<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/NCT01732653</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-12-NG-0505-CTIL</org_study_id>
    <secondary_id>VTIME</secondary_id>
    <nct_id>NCT01732653</nct_id>
  </id_info>
  <brief_title>A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults</brief_title>
  <acronym>VTIME</acronym>
  <official_title>V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Medical Center Nijmegen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universita degli Studi di Genova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed randomized controlled trial will evaluate the effects of treadmill training&#xD;
      augmented with virtual reality on fall risk.&#xD;
&#xD;
      300 older adults with a history of falls will be recruited to participate in this study. This&#xD;
      will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and&#xD;
      patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the&#xD;
      intervention group (treadmill training with virtual reality) or to the active-control group&#xD;
      (treadmill training without virtual reality). Each person will participate in a training&#xD;
      program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take&#xD;
      place before, after, and 1 month and 6 months after the completion of the training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, single blinded, parallel group, randomized controlled trial with 6 month&#xD;
      follow-up will be employed to investigate the effects of treadmill training augmented with&#xD;
      virtual reality on fall risk. The study will include 300 older participants who have&#xD;
      experienced two or more falls in the previous 6 months. Participants will be randomized to&#xD;
      either the intervention or control group. The intervention group will receive 18 sessions of&#xD;
      Treadmill Training with Virtual Reality (TT+VR) and the active control comparison will&#xD;
      receive 18 training sessions of treadmill training alone (TT) without the VR simulation All&#xD;
      interventions will be delivered by therapists trained in the standard protocols. All subjects&#xD;
      will be trained 3 times a week for 6 weeks, each session will last approximately 45&#xD;
      minutes.Training progression will be based on increasing both motor and cognitive challenges,&#xD;
      individualized to the participant's level of performance.&#xD;
&#xD;
      Primary outcome measures:&#xD;
&#xD;
      The primary outcome measure of the study is fall rate for 6 months post intervention.&#xD;
      Secondary outcome measures will include gait speed and gait variability under usual and dual&#xD;
      task conditions and while negotiating physical obstacles will be measured. Endurance will be&#xD;
      assessed using the 2 Minute Walk Test and mobility will be assessed using the Four Square&#xD;
      Step Test (FSST), The Short Physical Performance Battery (SPPB) and the mini-Balance&#xD;
      Evaluation Systems Test (mini-BESTest). Community ambulation will be assessed using a&#xD;
      tri-axial accelerometer ('Axivity' Ltd.)which will be worn by the participants for 7 days.&#xD;
      Cognitive function will be assessed using a computerized neuropsychological test battery&#xD;
      (Mindstreams, 'NeuroTrax' Corp., NJ) as well as standardized neuropsychological tests&#xD;
      (Montreal Cognitive Assessment,The Trail Making Test; Verbal Fluency). Quality of life will&#xD;
      be evaluated using the SF-36 Health Survey&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">April 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Falls rate</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>The primary outcome measure of the study is fall rate. Participants will keep a falls calendar for 6 months post intervention. Each time the participant falls he/she will tick the date on the calendar. These calendars will be returned to the researchers once a month in a pre-addressed envelope.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gait</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>Gait speed and gait variability under usual and dual task conditions and while negotiating physical obstacles will be measured. Participants will be asked to walk in a well-lit corridor under 3 conditions each of 1 minute: i) walking in a comfortable speed, ii) walking while subtracting 3s from a predefined number (dual task), iii) walking while negotiating two obstacles placed on the floor at specific locations. Spatial-temporal gait characteristics (e.g., gait speed (m/s), stride length (m), stride time (s), swing time (%), asymmetry, and step width (cm)) will be determined. Endurance will be assessed using the 2 Minute Walk Test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>Cognitive function will be assessed using a computerized neuropsychological test battery (Mindstreams, NeuroTrax Corp., NJ). In addition, we will also include standardized neuropsychological tests such as the Montreal Cognitive Assessment (MoCA); The Trail Making Test (TMT) and the Verbal Fluency test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance and mobility</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>The Four Square Step Test (FSST), The Short Physical Performance Battery (SPPB) and the mini-Balance Evaluation Systems Test (mini-BESTest) will be used to assess mobility. Community ambulation will be assessed using The Physical Activity Scale for the Elderly (PASE) and a tri-axial accelerometer (Axivity Ltd.) which will be worn by the participants for 7 days to quantify and monitor stepping and physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>The SF-36 Health Survey, a generic self-report questionnaire designed to address health related quality of life will be used. Fear of Falling will be evaluated using the Falls Efficacy Scale-International.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">302</enrollment>
