<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/NCT02225613</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00390-47</org_study_id>
    <nct_id>NCT02225613</nct_id>
  </id_info>
  <brief_title>Spa Rehabilitation After Cruciate Ligament Injury in Sportsmen</brief_title>
  <acronym>Thermasport</acronym>
  <official_title>Comparison Between Two Rehabilitation Programs (Conventional and Aquatic) After Cruciate Ligament Injury in Sportsmen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Knee cruciate ligament injury is a common injury (15 000 per year in France) which concerns&#xD;
      young sportsmen. Consequences are limitation in physical and sporting activities and at work.&#xD;
&#xD;
      Main objective: to compare water and traditional rehabilitation after cruciate ligament&#xD;
      injury reconstruction in terms of kinematics of recovery and of proprioceptive abilities&#xD;
      development.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Secondary objectives: to compare algo-functional and sport, social and job come back date&#xD;
      between both groups.&#xD;
&#xD;
      Multicentric randomised trial comparing two therapy protocols in knee cruciate ligament&#xD;
      injury.&#xD;
&#xD;
      After surgery, 2 weeks rehabilitation; 3 weeks conventional rehabilitation (group 1) or&#xD;
      rehabilitation in water (group 2).&#xD;
&#xD;
      Data will be collected at inclusion (before surgery), 2 weeks, 1 month, 2 months and 6 months&#xD;
      after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Posturography composite score</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Postural control during quiet stance will be evaluated without and with sensory conflict by a sensory organization test</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Cruciate Ligament Injury</condition>
  <condition>Balance Control</condition>
  <arm_group>
    <arm_group_label>Usual protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 weeks conventional rehabilitation 3 weeks conventional rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spa protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 weeks conventional rehabilitation 3 weeks aquatic rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual protocol</intervention_name>
    <arm_group_label>Usual protocol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spa protocol</intervention_name>
    <arm_group_label>Spa protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults,&#xD;
&#xD;
          -  18-49 years,&#xD;
&#xD;
          -  indication of knee anterior cruciate ligament reconstruction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other recent lower limb sprain,&#xD;
&#xD;
          -  history of neurological disease (stroke, central or peripheral degenerative disease),&#xD;
&#xD;
          -  psychtrope or antihypertensive drugs,&#xD;
&#xD;
          -  aquatic activities contra-indication (cutaneous).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Philippe Perrin, MD, PhD</last_name>
    <phone>+333 83 15 49 68</phone>
    <email>philippe.perrin@univ-lorraine.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nancy University Hospital</name>
      <address>
        <city>Nancy</city>
        <state>Lorraine</state>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe Perrin, MD, PhD, Prof.</last_name>
      <phone>+333 83 15 49 68</phone>
      <email>philippe.perrin@univ-lorraine.fr</email>
    </contact>
    <investigator>
      <last_name>Philippe Perrin, MD, PhD, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michel Boulangé, MD, PhD, Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Didier Mainard, MD, PhD, Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicolas Hummer, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicolas Paris, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Frank Wein, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean Paysant, MD, PhD, Prof.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>August 5, 2016</last_update_submitted>
  <last_update_submitted_qc>August 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cruciate ligament injury</keyword>
  <keyword>Balance control</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Spa therapy</keyword>
  <keyword>Sport</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02225613
org study id: 2014-A00390-47
nct id: NCT02225613
lead sponsor: 
has dmc: Yes
Knee cruciate ligament injury is a common injury (15 000 per year in France) which concerns
      young sportsmen. Consequences are limitation in physical and sporting activities and at work.

      Main objective: to compare water and traditional rehabilitation after cruciate ligament
      injury reconstruction in terms of kinematics of recovery and of proprioceptive abilities
      development.
Secondary objectives: to compare algo-functional and sport, social and job come back date
      between both groups.

      Multicentric randomised trial comparing two therapy protocols in knee cruciate ligament
      injury.

      After surgery, 2 weeks rehabilitation; 3 weeks conventional rehabilitation (group 1) or
      rehabilitation in water (group 2).

      Data will be collected at inclusion (before surgery), 2 weeks, 1 month, 2 months and 6 months
      after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Posturography composite score
time frame: up to 6 months
description: Postural control during quiet stance will be evaluated without and with sensory conflict by a sensory organization test
arm group label: Usual protocol
arm group type: Active Comparator
description: 2 weeks conventional rehabilitation 3 weeks conventional rehabilitation
arm group label: Spa protocol
arm group type: Active Comparator
description: 2 weeks conventional rehabilitation 3 weeks aquatic rehabilitation
intervention type: Other
intervention name: Usual protocol
arm group label: Usual protocol
intervention type: Other
intervention name: Spa protocol
arm group label: Spa protocol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
last name: Philippe Perrin, MD, PhD
phone: +333 83 15 49 68
email: philippe.perrin@univ-lorraine.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Wounds and Injuries