<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/NCT01706757</url>
  </required_header>
  <id_info>
    <org_study_id>11-PP-05</org_study_id>
    <nct_id>NCT01706757</nct_id>
  </id_info>
  <brief_title>Assessment of Motivity in People Aged 65 to 86 Years</brief_title>
  <official_title>Assessment of Motivity in People Aged 65 to 86 Years : Comparison of a Standard Assessment Versus a Technological Solution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Department of Clinical Research and Innovation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ability to walk is one of the fundamental attributes of human beings. However, with&#xD;
      advancing age this ability is modified by a combination of physiological and pathological&#xD;
      aging.These changes mainly involve an irregularity of the pitch, reducing the length of the&#xD;
      stride, instability and a decrease in walking speed (Beauchet et al., 2002). Tinetti,&#xD;
      Speecheley, Ginter (1988, from Ch Wider, F. Vingerhoets, J Bogousslavsky, 2005) show that&#xD;
      20-30% of heathly older fall each year and state that one of these falls, 25% result in&#xD;
      injuries with significant effect and 5% a fracture. In addition to the risk of fracture fear&#xD;
      of falling exists in many older people even before a drop in effective (Recommandation of&#xD;
      HAS, 2005).In France, about 9 000 deaths of people aged over 65 are associated each year with&#xD;
      a fall and this association increases rapidly with advancing age in both sexes. It is&#xD;
      therefore important in terms of public health, learn to recognize the gait disturbance, to&#xD;
      prevent and to make adequate assessments to reduce the risk of falls. Tools exist to assess&#xD;
      the risk of falling. Some are comprehensive but time-consuming and are generally discarded in&#xD;
      favour of other simpler tests (test of Tinetti or get up and go test). However, the listing&#xD;
      of these lacks precision, particularly in terms of duration single timer.To overcome these&#xD;
      biases, innovative technology solutions seem to be a good way. In this study, the&#xD;
      investigators will use the motorized go-cart developed by INRIA, entitled ANG (for Assisted&#xD;
      Navigation Guide), to obtain more reliable and accurate measurements of parameters such as&#xD;
      walking speed and direction. Thus, the investigators set the main objective, to compare a&#xD;
      standard evaluation of the process to a technology assessment, in participants aged 65 to 86&#xD;
      years. And as secondary objectives : evaluate the acceptance of using go-cart ANG in the&#xD;
      elderly, develop an index of walking and test the feasibility of detecting a weakness of the&#xD;
      knee joint by ANG undetected at clinic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2011</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Walking speed.</measure>
    <time_frame>one day</time_frame>
    <description>Walking speed. This will be calculated from an exercise where participants will be asked to walk from one point to another of the room according to the instructions set out below.&#xD;
The average speed of walking in technology assessment, will be directly collected by ANG.&#xD;
A comparison of estimated speeds as standard and technology can then be performed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>acceptance of the go-cart</measure>
    <time_frame>one day</time_frame>
    <description>to assess the acceptance of ANG in the elderly. A questionnaire after the experiment will determine the level of acceptance of the go-cart, and to assess its ease of use.&#xD;
Develop mathematical algorithms to index certain characteristics of the market depending on the linear trajectory, U-turns. c) The detection of a weak joint. d) The index of walking on a path set will be made with and without use of the go-cart. e) Evaluate the ability of subjects to perform complex and precise trajectories</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Assessment of Motivity</condition>
  <arm_group>
    <arm_group_label>with go-cart</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>conducts exercises with the help of a go-cart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without go-cart</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>conduct exercises without go-cart</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>go-cart</intervention_name>
    <description>conducts exercises with the help of a go-cart</description>
    <arm_group_label>with go-cart</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men and women aged between 65 and 86 years&#xD;
&#xD;
          -  participants with no locomotor disability hindering the implementation of the protocol&#xD;
&#xD;
          -  participants with no global cognitive impairment (MMSE score &lt;24) (Folstein et al.&#xD;
             1975), or arguments in favor of the following diagnoses : probable Alzheimer's disease&#xD;
             according to the criteria of the NINCDS-ADRDA, major depressive episode according to&#xD;
             DSM-IV-R&#xD;
&#xD;
          -  participant with no apathy according to diagnostic criteria for apathy (Robert, Onyike&#xD;
             et al. 2009)&#xD;
&#xD;
          -  participants recipients of social security&#xD;
&#xD;