  <condition>Elderly Adults</condition>
  <condition>Parkinson</condition>
  <condition>Mild Cognitive Disorder</condition>
  <arm_group>
    <arm_group_label>TT+VR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The training will consist of walking on the treadmill while negotiating obstacles in a virtual reality simulation.Training will be provided3 times a week for a duration of 6 weeks (total of 18 sessions).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TT alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The training will consist of walking on the treadmill 3 times a week for a duration of 6 weeks (total of 18 sessions).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TT+VR</intervention_name>
    <description>subjects will be walking on a treadmill while negotiating virtual obstacles provided by a computer simulation. The virtual environment will consist of obstacles, different pathways, narrow corridors and distracters, requiring modulations of step amplitude in two planes (i.e., height and width) coordinated with walking behaviour. The speed, orientation, size, frequency of appearance and shape of the targets will be manipulated according to individual needs following a standardized protocol.</description>
    <arm_group_label>TT+VR</arm_group_label>
    <other_name>training on a treadmill with virtual reality</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TT alone</intervention_name>
    <description>The participants will walk on the treadmill, their gait speed over-ground will be measured at the beginning of each week of training. Progression will include increasing the duration of each of the walking bouts and increasing walking speed.</description>
    <arm_group_label>TT alone</arm_group_label>
    <other_name>treadmill training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2 or more falls within 6 months prior to the beginning of the study&#xD;
&#xD;
          -  Aged 60-85 years&#xD;
&#xD;
          -  Able to walk for 5 minutes unassisted&#xD;
&#xD;
          -  Adequate hearing and vision capabilities.&#xD;
&#xD;
          -  Stable medication for the past 1 month and anticipated over a period of 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric co-morbidity&#xD;
&#xD;
          -  Clinical diagnosis of dementia or other severe cognitive impairment (MMSE&lt;24)&#xD;
&#xD;
          -  History of stroke, traumatic brain injury or other neurological disorders (other than&#xD;
             PD and MCI, for those groups)&#xD;
&#xD;
          -  Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and&#xD;
             orthopaedic diseases&#xD;
&#xD;
          -  Unstable medical condition in the past 6 months&#xD;
&#xD;
          -  Unable to comply with the training&#xD;
&#xD;
          -  Interfering therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey M Hausdorff, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel-Aviv Sourasky Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Rehabilitation Sciences, Katholieke Universiteit Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Neurosciences Universita Degli Studi Di Genova, Italy</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Geriatric Medicine and Neurology, Radboud University Nijmegen Medical Center The Netherlands</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Aging and Health, University of Newcastle, UK</name>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>April 17, 2016</last_update_submitted>
  <last_update_submitted_qc>April 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>virtual reality,</keyword>
  <keyword>falls,</keyword>
  <keyword>elderly,</keyword>
  <keyword>Parkinson's disease,</keyword>
  <keyword>MCI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Cognition Disorders</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/NCT01732653
org study id: TASMC-12-NG-0505-CTIL
secondary id: VTIME
nct id: NCT01732653
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The proposed randomized controlled trial will evaluate the effects of treadmill training
      augmented with virtual reality on fall risk.

      300 older adults with a history of falls will be recruited to participate in this study. This
      will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and
      patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the
      intervention group (treadmill training with virtual reality) or to the active-control group
      (treadmill training without virtual reality). Each person will participate in a training
      program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take
      place before, after, and 1 month and 6 months after the completion of the training.
A prospective, single blinded, parallel group, randomized controlled trial with 6 month
      follow-up will be employed to investigate the effects of treadmill training augmented with
      virtual reality on fall risk. The study will include 300 older participants who have
      experienced two or more falls in the previous 6 months. Participants will be randomized to
      either the intervention or control group. The intervention group will receive 18 sessions of
      Treadmill Training with Virtual Reality (TT+VR) and the active control comparison will
      receive 18 training sessions of treadmill training alone (TT) without the VR simulation All
      interventions will be delivered by therapists trained in the standard protocols. All subjects
      will be trained 3 times a week for 6 weeks, each session will last approximately 45
      minutes.Training progression will be based on increasing both motor and cognitive challenges,
      individualized to the participant's level of performance.

