<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/NCT03307265</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB-Weighted jacket</org_study_id>
    <nct_id>NCT03307265</nct_id>
  </id_info>
  <brief_title>Impact of the Use of a Weighted Jacket on the Balance of Patients With a Balance Disorder.</brief_title>
  <official_title>Impact of the Use of a Weighted Jacket on the Balance (While Walking or Standing) of Patients With a Balance Disorder.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bernard Dachy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</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>
      The aim of the study is to test whether wearing a weighted jacket can help improve the&#xD;
      balance distortion of patients with neurologic pathologies.&#xD;
&#xD;
      The center of mass of the patient will be analyzed in order to determine the direction in&#xD;
      which the imbalance is most important. Weights will be placed accordingly in a jacket in&#xD;
      order to correct the imbalance. In the experimental group, weights will represent 1.5 to 2%&#xD;
      of the patient body mass. In the control group, the investigators will use weights of 200&#xD;
      grams maximum, placed evenly on both sides of the jacket. Patients will wear the jacket for 2&#xD;
      consecutive hours.&#xD;
&#xD;
      After wearing the jacket for 2 hours, data similar to those recorded at the beginning of the&#xD;
      experiment will be taken again, namely the determination of the center of mass and of the&#xD;
      deviations caused by the imbalance.&#xD;
&#xD;
      A final series of tests will take place approximately one week after wearing the jacket, to&#xD;
      determine if there are any residual effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">July 27, 2018</completion_date>
  <primary_completion_date type="Actual">July 27, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Imbalance</measure>
    <time_frame>Data measured after 2 hours of jacket utilisation</time_frame>
    <description>The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time Up and Go</measure>
    <time_frame>Data measured after 2 hours of jacket utilisation</time_frame>
    <description>The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tinetti test</measure>
    <time_frame>Data measured after 2 hours of jacket utilisation</time_frame>
    <description>The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berg balance scale</measure>
    <time_frame>Data measured after 2 hours of jacket utilisation</time_frame>
    <description>The Berg balance scale includes 14 tests that assess static balance and dynamic balance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Imbalance</measure>
    <time_frame>1 week after jacket utilisation</time_frame>
    <description>The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Up and Go</measure>
    <time_frame>1 week after jacket utilisation</time_frame>
    <description>The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tinetti test</measure>
    <time_frame>1 week after jacket utilisation</time_frame>
    <description>The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg balance scale</measure>
    <time_frame>1 week after jacket utilisation</time_frame>
    <description>The Berg balance scale includes 14 tests that assess static balance and dynamic balance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Balance; Distorted</condition>
  <arm_group>
    <arm_group_label>Imbalance correction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Personalized weighted jacket</intervention_name>
    <description>Patients in this group will wear a jacket with weights (1,5 to 2% of the total body mass) strategically placed in order to correct their imbalance.</description>
    <arm_group_label>Imbalance correction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control jacket</intervention_name>
    <description>Patients in this group will wear a jacket with weights (200 grams maximum) evenly distributed.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  good level of French understanding&#xD;
&#xD;
          -  be able to walk a minimum distance of 10 meters with or without rod/walker&#xD;
&#xD;
          -  walk 10 meters in more than 12 seconds.&#xD;
&#xD;
          -  have a diagnosis of Multiple Sclerosis, Parkinson's, or any other neurological&#xD;
             pathology that could cause balance disorders&#xD;
&#xD;
          -  be able to endure at least 2 hours of tests, interviews or medical care.&#xD;
&#xD;
          -  score of more than 8 seconds at the time up and go (TUG), less than 24 points out of&#xD;
             28 in the Tinetti test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the patient underwent a period of exacerbation of his pathology in the last two months&#xD;
             (especially for multiple sclerosis patients)&#xD;
&#xD;
          -  chronic back pain&#xD;
&#xD;
          -  poor eyesight (not be able to perform the tests)&#xD;
&#xD;
          -  osteoporosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Brugmann</name>
      <address>
        <city>Brussel</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Bernard Dachy</investigator_full_name>
    <investigator_title>Head of neurology department</investigator_title>
  </responsible_party>
  <keyword>Weighted Jacket</keyword>
  <keyword>Balance disorder</keyword>
  <keyword>Equilibrium disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03307265
org study id: CHUB-Weighted jacket
nct id: NCT03307265
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to test whether wearing a weighted jacket can help improve the
      balance distortion of patients with neurologic pathologies.

      The center of mass of the patient will be analyzed in order to determine the direction in
      which the imbalance is most important. Weights will be placed accordingly in a jacket in
      order to correct the imbalance. In the experimental group, weights will represent 1.5 to 2%
      of the patient body mass. In the control group, the investigators will use weights of 200
      grams maximum, placed evenly on both sides of the jacket. Patients will wear the jacket for 2
      consecutive hours.

      After wearing the jacket for 2 hours, data similar to those recorded at the beginning of the
      experiment will be taken again, namely the determination of the center of mass and of the
      deviations caused by the imbalance.

      A final series of tests will take place approximately one week after wearing the jacket, to
      determine if there are any residual effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Imbalance
time frame: Data measured after 2 hours of jacket utilisation
description: The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.
measure: Time Up and Go
time frame: Data measured after 2 hours of jacket utilisation
description: The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
measure: Tinetti test
time frame: Data measured after 2 hours of jacket utilisation
description: The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.
measure: Berg balance scale
time frame: Data measured after 2 hours of jacket utilisation
description: The Berg balance scale includes 14 tests that assess static balance and dynamic balance.
measure: Imbalance
time frame: 1 week after jacket utilisation
description: The side towards which the patient is more likely to be unbalanced is determined by an interactive balance linked to the Wii-fit.
measure: Time Up and Go
time frame: 1 week after jacket utilisation
description: The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
measure: Tinetti test
time frame: 1 week after jacket utilisation
description: The Tinetti test or score is a simple, reproducible way of assessing the risk of falls.
measure: Berg balance scale
time frame: 1 week after jacket utilisation
description: The Berg balance scale includes 14 tests that assess static balance and dynamic balance.
arm group label: Imbalance correction
arm group type: Experimental
arm group label: Control
arm group type: Active Comparator
intervention type: Device
intervention name: Personalized weighted jacket
description: Patients in this group will wear a jacket with weights (1,5 to 2% of the total body mass) strategically placed in order to correct their imbalance.
arm group label: Imbalance correction
intervention type: Device
intervention name: Control jacket
description: Patients in this group will wear a jacket with weights (200 grams maximum) evenly distributed.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Bernard Dachy
investigator title: Head of neurology department
mesh term: Body Weight
sharing ipd: No