<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/NCT04443127</url>
  </required_header>
  <id_info>
    <org_study_id>JRizvi</org_study_id>
    <nct_id>NCT04443127</nct_id>
  </id_info>
  <brief_title>Virtual Reality as a Motor Priming Tool for Cognitive-Motor Rehabilitation Among Sub-Acute Stroke Patients</brief_title>
  <official_title>Virtual Reality as a Motor Priming Tool for Cognitive-Motor Rehabilitation Among Sub-Acute Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziauddin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziauddin University</source>
  <oversight_info>
    <has_dmc>Yes</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 the second leading global cause of mortality counting for 6.5 million deaths per&#xD;
      annum. The global prevalence of stroke is increasing with an estimated prevalence of 33&#xD;
      million per year, affecting 1 out of 6 individuals during their lifetime. The international&#xD;
      data suggests the overall economic burden in Asia is projected to be increased to 1.3 Billion&#xD;
      by 2050. Therefore, the appropriate and timely stroke intervention is required to save&#xD;
      healthcare costs and reduce the burden of the disease. Studies have reported the&#xD;
      effectiveness of VR intervention not only in cognitive abilities but it has found to be&#xD;
      simultaneously effective in improving other domains as attention and coordination with motor&#xD;
      retraining. VR combined with a newly developed concept of motor priming has shown encouraging&#xD;
      results in improving motor control and task execution in stroke patients. Further studies are&#xD;
      needed to analyze the impact of motor priming with VR in stroke patients on varied&#xD;
      neurological domains; hence the present study aims to investigate the impact of VR based&#xD;
      motor priming on sensorimotor, functional and cognitive outcomes among sub-acute stroke&#xD;
      patients rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total 62 patients will be recruited in the study. After voluntary consent, all the patients&#xD;
      will be randomly divided into Group-A and B through the envelope method of simple random&#xD;
      sampling. Patients in Group-A will be receiving VR based motor priming intervention while&#xD;
      Group-B patients will be receiving Motor-Relearning Program as conventional therapy. Whereas,&#xD;
      both the groups will be given 16 sessions of their respective protocol, comprising of 45&#xD;
      minutes, 4 times/week for the duration of 4 weeks. Pre and post assessment will be performed&#xD;
      for each patient on all three quantitative outcome measures i.e. FMA-UE, CAHAI-13, and MoCA.&#xD;
      A trial will be terminated, if the patient reported fatigue of &gt;8 out of 10 on the Visual&#xD;
      Analogue Scale, unable to execute movements, reports pain, eye strain, or signs of volitional&#xD;
      fatigue in hemiplegic or non-hemiplegic extremities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">October 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensorimotor function of hemiplegic upper extremity (Pre-Treatment)</measure>
    <time_frame>Baseline</time_frame>
    <description>Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensorimotor function of hemiplegic upper extremity (Post-Treatment)</measure>
    <time_frame>After 4 weeks</time_frame>
    <description>Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional ability of hemiplegic upper extremity (Pre-Treatment)</measure>
    <time_frame>Baseline</time_frame>
    <description>Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional ability of hemiplegic upper extremity (Post-Treatment)</measure>
    <time_frame>After 4 weeks</time_frame>
    <description>Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Function (Pre-Treatment)</measure>
    <time_frame>Baseline</time_frame>
    <description>Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive Function (Post-Treatment)</measure>
    <time_frame>After 4 weeks</time_frame>
    <description>Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Game-Based Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Rehabilitation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality Training Session</intervention_name>
    <description>VR based motor priming intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.</description>
    <arm_group_label>Game-Based Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motor-Relearning Program</intervention_name>
    <description>Motor-Relearning Program intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.</description>
    <arm_group_label>Conventional Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female stroke patients aged 25-65 years&#xD;
&#xD;
          -  Patients who had an ischemic or hemorrhagic stroke in sub-acute phase of &lt; 3 months&#xD;
&#xD;
          -  Mild cognitive impairment i.e. &lt; 26 (19.0-25.2) on MoCA&#xD;
&#xD;
          -  Minimum Scoring of 28 in the Motricity Index&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed visual-perceptual ailments which may restrict task execution&#xD;
&#xD;
          -  Communication disorders such as aphasia or dysarthria which may impede cognitive&#xD;
             assessment&#xD;
