Development of Chronic Ankle Instability After Acute Ankle Sprain

Ankle Sprains Clinical Trial

Official title:

Determining Key Clinical Predictors for Chronic Ankle Instability and Return to Sports With Cost of Illness Analysis: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637008
• Other study ID #: 1785
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Universiteit Antwerpen
• Contact: Jente Wagemans, MSc
• Phone: 0032473293079
• Email: jente.wagemans[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

The researchers will evaluate clinical outcome measures and patient reported outcome measures on 3 test moments and at 12 months of follow-up.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 265
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Sprains and Strains

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem	Antwerpen

Sponsors (4)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Bern University of Applied Sciences, University Hospital, Antwerp, University of Ulster

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle strength	Isometric muscle strength of the ankle and hip will be assessed	6 weeks and 12 weeks post injury
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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