<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03818438</url>
  </required_header>
  <id_info>
    <org_study_id>2017_09</org_study_id>
    <secondary_id>2018-A00102-53</secondary_id>
    <nct_id>NCT03818438</nct_id>
  </id_info>
  <brief_title>Chronic Ankle Instability Diagnostic Tests Determining Underlying Deficits</brief_title>
  <acronym>CAIDiag</acronym>
  <official_title>Biomechanical Analysis, Complementary Examinations and Rehabilitative Management of Chronic Ankle Instability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic ankle instability is a common condition in the active adult population and&#xD;
      characterized by the occurrence of repeated giving way and/or recurrent ankle sprains.&#xD;
      Multiple underlying deficits have been proposed, among which ankle muscle strength deficits,&#xD;
      proprioception deficits, ( static and dynamic balance disorders, and articular laxity.&#xD;
      Unfortunately, no consensus exists on which clinical tests should be realized to determine if&#xD;
      one of these underlying deficits is predominant and as a result could guide the&#xD;
      rehabilitation process. The study hypothesis is that people with chronic ankle instability&#xD;
      might be heterogenous and could be divided in different subgroups as a function of underlying&#xD;
      deficits. Therefore, this study aims to evaluate the capacity of different clinical tests to&#xD;
      differentiate people with chronic ankle instability from healthy people as well as between&#xD;
      each other.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    insufficiency inclusion; covid crisis ; sponsor decision&#xD;
  </why_stopped>
  <start_date type="Actual">October 24, 2019</start_date>
  <completion_date type="Actual">October 25, 2021</completion_date>
  <primary_completion_date type="Actual">October 25, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Static balance tests</measure>
    <time_frame>Baseline</time_frame>
    <description>Static balance tests ( DLS and SLS (both ankles tested) ; Stabilometry) are composite measure&#xD;
Centre of Pressure (COP) displacement (mm) ;&#xD;
COP velocity (mm/s)&#xD;
COP area (mm²)&#xD;
COP time-to-boundary (TTB) (s)&#xD;
Number of foot lifts (integer)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the Star Excursion Balance Test (SEBT)</measure>
    <time_frame>Baseline</time_frame>
    <description>Dynamic balance test : SEBT (both ankles tested) : are composite measure&#xD;
Distance reached in anterior direction (% leg length)&#xD;
Distance reached in posteromedial direction (% leg length)&#xD;
Distance reached in posterolateral direction (% leg length)&#xD;
Time used to reach (s)&#xD;
COP displacement (mm)&#xD;
COP velocity (s)&#xD;
COP area (mm²)&#xD;
COP time-to-boundary (TTB) (s)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hop tests</measure>
    <time_frame>Baseline</time_frame>
    <description>Hop tests (both ankles tested) : SLHD et SH ; are composite measure&#xD;
Distance reached (m)&#xD;
Max inversion angle ankle joint (°)&#xD;
Max internal rotation angle ankle joint (°)&#xD;
Max vertical Ground Reaction Force (GRF) at landing (N)&#xD;
Max lateral GRF (N)&#xD;
Time used to complete 10 hops (s)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength tests (both ankles tested)</measure>
    <time_frame>Baseline</time_frame>
    <description>Isokinetic strength tests (both ankles tested) :&#xD;
Plantar flexor peak torque (Nm)&#xD;
Dorsiflexor peak torque (Nm)&#xD;
Inversion peak torque (Nm)&#xD;
Eversion Peak torque (Nm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra-class correlation coefficients (reproducibility test-retest)</measure>
    <time_frame>Baseline and 1-4 weeks after baseline</time_frame>
    <description>Intra-class correlation coefficients (reproducibility test-retest) calculated on the subset of the parameters identified by the main analysis.&#xD;
Recyclability of the functional clinical tests : Normality testing /Sample comparison</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Ankle Dislocation</condition>
  <condition>Chronic Ankle Instability</condition>
  <arm_group>
    <arm_group_label>Case subjects adult patients with chronic ankle instability</arm_group_label>
    <description>Male or female subjects aged 18-45, presenting :&#xD;
at least one acute lateral ankle sprain (i.e. initial ankle sprain more than 12 months before inclusion),&#xD;
at least one residual symptom (giving way OR sensation of instability OR recurrent ankle sprain), confirmed by a score &lt; 24 on the Chronic Ankle Instability Tool (CAIT)&#xD;
Impact on activities of daily living and sport, score &lt; 90% on Foot and Ankle Ability Measure (FAAM) and &lt; 80% on FAAM-sport Case subjects are free of any other lower extremity pathologies or pain Subjects presenting bilateral chronic ankle instability are excluded</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <description>Male or female subjects aged 18-45 (matched with case Healthy subjects), without any lower extremity pathologies</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults (18-45 yrs) living in the northern part of France close to or in Lille, Saint-Omer&#xD;
        and Amiens&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Case subject : at least one initial lateral ankle sprain more than 12 months before&#xD;
             inclusion&#xD;
&#xD;
          -  Case subject : at least one residual symptom among (1) giving way, (2) sensation of&#xD;
             instability, (3) recurrent ankle sprain. This item is confirmed by a score inferior&#xD;
             than 24 on the Chronic Ankle Instability Tool (CAIT)&#xD;
&#xD;
          -  Case subject : Impact on activities of daily living and sport, confirmed by a score of&#xD;
             less than 90% on the Foot and Ankle Ability Measure (FAAM) and less than 80% on FAAM--&#xD;
             - -- Control subject : matched by age and sex to case subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgery of one of the lower limbs less than 3 years ago&#xD;
&#xD;
          -  Presence of heavy pain (EVA &gt; 8) regardless of its origin&#xD;
&#xD;
          -  Acute lateral ankle sprain less than 4 months before inclusion&#xD;
&#xD;
          -  Neurological disorders of any kind&#xD;
&#xD;
          -  Medical treatment (drugs) interfering with muscle tone, balance and proprioception&#xD;
             disorders&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Body mass index &gt; 30&#xD;
&#xD;
          -  Bilateral chronic ankle instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre Arnould, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH Saint-Omer, institut audomarois de la chirurgie orthopédique et du sport</name>
      <address>
        <city>Saint-Omer</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic instability</keyword>
  <keyword>Strength</keyword>
  <keyword>Proprioception</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Ankle</keyword>
  <keyword>Balance</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03818438
org study id: 2017_09
secondary id: 2018-A00102-53
nct id: NCT03818438
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Control
time perspective: Prospective
measure: Static balance tests
time frame: Baseline
description: 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)
measure: the Star Excursion Balance Test (SEBT)
time frame: Baseline
description: 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)
measure: Hop tests
time frame: Baseline
description: 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)
measure: Strength tests (both ankles tested)
time frame: Baseline
description: Isokinetic strength tests (both ankles tested) :
Plantar flexor peak torque (Nm)
Dorsiflexor peak torque (Nm)
Inversion peak torque (Nm)
Eversion Peak torque (Nm)
measure: Intra-class correlation coefficients (reproducibility test-retest)
time frame: Baseline and 1-4 weeks after baseline
description: 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
arm group label: Case subjects adult patients with chronic ankle instability
description: 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
arm group label: Healthy subjects
description: Male or female subjects aged 18-45 (matched with case Healthy subjects), without any lower extremity pathologies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexandre Arnould, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor