Ankle DislocationCAIDiagNCT03818438
Chronic Ankle Instability Diagnostic Tests Determining Underlying Deficits
An observational study of Ankle Dislocation and Chronic Ankle Instability, run by University Hospital, Lille at 1 site in France.
Trial summary
Chronic ankle instability is a common condition in the active adult population and characterized by the occurrence of repeated giving way and/or recurrent ankle sprains. Multiple underlying deficits have been proposed, among which ankle muscle strength deficits, proprioception deficits, ( static and dynamic balance… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Dislocation, Chronic Ankle Instability
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2019to 25 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults (18-45 yrs) living in the northern part of France close to or in Lille, Saint-Omer and Amiens
Who may be able to join
- Case subject : at least one initial lateral ankle sprain more than 12 months before inclusion
- Case subject : at least one residual symptom among (1) giving way, (2) sensation of instability, (3) recurrent ankle sprain. This item is confirmed by a score inferior than 24 on the Chronic Ankle Instability Tool (CAIT)
- Case subject : Impact on activities of daily living and sport, confirmed by a score of less than 90% on the Foot and Ankle Ability Measure (FAAM) and less than 80% on FAAM-- - -- Control subject : matched by age and sex to case subjects
Who cannot join
- Surgery of one of the lower limbs less than 3 years ago
- Presence of heavy pain (EVA > 8) regardless of its origin
- Acute lateral ankle sprain less than 4 months before inclusion
- Neurological disorders of any kind
- Medical treatment (drugs) interfering with muscle tone, balance and proprioception disorders
- Pregnant or breastfeeding women
- Body mass index > 30
- Bilateral chronic ankle instability
Trial locations and contacts
1 site in 1 country.
France1 site
CH Saint-Omer, institut audomarois de la chirurgie orthopédique et du sport
Saint-Omer
About this study
Official title: Biomechanical Analysis, Complementary Examinations and Rehabilitative Management of Chronic Ankle Instability
Chronic ankle instability is a common condition in the active adult population and characterized by the occurrence of repeated giving way and/or recurrent ankle sprains. Multiple underlying deficits have been proposed, among which ankle muscle strength deficits, proprioception deficits, ( static and dynamic balance disorders, and articular laxity. Unfortunately, no consensus exists on which clinical tests should be realized to determine if one of these underlying deficits is predominant and as a result could guide the rehabilitation process. The study hypothesis is that people with chronic ankle instability might be heterogenous and could be divided in different subgroups as a function of underlying deficits. Therefore, this study aims to evaluate the capacity of different clinical tests to differentiate people with chronic ankle instability from healthy people as well as between each other.
- Conditions
- Ankle Dislocation, Chronic Ankle Instability
- Keywords
- Chronic instability, Strength, Proprioception, Rehabilitation, Ankle, Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case subjects adult patients with chronic ankle instability | Male or female subjects aged 18-45, presenting : * at least one acute lateral ankle sprain (i.e. initial ankle sprain more than 12 months before inclusion), * at least one residual symptom (giving way OR sensation of instability OR recurrent ankle sprain), confirmed by a score < 24 on the Chronic Ankle Instability Tool (CAIT) * Impact on activities of daily living and sport, score < 90% on Foot and Ankle Ability Measure (FAAM) and < 80% on FAAM-sport Case subjects are free of any other lower extremity pathologies or pain Subjects presenting bilateral chronic ankle instability are excluded | |
| Healthy subjects | Male or female subjects aged 18-45 (matched with case Healthy subjects), without any lower extremity pathologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance tests
Static balance tests ( DLS and SLS (both ankles tested) ; Stabilometry) are composite measure
- Centre of Pressure (COP) displacement (mm) ;
- COP velocity (mm/s)
- COP area (mm²)
- COP time-to-boundary (TTB) (s)
- Number of foot lifts (integer)
Measured: Baseline
the Star Excursion Balance Test (SEBT)
Dynamic balance test : SEBT (both ankles tested) : are composite measure
- Distance reached in anterior direction (% leg length)
- Distance reached in posteromedial direction (% leg length)
- Distance reached in posterolateral direction (% leg length)
- Time used to reach (s)
- COP displacement (mm)
- COP velocity (s)
- COP area (mm²)
- COP time-to-boundary (TTB) (s)
Measured: Baseline
Hop tests
Hop tests (both ankles tested) : SLHD et SH ; are composite measure
- Distance reached (m)
- Max inversion angle ankle joint (°)
- Max internal rotation angle ankle joint (°)
- Max vertical Ground Reaction Force (GRF) at landing (N)
- Max lateral GRF (N)
- Time used to complete 10 hops (s)
Measured: Baseline
Strength tests (both ankles tested)
Isokinetic strength tests (both ankles tested) :
- Plantar flexor peak torque (Nm)
- Dorsiflexor peak torque (Nm)
- Inversion peak torque (Nm)
- Eversion Peak torque (Nm)
Measured: Baseline
Secondary outcomes (1)
Intra-class correlation coefficients (reproducibility test-retest)
Intra-class correlation coefficients (reproducibility test-retest) calculated on the subset of the parameters identified by the main analysis.
Recyclability of the functional clinical tests : Normality testing /Sample comparison
Measured: Baseline and 1-4 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start24 Oct 2019
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Why it stopped: insufficiency inclusion; covid crisis ; sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Alexandre Arnould, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818438
- Sponsor's protocol ID
- 2017_09
- Other IDs
- 2018-A00102-53
- Acronym
- CAIDiag
- Status last verified
- May 2022
- First submitted
- 9 Jan 2019
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Analysis, Complementary Examinations and Rehabilitative Management of Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03818438
- Acronym / sponsor ID
- CAIDiag / 2017_09
- Conditions
- Ankle Dislocation, Chronic Ankle Instability
- Keywords
- Chronic instability, Strength, Proprioception, Rehabilitation, Ankle, Balance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficiency inclusion; covid crisis ; sponsor decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic ankle instability is a common condition in the active adult population and characterized by the occurrence of repeated giving way and/or recurrent ankle sprains. Multiple underlying deficits have been proposed, among which ankle muscle strength deficits, proprioception deficits, ( static and dynamic balance disorders, and articular laxity. Unfortunately, no consensus exists on which clinical tests should be realized to determine if one of these underlying deficits is predominant and as a result could guide the rehabilitation process. The study hypothesis is that people with chronic ankle instability might be heterogenous and could be divided in different subgroups as a function of underlying deficits. Therefore, this study aims to evaluate the capacity of different clinical tests to differentiate people with chronic ankle instability from healthy people as well as between each other.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case subjects adult patients with chronic ankle instability | – | –Male or female subjects aged 18-45, presenting : * at least one acute lateral ankle sprain (i.e. initial ankle sprain more than 12 months before inclusion), * at least one residual symptom (giving way OR sensation of instability OR recurrent ankle sprain), confirmed by a score < 24 on the Chronic Ankle Instability Tool (CAIT) * Impact on activities of daily living and sport, score < 90% on Foot and Ankle Ability Measure (FAAM) and < 80% on FAAM-sport Case subjects are free of any other lower extremity pathologies or pain Subjects presenting bilateral chronic ankle instability are excluded |
| Healthy subjects | – | –Male or female subjects aged 18-45 (matched with case Healthy subjects), without any lower extremity pathologies |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults (18-45 yrs) living in the northern part of France close to or in Lille, Saint-Omer and Amiens
Key inclusion criteria (3 listed)
- Case subject : at least one initial lateral ankle sprain more than 12 months before inclusion
- Case subject : at least one residual symptom among (1) giving way, (2) sensation of instability, (3) recurrent ankle sprain. This item is confirmed by a score inferior than 24 on the Chronic Ankle Instability Tool (CAIT)
- Case subject : Impact on activities of daily living and sport, confirmed by a score of less than 90% on the Foot and Ankle Ability Measure (FAAM) and less than 80% on FAAM-- - -- Control subject : matched by age and sex to case subjects
Key exclusion criteria (8 listed)
- Surgery of one of the lower limbs less than 3 years ago
- Presence of heavy pain (EVA > 8) regardless of its origin
- Acute lateral ankle sprain less than 4 months before inclusion
- Neurological disorders of any kind
- Medical treatment (drugs) interfering with muscle tone, balance and proprioception disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Static balance tests
Time frame: Baseline
Static balance tests ( DLS and SLS (both ankles tested) ; Stabilometry) are composite measure * Centre of Pressure (COP) displacement (mm) ; * COP velocity (mm/s) * COP area (mm²) * COP time-to-boundary (TTB) (s) * Number of foot lifts (integer)
the Star Excursion Balance Test (SEBT)
Time frame: Baseline
Dynamic balance test : SEBT (both ankles tested) : are composite measure * Distance reached in anterior direction (% leg length) * Distance reached in posteromedial direction (% leg length) * Distance reached in posterolateral direction (% leg length) * Time used to reach (s) * COP displacement (mm) * COP velocity (s) * COP area (mm²) * COP time-to-boundary (TTB) (s)
Hop tests
Time frame: Baseline
Hop tests (both ankles tested) : SLHD et SH ; are composite measure * Distance reached (m) * Max inversion angle ankle joint (°) * Max internal rotation angle ankle joint (°) * Max vertical Ground Reaction Force (GRF) at landing (N) * Max lateral GRF (N) * Time used to complete 10 hops (s)
Strength tests (both ankles tested)
Time frame: Baseline
Isokinetic strength tests (both ankles tested) : * Plantar flexor peak torque (Nm) * Dorsiflexor peak torque (Nm) * Inversion peak torque (Nm) * Eversion Peak torque (Nm)
1 secondary outcome
Intra-class correlation coefficients (reproducibility test-retest)
Time frame: Baseline and 1-4 weeks after baseline
Results and safety
The study was stopped early (reason given: insufficiency inclusion; covid crisis ; sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Arnould, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Dislocation and Chronic Ankle Instability, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: insufficiency inclusion; covid crisis ; sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance tests (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.