| Name | Class |
|---|---|
| University of Ulster | OTHER |
| Bern University of Applied Sciences | OTHER |
| University Hospital, Antwerp | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Chronic ankle instability | Based on the predetermined criteria of the International Ankle Consortium, participants will have developed chronic ankle instability or not. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength | Isometric muscle strength of the ankle and hip will be assessed | 6 weeks and 12 weeks post injury |
| Ligament integrity | Ankle 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. |
Inclusion Criteria:
Exclusion Criteria:
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We aim to recruit physically active participants - at least two organized sports sessions per week who sustained an acute ankle sprain.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jente Wagemans, MSc | Contact | 0032473293079 | jente.wagemans@uantwerpen.be | |
| Dirk Vissers, Prof. | Contact | 003232652374 | dirk.vissers@uantwerpen.be |
| Name | Affiliation | Role |
|---|---|---|
| Dirk Vissers, Prof. | Universiteit Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen | Recruiting | Edegem | Antwerpen | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37164478 | Derived | 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. |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D001265 | Athletic Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| 7-14 days post injury |
| The amount of physical activity per day | The participants will wear an activity tracker to asses the amount of physical activity per day (hours) | 14 days, 6 weeks and 12 weeks post-injury |
| The amount of sleep per night | Participants will wear an activity tracker to asses the amount of sleep per night in hours | 14 days, 6 weeks and 12 weeks post-injury |
| Range of motion | Weight-bearing lunge test will be used to assess ankle dorsiflexion. A digital goniometer will be used to assess ankle dorsiflexion, plantar flexion, inversion, eversion | Week 6 and 12 post injury |
| Ankle proprioception | A 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. | Week 6 and 12 post injury |
| Sensorimotor function: functional dynamic balance | Functional 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. | Week 6 and 12 post injury |
| Sensorimotor function: static balance | static 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. | Week 6 and 12 post injury |
| Sensorimotor function: dynamic balance | Single-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. | Week 6 and 12 post injury |
| Performance: t-test | T-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. | Week 6 and 12 post injury |
| Performance: drop landing | -single-leg drop landing: participant will perform a single-leg drop landing from a 30 cm box. The outcome is the ability to perform. | Week 6 and 12 post injury |
| Performance: long jump | - Standing long jump: the participant will perform a single-leg long jump, as far as possible. The jump distance will be the outcome. | Week 6 and 12 post injury |
| Performance: drop vertical jump |
| Week 6 and 12 post injury |
| Pain intensity and location | Pain 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. | 7-14 days, 6 weeks and 12 weeks post injury |
| Perceived instability | Cumberland 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. | 7-14 days, 6 weeks, 12 weeks and 12 months post injury |
| Ankle-specific abilities | Foot 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. | 7-14 days, 6 weeks, 12 weeks and 12 months post injury |
| Illness perception | Illness 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. | 7-14 days, 6 weeks, 12 weeks and 12 months post injury |
| Fear avoidance | Fear 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. | 7-14 days, 6 weeks, 12 weeks and 12 months post injury |
| Fear | The 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. | 7-14 days, 6 weeks, 12 weeks and 12 months post injury |
| Life quality | To 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. | 7-14 days, 6 weeks, 12 weeks and 12 months post injury |
| Cost of illness | Participants 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. | 7-14 days, 6 weeks, 12 weeks and 12 months post injury |
| Presence/ absence of a recurrent ankle sprain | We will ask patients whether they sustained a recurrent ankle sprain by short message service. The outcome is dichotomous: yes/no | Every month until 12 months follow-up |