<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/NCT03759106</url>
  </required_header>
  <id_info>
    <org_study_id>CRIR-1319-0218</org_study_id>
    <nct_id>NCT03759106</nct_id>
  </id_info>
  <brief_title>Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach</brief_title>
  <official_title>Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université de Montréal</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>
      Stroke is a leading cause of death and long-term disability worldwide and its incidence is on&#xD;
      the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a&#xD;
      significant long-term impact on activities of daily living, leisure activities and work. The&#xD;
      capacity for recovery following a stroke depends on several factors, including the extent of&#xD;
      the initial neurological damage, spontaneous recovery and rehabilitation, with possible&#xD;
      recovery even years after the stroke. Unfortunately, accessibility of much needed&#xD;
      rehabilitation services poststroke often remains limited, both in terms of intensity and&#xD;
      duration, as reported in a recent report on post-stroke rehabilitation services in Quebec.&#xD;
      Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for&#xD;
      upper limb training post-stroke when rehabilitation services are not available. Similarly,&#xD;
      the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends&#xD;
      home-based patient monitoring be used when frequent monitoring is needed and face-to-face&#xD;
      visits are not available. Hence, the investigators have developed and propose to examine the&#xD;
      use of the VirTele system for people who have suffered a stroke who are no longer receiving&#xD;
      rehabilitation services The VirTele system allows upper limb rehabilitation using exergames&#xD;
      with ongoing off-line monitoring combined with online monitoring and coaching based on the&#xD;
      self-determination theory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More specifically, the primary objective of the RCT is to provide preliminary evidence&#xD;
      regarding efficacy of the VirTele program for upper limb motor control recovery in chronic&#xD;
      stroke. Secondary objectives are to: i. Determine the effect of the VirTele program on upper&#xD;
      limb function, quality of life and motivation; ii. Determine the feasibility of using the&#xD;
      VirTele program with users at home (e.g. adherence, safety, technical difficulties,&#xD;
      facilitators and barriers); iii. Explore the role that shared decision-making and empowerment&#xD;
      play in exercise program adherence and progression, and in behavior modification for&#xD;
      upper-limb use.&#xD;
&#xD;
      This study will also provide evidence of feasibility for conducting a larger-scale RCT&#xD;
      comparing different technologies and interventions for chronic stroke rehabilitation.&#xD;
&#xD;
      A single-blind (evaluator) two-arm randomized clinical trial (RCT) is proposed for this study&#xD;
      with participants who have had a stroke randomly allocated to: (1) 8-week training with the&#xD;
      VirTele system.i.e. treatment group or (2) 8-week written home exercise program provided by a&#xD;
      clinician (GRASP), i.e. exercise control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 27, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</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>Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE)</measure>
    <time_frame>baseline and eight weeks after intervention, as well as 1 and 2 month follow up</time_frame>
    <description>Upper limb motor control is assessed using a valid and reliable outcome, scores between 0-66, higher scores indicating better motor control. measure consisting of tasks to be performed by the participant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Upper limb function at 8 weeks Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use</measure>
    <time_frame>baseline and eight weeks after intervention, as well as 1 and 2 month follow up</time_frame>
    <description>The Motor Activity Log is a questionnaire that the participant completes reporting how much the impaired upper limb is used for various daily tasks, each task is scored from 0-5 (ordinal scale, 0=do not use arm - 6=use as much as before), total score is mean of the scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test</measure>
    <time_frame>baseline and eight weeks after intervention, as well as 1 and 2 month follow up</time_frame>
    <description>The Wolf Motor Function test consists of tasks that are performed by the participant with the impaired upper extremity, the tasks are rated for the quality of movement and the time taken. Items are scored on a 6 point scale, from does not attempt to movement is normal. Times tests are truncated at 120 seconds. A mean score out of a maximum of 5 is calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of sessions (feasibility)</measure>
    <time_frame>8 weeks (ongoing)</time_frame>
    <description>number of sessions played (count)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of sessions (Feasibility)</measure>
    <time_frame>8 weeks (ongoing)</time_frame>
    <description>average duration of sessions played (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of time spent on the actual exe games (moving the arm)</measure>
    <time_frame>8 weeks (ongoing)</time_frame>
    <description>amount of actual time spent using the impaired arm during the sessions (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of on-line consultations with therapist</measure>
    <time_frame>8 weeks (ongoing)</time_frame>