&#xD;
          -  Comorbidities such as elevated blood pressure (&gt;160mmhg/105 mmHg), heart diseases or&#xD;
             chronic medical conditions&#xD;
&#xD;
          -  Major or active psychological illness and pre-existing dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jaza Rizvi</last_name>
    <phone>36629251</phone>
    <phone_ext>5</phone_ext>
    <email>jaza.rizvi@zu.edu.pk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ziauddin University</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaza Rizvi</last_name>
      <phone>36629251</phone>
      <phone_ext>5</phone_ext>
      <email>jaza.rizvi@zu.edu.pk</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 20, 2020</last_update_submitted>
  <last_update_submitted_qc>June 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ziauddin University</investigator_affiliation>
    <investigator_full_name>Jaza Rizvi</investigator_full_name>
    <investigator_title>Principal Invesitgator</investigator_title>
  </responsible_party>
  <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/NCT04443127
org study id: JRizvi
nct id: NCT04443127
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Stroke is the second leading global cause of mortality counting for 6.5 million deaths per
      annum. The global prevalence of stroke is increasing with an estimated prevalence of 33
      million per year, affecting 1 out of 6 individuals during their lifetime. The international
      data suggests the overall economic burden in Asia is projected to be increased to 1.3 Billion
      by 2050. Therefore, the appropriate and timely stroke intervention is required to save
      healthcare costs and reduce the burden of the disease. Studies have reported the
      effectiveness of VR intervention not only in cognitive abilities but it has found to be
      simultaneously effective in improving other domains as attention and coordination with motor
      retraining. VR combined with a newly developed concept of motor priming has shown encouraging
      results in improving motor control and task execution in stroke patients. Further studies are
      needed to analyze the impact of motor priming with VR in stroke patients on varied
      neurological domains; hence the present study aims to investigate the impact of VR based
      motor priming on sensorimotor, functional and cognitive outcomes among sub-acute stroke
      patients rehabilitation.
A total 62 patients will be recruited in the study. After voluntary consent, all the patients
      will be randomly divided into Group-A and B through the envelope method of simple random
      sampling. Patients in Group-A will be receiving VR based motor priming intervention while
      Group-B patients will be receiving Motor-Relearning Program as conventional therapy. Whereas,
      both the groups will be given 16 sessions of their respective protocol, comprising of 45
      minutes, 4 times/week for the duration of 4 weeks. Pre and post assessment will be performed
      for each patient on all three quantitative outcome measures i.e. FMA-UE, CAHAI-13, and MoCA.
      A trial will be terminated, if the patient reported fatigue of >8 out of 10 on the Visual
      Analogue Scale, unable to execute movements, reports pain, eye strain, or signs of volitional
      fatigue in hemiplegic or non-hemiplegic extremities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Sensorimotor function of hemiplegic upper extremity (Pre-Treatment)
time frame: Baseline
description: Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function
measure: Sensorimotor function of hemiplegic upper extremity (Post-Treatment)
time frame: After 4 weeks
description: Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function
measure: Functional ability of hemiplegic upper extremity (Pre-Treatment)
time frame: Baseline
description: Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability
measure: Functional ability of hemiplegic upper extremity (Post-Treatment)
time frame: After 4 weeks
description: Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability
measure: Cognitive Function (Pre-Treatment)
time frame: Baseline
description: Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function
measure: Cognitive Function (Post-Treatment)
time frame: After 4 weeks
description: Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function
arm group label: Game-Based Rehabilitation
arm group type: Experimental
arm group label: Conventional Rehabilitation
arm group type: Placebo Comparator
intervention type: Device
intervention name: Virtual Reality Training Session
description: VR based motor priming intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.
arm group label: Game-Based Rehabilitation
intervention type: Behavioral
intervention name: Motor-Relearning Program
description: Motor-Relearning Program intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.
arm group label: Conventional Rehabilitation
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jaza Rizvi
phone: 36629251
phone ext: 5
email: jaza.rizvi@zu.edu.pk
facility: 
status: Recruiting
contact: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Ziauddin University
investigator full name: Jaza Rizvi
investigator title: Principal Invesitgator
mesh term: Stroke
sharing ipd: No