      Primary outcome measures:

      The primary outcome measure of the study is fall rate for 6 months post intervention.
      Secondary outcome measures will include gait speed and gait variability under usual and dual
      task conditions and while negotiating physical obstacles will be measured. Endurance will be
      assessed using the 2 Minute Walk Test and mobility will be assessed using the Four Square
      Step Test (FSST), The Short Physical Performance Battery (SPPB) and the mini-Balance
      Evaluation Systems Test (mini-BESTest). Community ambulation will be assessed using a
      tri-axial accelerometer ('Axivity' Ltd.)which will be worn by the participants for 7 days.
      Cognitive function will be assessed using a computerized neuropsychological test battery
      (Mindstreams, 'NeuroTrax' Corp., NJ) as well as standardized neuropsychological tests
      (Montreal Cognitive Assessment,The Trail Making Test; Verbal Fluency). Quality of life will
      be evaluated using the SF-36 Health Survey
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Falls rate
time frame: 6 months post intervention
description: The primary outcome measure of the study is fall rate. Participants will keep a falls calendar for 6 months post intervention. Each time the participant falls he/she will tick the date on the calendar. These calendars will be returned to the researchers once a month in a pre-addressed envelope.
measure: Gait
time frame: 6 months post intervention
description: Gait speed and gait variability under usual and dual task conditions and while negotiating physical obstacles will be measured. Participants will be asked to walk in a well-lit corridor under 3 conditions each of 1 minute: i) walking in a comfortable speed, ii) walking while subtracting 3s from a predefined number (dual task), iii) walking while negotiating two obstacles placed on the floor at specific locations. Spatial-temporal gait characteristics (e.g., gait speed (m/s), stride length (m), stride time (s), swing time (%), asymmetry, and step width (cm)) will be determined. Endurance will be assessed using the 2 Minute Walk Test.
measure: Cognitive function
time frame: 6 months post intervention
description: Cognitive function will be assessed using a computerized neuropsychological test battery (Mindstreams, NeuroTrax Corp., NJ). In addition, we will also include standardized neuropsychological tests such as the Montreal Cognitive Assessment (MoCA); The Trail Making Test (TMT) and the Verbal Fluency test.
measure: Balance and mobility
time frame: 6 months post intervention
description: The Four Square Step Test (FSST), The Short Physical Performance Battery (SPPB) and the mini-Balance Evaluation Systems Test (mini-BESTest) will be used to assess mobility. Community ambulation will be assessed using The Physical Activity Scale for the Elderly (PASE) and a tri-axial accelerometer (Axivity Ltd.) which will be worn by the participants for 7 days to quantify and monitor stepping and physical activity.
measure: Quality of life
time frame: 6 months post intervention
description: The SF-36 Health Survey, a generic self-report questionnaire designed to address health related quality of life will be used. Fear of Falling will be evaluated using the Falls Efficacy Scale-International.
arm group label: TT+VR
arm group type: Experimental
description: The training will consist of walking on the treadmill while negotiating obstacles in a virtual reality simulation.Training will be provided3 times a week for a duration of 6 weeks (total of 18 sessions).
arm group label: TT alone
arm group type: Active Comparator
description: The training will consist of walking on the treadmill 3 times a week for a duration of 6 weeks (total of 18 sessions).
intervention type: Other
intervention name: TT+VR
description: subjects will be walking on a treadmill while negotiating virtual obstacles provided by a computer simulation. The virtual environment will consist of obstacles, different pathways, narrow corridors and distracters, requiring modulations of step amplitude in two planes (i.e., height and width) coordinated with walking behaviour. The speed, orientation, size, frequency of appearance and shape of the targets will be manipulated according to individual needs following a standardized protocol.
arm group label: TT+VR
other name: training on a treadmill with virtual reality
intervention type: Other
intervention name: TT alone
description: The participants will walk on the treadmill, their gait speed over-ground will be measured at the beginning of each week of training. Progression will include increasing the duration of each of the walking bouts and increasing walking speed.
arm group label: TT alone
other name: treadmill training
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jeffrey M Hausdorff, PhD
role: Principal Investigator
affiliation: Tel-Aviv Sourasky Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Israel
country: Italy
country: Netherlands
country: United Kingdom
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Cognitive Dysfunction
mesh term: Cognition Disorders