    <description>Number of times real-time sessions are held between the therapist and the participant (online)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration (minutes) of on-line consultations with therapist</measure>
    <time_frame>8 weeks (ongoing)</time_frame>
    <description>average time spent by the therapist assisting for real-time sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse event (counts)</measure>
    <time_frame>8 weeks (ongoing)</time_frame>
    <description>occurrence of adverse events (falls, motion sickness, dizziness, headaches) will be documented using a computerized patient log after each session.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>falls (count)</measure>
    <time_frame>8 weeks (ongoing)</time_frame>
    <description>occurrence of falls documented by the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)</measure>
    <time_frame>8 weeks (ongoing)</time_frame>
    <description>self perceived exertion rated by the participant after the session (i.e. playing the exergame) on a scale 6-20, (no exertion to maximal exertion)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>No Intervention: Usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All study participants in the control group will receive an 8-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Telerehabilitation system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental group will receive 8 weeks home exercise program using a virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and synchronously and the program adapted to ensure it remains at an appropriate level for the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>home written exercise program</intervention_name>
    <description>exercises such as picking up objects, placing objects, frequently prescribed at discharge</description>
    <arm_group_label>No Intervention: Usual care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>telerehabilitation/exergame system</intervention_name>
    <description>Video games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing</description>
    <arm_group_label>Experimental: Telerehabilitation system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ischemic or hemorrhagic stroke (does not have to be a first time stroke);&#xD;
&#xD;
          -  Mild to moderate upper limb impairment (score 2-6 Chedoke-McMaster arm component or&#xD;
             ability to perform VR tasks at least at the lowest setting according to clinician);&#xD;
&#xD;
          -  No longer receiving rehabilitation services;&#xD;
&#xD;
          -  living in an area where high speed Internet access is available.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being medically unstable;&#xD;
&#xD;
          -  Severe cognitive or communication deficits;&#xD;
&#xD;
          -  Visual impairments;&#xD;
&#xD;
          -  Severe balance deficits limiting sitting safely independently;&#xD;
&#xD;
          -  Shoulder pain limiting movements for the game;&#xD;
&#xD;
          -  Previous upper limb impairment limiting potential recovery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dahlia Kairy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Montréal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alejandro Hernandez, MSc</last_name>
    <phone>514-340-2085</phone>
    <email>alejandro.hernandez@mail.mcgill.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dahlia Kairy, phd</last_name>
    <phone>514-343-6301</phone>
    <email>dahlia.kairy@umontreal.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3N 1X7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dorra Allegue, MSc</last_name>
      <email>dorra.allegue@umontreal.ca</email>
    </contact>
    <contact_backup>
      <last_name>Alejandro Hernandez, MSc</last_name>
      <email>alejandro.hernandez@mail.mcgill.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Montréal</investigator_affiliation>
    <investigator_full_name>Dahlia Kairy</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Virtual reality</keyword>
  <keyword>telerehabilitation</keyword>
  <keyword>Stroke rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03759106
org study id: CRIR-1319-0218
nct id: NCT03759106
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke is a leading cause of death and long-term disability worldwide and its incidence is on
      the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a
      significant long-term impact on activities of daily living, leisure activities and work. The
      capacity for recovery following a stroke depends on several factors, including the extent of
      the initial neurological damage, spontaneous recovery and rehabilitation, with possible
      recovery even years after the stroke. Unfortunately, accessibility of much needed
      rehabilitation services poststroke often remains limited, both in terms of intensity and
      duration, as reported in a recent report on post-stroke rehabilitation services in Quebec.
      Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for
      upper limb training post-stroke when rehabilitation services are not available. Similarly,
      the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends
      home-based patient monitoring be used when frequent monitoring is needed and face-to-face
      visits are not available. Hence, the investigators have developed and propose to examine the
      use of the VirTele system for people who have suffered a stroke who are no longer receiving
      rehabilitation services The VirTele system allows upper limb rehabilitation using exergames
      with ongoing off-line monitoring combined with online monitoring and coaching based on the
      self-determination theory.
More specifically, the primary objective of the RCT is to provide preliminary evidence
      regarding efficacy of the VirTele program for upper limb motor control recovery in chronic
      stroke. Secondary objectives are to: i. Determine the effect of the VirTele program on upper
      limb function, quality of life and motivation; ii. Determine the feasibility of using the
      VirTele program with users at home (e.g. adherence, safety, technical difficulties,
      facilitators and barriers); iii. Explore the role that shared decision-making and empowerment
      play in exercise program adherence and progression, and in behavior modification for
      upper-limb use.

      This study will also provide evidence of feasibility for conducting a larger-scale RCT
      comparing different technologies and interventions for chronic stroke rehabilitation.

      A single-blind (evaluator) two-arm randomized clinical trial (RCT) is proposed for this study
      with participants who have had a stroke randomly allocated to: (1) 8-week training with the
      VirTele system.i.e. treatment group or (2) 8-week written home exercise program provided by a
      clinician (GRASP), i.e. exercise control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE)
time frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
description: Upper limb motor control is assessed using a valid and reliable outcome, scores between 0-66, higher scores indicating better motor control. measure consisting of tasks to be performed by the participant
measure: Change from Baseline in Upper limb function at 8 weeks Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use
time frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
description: The Motor Activity Log is a questionnaire that the participant completes reporting how much the impaired upper limb is used for various daily tasks, each task is scored from 0-5 (ordinal scale, 0=do not use arm - 6=use as much as before), total score is mean of the scores.
measure: Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test
time frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
description: The Wolf Motor Function test consists of tasks that are performed by the participant with the impaired upper extremity, the tasks are rated for the quality of movement and the time taken. Items are scored on a 6 point scale, from does not attempt to movement is normal. Times tests are truncated at 120 seconds. A mean score out of a maximum of 5 is calculated.
measure: number of sessions (feasibility)
time frame: 8 weeks (ongoing)
description: number of sessions played (count)
measure: duration of sessions (Feasibility)
time frame: 8 weeks (ongoing)
description: average duration of sessions played (minutes)
measure: Amount of time spent on the actual exe games (moving the arm)
time frame: 8 weeks (ongoing)
description: amount of actual time spent using the impaired arm during the sessions (minutes)
measure: Frequency of on-line consultations with therapist
time frame: 8 weeks (ongoing)
description: Number of times real-time sessions are held between the therapist and the participant (online)
measure: duration (minutes) of on-line consultations with therapist
time frame: 8 weeks (ongoing)
description: average time spent by the therapist assisting for real-time sessions
measure: adverse event (counts)
time frame: 8 weeks (ongoing)
description: occurrence of adverse events (falls, motion sickness, dizziness, headaches) will be documented using a computerized patient log after each session.
measure: falls (count)
time frame: 8 weeks (ongoing)
description: occurrence of falls documented by the participant
measure: adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)
time frame: 8 weeks (ongoing)
description: self perceived exertion rated by the participant after the session (i.e. playing the exergame) on a scale 6-20, (no exertion to maximal exertion)
arm group label: No Intervention: Usual care
arm group type: Other
description: All study participants in the control group will receive an 8-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.
arm group label: Experimental: Telerehabilitation system
arm group type: Experimental
description: Participants in the experimental group will receive 8 weeks home exercise program using a virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and synchronously and the program adapted to ensure it remains at an appropriate level for the patient.
intervention type: Other
intervention name: home written exercise program
description: exercises such as picking up objects, placing objects, frequently prescribed at discharge
arm group label: No Intervention: Usual care
intervention type: Other
intervention name: telerehabilitation/exergame system
description: Video games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing
arm group label: Experimental: Telerehabilitation system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dahlia Kairy, PhD
role: Principal Investigator
affiliation: Université de Montréal
last name: Alejandro Hernandez, MSc
phone: 514-340-2085
email: alejandro.hernandez@mail.mcgill.ca
last name: Dahlia Kairy, phd
phone: 514-343-6301
email: dahlia.kairy@umontreal.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Montréal
investigator full name: Dahlia Kairy
investigator title: Associate Professor
mesh term: Stroke