<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/NCT03286322</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A00521-50</org_study_id>
    <nct_id>NCT03286322</nct_id>
  </id_info>
  <brief_title>Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine</brief_title>
  <acronym>SATRACE</acronym>
  <official_title>Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine to Improve Balance in Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      In more than 90% of cases, victims of fall are elderly people over 65. Nearly the third of&#xD;
      those people fall at least 1 time by year. The incidence substantially increases for people&#xD;
      over 80 and women are at higher risk than men.&#xD;
&#xD;
      The value of balance rehabilitation no longer needs to be demonstrated in Gerontology.&#xD;
      Nevertheless, a more specific therapy based on the aged-related cervical problems seems to be&#xD;
      essential. Indeed, those problems are numerous (arthrosis-like pains, joint stiffness,&#xD;
      muscular contractures…) and often lessen vestibular and/or proprioceptive afferents. The&#xD;
      cervical spine is a link between different systems which regulate balance, as the visual,&#xD;
      vestibular and cervical systems (muscular, articular afferents…), and this role is key to&#xD;
      balance control. Indeed, the cervical spine owns an exceptional function thanks to Ruffinian&#xD;
      corpuscles, muscle and neurotendinal spindles.&#xD;
&#xD;
      Many studies point up the importance of the relation between balance, cervical spine and&#xD;
      vestibular system, and others between tissue changes and postural adaptations in elderly&#xD;
      people. Nevertheless, the take into consideration of all these data and their impacts in&#xD;
      rehabilitation has not been reported yet.&#xD;
&#xD;
      This brings us to question the added-value of a cervical mobility management in balance&#xD;
      rehabilitation in Gerontology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 16, 2016</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage decrease of the wobbling surface eyes open on steady ground, on a posturology platform</measure>
    <time_frame>at 3 weeks</time_frame>
    <description>To compare the balance improvement, thanks to a posturology platform, between 2 groups of elderly patients hospitalized for balance disorders, in order to highlight the way of manual therapy in physiotherapy, focused on the cervical spine, can increase these parameters and contribute to lessen the risk of falls in elderly people.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Loss of Balance</condition>
  <arm_group>
    <arm_group_label>manual therapy cervical spine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>manuel therapy cervical spine</intervention_name>
    <description>the manuel therapy in physiotherapy is focused on the cervival spine</description>
    <arm_group_label>manual therapy cervical spine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control group</intervention_name>
    <description>the manuel therapy in physiotherapy is classic and not focused on the cervival spine</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 75 hospitalized in rehabilitation department and long-term unit of&#xD;
             Cimiez Hospital&#xD;
&#xD;
          -  With MMSE &gt; 20&#xD;
&#xD;
          -  In need of balance rehabilitation&#xD;
&#xD;
          -  Who can stand Bipodal position for &gt;1 minute&#xD;
&#xD;
          -  Who can walk for more than 10 meters without walking aid&#xD;
&#xD;
          -  Having signed an informed consent&#xD;
&#xD;
          -  Affiliated to a health insurance plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Motor neurological deficit, specific vestibular pathologies&#xD;
&#xD;
          -  Patient hospitalized for traumatological pathology or who has been hospitalized for&#xD;
             traumatological pathology within 3 months&#xD;
&#xD;
          -  Vulnerable people: adults under guardianship, deprived of freedom&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sébastien GONFRIER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sylvie MALERBA</last_name>
    <phone>+33492034011</phone>
    <email>drc@chu-nice.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Audrey MARTEU</last_name>
      <phone>+ 33 4 92 03 40 59</phone>
      <email>marteu.a@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>Stéphane GONFRIER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03286322
org study id: 2016-A00521-50
nct id: NCT03286322
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In more than 90% of cases, victims of fall are elderly people over 65. Nearly the third of
      those people fall at least 1 time by year. The incidence substantially increases for people
      over 80 and women are at higher risk than men.

      The value of balance rehabilitation no longer needs to be demonstrated in Gerontology.
      Nevertheless, a more specific therapy based on the aged-related cervical problems seems to be
      essential. Indeed, those problems are numerous (arthrosis-like pains, joint stiffness,
      muscular contractures…) and often lessen vestibular and/or proprioceptive afferents. The
      cervical spine is a link between different systems which regulate balance, as the visual,
      vestibular and cervical systems (muscular, articular afferents…), and this role is key to
      balance control. Indeed, the cervical spine owns an exceptional function thanks to Ruffinian
      corpuscles, muscle and neurotendinal spindles.

      Many studies point up the importance of the relation between balance, cervical spine and
      vestibular system, and others between tissue changes and postural adaptations in elderly
      people. Nevertheless, the take into consideration of all these data and their impacts in
      rehabilitation has not been reported yet.

      This brings us to question the added-value of a cervical mobility management in balance
      rehabilitation in Gerontology.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage decrease of the wobbling surface eyes open on steady ground, on a posturology platform
time frame: at 3 weeks
description: To compare the balance improvement, thanks to a posturology platform, between 2 groups of elderly patients hospitalized for balance disorders, in order to highlight the way of manual therapy in physiotherapy, focused on the cervical spine, can increase these parameters and contribute to lessen the risk of falls in elderly people.
arm group label: manual therapy cervical spine
arm group type: Experimental
arm group label: control group
arm group type: Sham Comparator
intervention type: Other
intervention name: manuel therapy cervical spine
description: the manuel therapy in physiotherapy is focused on the cervival spine
arm group label: manual therapy cervical spine
intervention type: Other
intervention name: control group
description: the manuel therapy in physiotherapy is classic and not focused on the cervival spine
arm group label: control group
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Sébastien GONFRIER, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nice
last name: Sylvie MALERBA
phone: +33492034011
email: drc@chu-nice.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor