<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/NCT03759145</url>
  </required_header>
  <id_info>
    <org_study_id>CRIR-795-0113</org_study_id>
    <nct_id>NCT03759145</nct_id>
  </id_info>
  <brief_title>The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke</brief_title>
  <official_title>The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 disability worldwide.Hemiplegia, weakness of one side&#xD;
      of the body, is a common consequence of stroke that can lead to significant functional&#xD;
      impairments. Loss of arm function occurs in up to 85% of stroke survivors. The impact of&#xD;
      arm-related limitations on activities of daily living, leisure activities or work is&#xD;
      significant as the arm plays a central role in a person's life from the ability to perform&#xD;
      basic activities of daily life to carrying out family and social roles. Guidelines indicate&#xD;
      that rehabilitation can improve upper extremity (UE) motor control and functional status post&#xD;
      stroke. Virtual reality (VR) and computer games are recent technologies that, as they become&#xD;
      more accessible and affordable,are increasingly being used in rehabilitation to allow&#xD;
      patients to engage in repetitive practice of specific tasks. A number of published reviews&#xD;
      and meta-analyses have examined the use of VR and video games for post-stroke rehabilitation,&#xD;
      focusing on or including UE rehabilitation. The authors agree that there is limited but&#xD;
      promising findings that VR and video-games, when combined with traditional rehabilitation,&#xD;
      have a positive impact on recovery post-stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the study is to assess the feasibility, safety, and acceptability of the&#xD;
      Jintronix system, as well as provide preliminary evidence regarding the clinical efficacy for&#xD;
      post-stroke rehabilitation.This is a pilot parallel randomised single-blinded controlled&#xD;
      trial, with patients who have had a stroke randomly allocated to one of two groups: (1) usual&#xD;
      rehabilitation services and additional training with Jintronix system (treatment group) or&#xD;
      (2) usual rehabilitation services only (control group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>number of sessions (feasibility)</measure>
    <time_frame>4 week period</time_frame>
    <description>number of sessions the participant used the system during the study period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>duration of sessions</measure>
    <time_frame>4 week period (ongoing)</time_frame>
    <description>the average duration of sessions (minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time spent by therapist assisting the participant</measure>
    <time_frame>4 week period (ongoing)</time_frame>
    <description>time during the sessions that the therapist spent assisting the participant (minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time spent on each exergame</measure>
    <time_frame>4 week period (ongoing)</time_frame>
    <description>the time spent on each exergame (minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adverse event (counts)</measure>
    <time_frame>4 week period (ongoing)</time_frame>
    <description>occurrence of adverse events such as falls, motion sickness, dizziness and headaches</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adverse event (borg exertion scale, self-reported scale 6-20, (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)</measure>
    <time_frame>4 week period (ongoing)</time_frame>
    <description>exertion after playing the exergame reported using the Borg Exertion Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adverse event (pain self reported on visual analog scale 0-10)</measure>
    <time_frame>4 week period (ongoing)</time_frame>
    <description>pain after playing the exergame reported using visual analog scale 0-10, 0 is no pain, 10 is the worse pain imaginable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke-specific measure of quality of life - Stroke Impact Scale</measure>
    <time_frame>4 week period (per-post)</time_frame>
    <description>Stroke Impact Scale is a questionnaire of the impact that the stroke is having on function, mood, emotional status, total score 0-100, with with higher scores indicating better self-reported health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>upper limb function assessed using the Motor Activity Log</measure>
    <time_frame>4 week period (per-post)</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>
  </primary_outcome>
  <primary_outcome>
    <measure>upper limb function assessed using the Box and Block test</measure>
    <time_frame>4 week period (per-post)</time_frame>
    <description>upper limb function is assessed using the box and block test where participants are timed while picking up and placing wooden cubes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>upper limb motor control assessed using the Fugl-Meyer Assessment-upper extremity</measure>
    <time_frame>4 week period (per-post)</time_frame>
    <description>Upper limb motor control is assessed using a valid and reliable outcome, measure consisting of tasks to be performed by the participant, scores between 0-66, higher scores indicating better motor control.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Intervention arm, usual rehabilitation + Jintronix exergame</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On top of the usual out-patient rehabilitation sessions planned for the participant, participants attend sessions to use the Jintronix system for up 30 minutes up to 3 times per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants continue their prescribed rehabilitation sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exergame</intervention_name>
    <description>Participants use exergame with the therapist in the rehabilitation center. Several games are available, the therapist adjusts the choice of game and level of difficulty according to the participant's abilities and interests.</description>
    <arm_group_label>Intervention arm, usual rehabilitation + Jintronix exergame</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual care</intervention_name>
    <description>participants continued their planned rehabilitation sessions</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having had an ischemic or hemorrhagic stroke for the first time;&#xD;
&#xD;
          -  having residual mild to moderate UE impairment (score 3-6 on the Chedoke-McMaster arm&#xD;
             component, as long as exergames can be played);&#xD;
&#xD;
