<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/NCT02214329</url>
  </required_header>
  <id_info>
    <org_study_id>1100000467</org_study_id>
    <nct_id>NCT02214329</nct_id>
  </id_info>
  <brief_title>Sensor-based Balance Training in Diabetes: A Virtual Reality Paradigm</brief_title>
  <official_title>Game-Based Virtual Reality Approach for Improving Balance, Reducing Falls, and Preventing Complications In Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Qatar National Research Foundation, Qatar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients,&#xD;
      thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy&#xD;
      of a virtual reality game based exercise training for improving postural body sway and gait&#xD;
      in diabetes patients with peripheral neuropathy. The exercise training has been specifically&#xD;
      designed for DPN patients with lost lower extremity joint perception and uses&#xD;
      state-of-the-art inertial sensors (body-worn) to acquire joint movement and provide real-time&#xD;
      joint feedback through an interactive interface on a LCD monitor. The investigators&#xD;
      hypothesize that tailored exercise with real-time visual joint feedback during exercise will&#xD;
      reduce improve balance and gait.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The game includes a series of ankle reaching tasks and crossing of virtual obstacles on the&#xD;
      monitor screen; these exercises are aimed to improve weight shifting capabilities and&#xD;
      medial-lateral movement of body.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postural Balance</measure>
    <time_frame>6 weeks</time_frame>
    <description>Postural balance is assess at baseline and post-training using body-worn sensors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait</measure>
    <time_frame>6 weeks</time_frame>
    <description>Gait is assessed at baseline and post-training using body-worn sensors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Physical activities of daily living are assessed at baseline and post-training using a T-shirt embedded body-worn sensor (PAMSys)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Performance</measure>
    <time_frame>6 weeks</time_frame>
    <description>Tests, including 3m timed up and go test and alternative step test, are performed. Time is recorded using a stop watch.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Sensor-based exercise training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group receives sensor-based balance training with real-time joint feedback through an interactive interface on LC monitor screen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-home balance training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group performs similar exercise as intervention group at home without use of sensor or any joint feedback from sensor data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sensor-based exercise training</intervention_name>
    <description>Body-worn sensors are mounted on different body segments to acquire joint kinematic data and provide real-time joint feedback during exercise training.</description>
    <arm_group_label>Sensor-based exercise training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>In-home balance training</intervention_name>
    <description>The control group performs similar exercise as intervention without sensors and with no visual feedback from sensors.</description>
    <arm_group_label>In-home balance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetic peripheral neuropathy&#xD;
&#xD;
          -  Age &gt; 50 (Men or Women)&#xD;
&#xD;
          -  Able to walk 60 feet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major lower extremity amputation&#xD;
&#xD;
          -  Cognitive deficits (MMSE 24 or below)&#xD;
&#xD;
          -  Severely impaired vision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David G Armstrong, DPM, MD, PhD</last_name>
      <phone>520-626-1349</phone>
      <email>dga@email.arizona.edu</email>
    </contact>
    <contact_backup>
      <last_name>Bijan Najafi, PhD</last_name>
      <phone>520 626 7097</phone>
      <email>bnajafi@surgery.arizona.edu</email>
    </contact_backup>
    <investigator>
      <last_name>David G Armstrong, DPM, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postural Balance</keyword>
  <keyword>Gait</keyword>
  <keyword>Fall risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT02214329
org study id: 1100000467
nct id: NCT02214329
lead sponsor: 
collaborator: 
has dmc: No
Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients,
      thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy
      of a virtual reality game based exercise training for improving postural body sway and gait
      in diabetes patients with peripheral neuropathy. The exercise training has been specifically
      designed for DPN patients with lost lower extremity joint perception and uses
      state-of-the-art inertial sensors (body-worn) to acquire joint movement and provide real-time
      joint feedback through an interactive interface on a LCD monitor. The investigators
      hypothesize that tailored exercise with real-time visual joint feedback during exercise will
      reduce improve balance and gait.
The game includes a series of ankle reaching tasks and crossing of virtual obstacles on the
      monitor screen; these exercises are aimed to improve weight shifting capabilities and
      medial-lateral movement of body.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Postural Balance
time frame: 6 weeks
description: Postural balance is assess at baseline and post-training using body-worn sensors
measure: Gait
time frame: 6 weeks
description: Gait is assessed at baseline and post-training using body-worn sensors
measure: Physical Activity
time frame: 6 weeks
description: Physical activities of daily living are assessed at baseline and post-training using a T-shirt embedded body-worn sensor (PAMSys)
measure: Functional Performance
time frame: 6 weeks
description: Tests, including 3m timed up and go test and alternative step test, are performed. Time is recorded using a stop watch.
arm group label: Sensor-based exercise training
arm group type: Experimental
description: The intervention group receives sensor-based balance training with real-time joint feedback through an interactive interface on LC monitor screen.
arm group label: In-home balance training
arm group type: Active Comparator
description: The control group performs similar exercise as intervention group at home without use of sensor or any joint feedback from sensor data.
intervention type: Device
intervention name: Sensor-based exercise training
description: Body-worn sensors are mounted on different body segments to acquire joint kinematic data and provide real-time joint feedback during exercise training.
arm group label: Sensor-based exercise training
intervention type: Other
intervention name: In-home balance training
description: The control group performs similar exercise as intervention without sensors and with no visual feedback from sensors.
arm group label: In-home balance training
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus