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

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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Sprains

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 Type: Observational
• Enrollment (Anticipated): 265

Contacts and Locations

• Study Contact: Name: Jente Wagemans, MSc; Phone Number: 0032473293079; Email: jente.wagemans@uantwerpen.be
• Study Contact Backup: Name: Dirk Vissers, Prof.; Phone Number: 003232652374; Email: dirk.vissers@uantwerpen.be

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium
      • Recruiting
      • Universitair Ziekenhuis Antwerpen
      • Contact: Jef Michielsen, Professor; Email: jef.michielsen@uza.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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. https://www.jospt.org/doi/10.2519/jospt.2013.0303 - table 1	12 months

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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.	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	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	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

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: University Hospital, Antwerp; University of Ulster; Bern University of Applied Sciences
• Investigators: Principal Investigator: Dirk Vissers, Prof., Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; sports injury; chronic ankle instability; Ankle sprain
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: 1785

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No