          -  signature of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  impossibility of carrying out the experimental protocol because of a mobility&#xD;
             impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>86 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Robert, Md, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julie Piano, Psychologue</last_name>
    <phone>33 (0)4 92 03 47 75</phone>
    <email>piano.j@chu-nice.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Mémoire de Ressources et de Recherche</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Piano, Psychologue</last_name>
      <phone>33 (0)4 92 03 47 75</phone>
      <email>piano/j@chu-nice.fr</email>
    </contact>
    <contact_backup>
      <last_name>Philippe Robert, MD, PhD</last_name>
      <phone>33 (0)4 92 03 47 70</phone>
      <email>robert.p@chu-nice.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Philippe Robert, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2012</verification_date>
  <study_first_submitted>June 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire de Nice</investigator_affiliation>
    <investigator_full_name>Department of Clinical Research and Innovation</investigator_full_name>
    <investigator_title>Department of Clinical Research and Innovation (drc)</investigator_title>
  </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/NCT01706757
org study id: 11-PP-05
nct id: NCT01706757
lead sponsor: 
has dmc: No
The ability to walk is one of the fundamental attributes of human beings. However, with
      advancing age this ability is modified by a combination of physiological and pathological
      aging.These changes mainly involve an irregularity of the pitch, reducing the length of the
      stride, instability and a decrease in walking speed (Beauchet et al., 2002). Tinetti,
      Speecheley, Ginter (1988, from Ch Wider, F. Vingerhoets, J Bogousslavsky, 2005) show that
      20-30% of heathly older fall each year and state that one of these falls, 25% result in
      injuries with significant effect and 5% a fracture. In addition to the risk of fracture fear
      of falling exists in many older people even before a drop in effective (Recommandation of
      HAS, 2005).In France, about 9 000 deaths of people aged over 65 are associated each year with
      a fall and this association increases rapidly with advancing age in both sexes. It is
      therefore important in terms of public health, learn to recognize the gait disturbance, to
      prevent and to make adequate assessments to reduce the risk of falls. Tools exist to assess
      the risk of falling. Some are comprehensive but time-consuming and are generally discarded in
      favour of other simpler tests (test of Tinetti or get up and go test). However, the listing
      of these lacks precision, particularly in terms of duration single timer.To overcome these
      biases, innovative technology solutions seem to be a good way. In this study, the
      investigators will use the motorized go-cart developed by INRIA, entitled ANG (for Assisted
      Navigation Guide), to obtain more reliable and accurate measurements of parameters such as
      walking speed and direction. Thus, the investigators set the main objective, to compare a
      standard evaluation of the process to a technology assessment, in participants aged 65 to 86
      years. And as secondary objectives : evaluate the acceptance of using go-cart ANG in the
      elderly, develop an index of walking and test the feasibility of detecting a weakness of the
      knee joint by ANG undetected at clinic.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Walking speed.
time frame: one day
description: Walking speed. This will be calculated from an exercise where participants will be asked to walk from one point to another of the room according to the instructions set out below.
The average speed of walking in technology assessment, will be directly collected by ANG.
A comparison of estimated speeds as standard and technology can then be performed.
measure: acceptance of the go-cart
time frame: one day
description: to assess the acceptance of ANG in the elderly. A questionnaire after the experiment will determine the level of acceptance of the go-cart, and to assess its ease of use.
Develop mathematical algorithms to index certain characteristics of the market depending on the linear trajectory, U-turns. c) The detection of a weak joint. d) The index of walking on a path set will be made with and without use of the go-cart. e) Evaluate the ability of subjects to perform complex and precise trajectories
arm group label: with go-cart
arm group type: Experimental
description: conducts exercises with the help of a go-cart
arm group label: without go-cart
arm group type: No Intervention
description: conduct exercises without go-cart
intervention type: Device
intervention name: go-cart
description: conducts exercises with the help of a go-cart
arm group label: with go-cart
criteria: 
gender: All
minimum age: 65 Years
maximum age: 86 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe Robert, Md, PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nice
last name: Julie Piano, Psychologue
phone: 33 (0)4 92 03 47 75
email: piano.j@chu-nice.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Centre Hospitalier Universitaire de Nice
investigator full name: Department of Clinical Research and Innovation
investigator title: Department of Clinical Research and Innovation (drc)