          -  being in subacute stage (within 6 months post-stroke);&#xD;
&#xD;
          -  receiving usual out-patient rehabilitation services at one of the two selected&#xD;
             rehabilitation sites, located in the greater Montreal area in Canada.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being medically unstable;&#xD;
&#xD;
          -  having severe cognitive or communication deficits;&#xD;
&#xD;
          -  having visual impairments limiting use of the exergame;&#xD;
&#xD;
          -  having any medical contraindication for shoulder movements;&#xD;
&#xD;
          -  having severe balance deficits limiting sitting safely independently;&#xD;
&#xD;
          -  having previous upper limb impairment limiting potential recovery;&#xD;
&#xD;
          -  having any other impairment that limited use of the exergame.&#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>Université de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3N 1X7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</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 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</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>exergame</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>
  <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/NCT03759145
org study id: CRIR-795-0113
nct id: NCT03759145
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke is a leading cause of death and disability worldwide.Hemiplegia, weakness of one side
      of the body, is a common consequence of stroke that can lead to significant functional
      impairments. Loss of arm function occurs in up to 85% of stroke survivors. The impact of
      arm-related limitations on activities of daily living, leisure activities or work is
      significant as the arm plays a central role in a person's life from the ability to perform
      basic activities of daily life to carrying out family and social roles. Guidelines indicate
      that rehabilitation can improve upper extremity (UE) motor control and functional status post
      stroke. Virtual reality (VR) and computer games are recent technologies that, as they become
      more accessible and affordable,are increasingly being used in rehabilitation to allow
      patients to engage in repetitive practice of specific tasks. A number of published reviews
      and meta-analyses have examined the use of VR and video games for post-stroke rehabilitation,
      focusing on or including UE rehabilitation. The authors agree that there is limited but
      promising findings that VR and video-games, when combined with traditional rehabilitation,
      have a positive impact on recovery post-stroke.
The goal of the study is to assess the feasibility, safety, and acceptability of the
      Jintronix system, as well as provide preliminary evidence regarding the clinical efficacy for
      post-stroke rehabilitation.This is a pilot parallel randomised single-blinded controlled
      trial, with patients who have had a stroke randomly allocated to one of two groups: (1) usual
      rehabilitation services and additional training with Jintronix system (treatment group) or
      (2) usual rehabilitation services only (control group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: number of sessions (feasibility)
time frame: 4 week period
description: number of sessions the participant used the system during the study period
measure: duration of sessions
time frame: 4 week period (ongoing)
description: the average duration of sessions (minutes)
measure: time spent by therapist assisting the participant
time frame: 4 week period (ongoing)
description: time during the sessions that the therapist spent assisting the participant (minutes)
measure: time spent on each exergame
time frame: 4 week period (ongoing)
description: the time spent on each exergame (minutes)
measure: adverse event (counts)
time frame: 4 week period (ongoing)
description: occurrence of adverse events such as falls, motion sickness, dizziness and headaches
measure: adverse event (borg exertion scale, self-reported scale 6-20, (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)
time frame: 4 week period (ongoing)
description: exertion after playing the exergame reported using the Borg Exertion Scale
measure: adverse event (pain self reported on visual analog scale 0-10)
time frame: 4 week period (ongoing)
description: pain after playing the exergame reported using visual analog scale 0-10, 0 is no pain, 10 is the worse pain imaginable.
measure: Stroke-specific measure of quality of life - Stroke Impact Scale
time frame: 4 week period (per-post)
description: Stroke Impact Scale is a questionnaire of the impact that the stroke is having on function, mood, emotional status, total score 0-100, with with higher scores indicating better self-reported health.
measure: upper limb function assessed using the Motor Activity Log
time frame: 4 week period (per-post)
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: upper limb function assessed using the Box and Block test
time frame: 4 week period (per-post)
description: upper limb function is assessed using the box and block test where participants are timed while picking up and placing wooden cubes
measure: upper limb motor control assessed using the Fugl-Meyer Assessment-upper extremity
time frame: 4 week period (per-post)
description: Upper limb motor control is assessed using a valid and reliable outcome, measure consisting of tasks to be performed by the participant, scores between 0-66, higher scores indicating better motor control.
arm group label: Intervention arm, usual rehabilitation + Jintronix exergame
arm group type: Experimental
description: On top of the usual out-patient rehabilitation sessions planned for the participant, participants attend sessions to use the Jintronix system for up 30 minutes up to 3 times per week
arm group label: Control group
arm group type: Other
description: Participants continue their prescribed rehabilitation sessions
intervention type: Other
intervention name: Exergame
description: Participants use exergame with the therapist in the rehabilitation center. Several games are available, the therapist adjusts the choice of game and level of difficulty according to the participant's abilities and interests.
arm group label: Intervention arm, usual rehabilitation + Jintronix exergame
intervention type: Other
intervention name: usual care
description: participants continued their planned rehabilitation sessions
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Montréal
investigator full name: Dahlia Kairy
investigator title: Associate professor
mesh term: Stroke
sharing ipd: No