<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/NCT04436770</url>
  </required_header>
  <id_info>
    <org_study_id>13/8.02.2018</org_study_id>
    <nct_id>NCT04436770</nct_id>
  </id_info>
  <brief_title>Medical Recovery and Social Reintegration for Post-stroke Patients Using Virtual Reality</brief_title>
  <official_title>Medical Recovery and Social Reintegration for Post-stroke Patients With Sequelae Using Virtual Reality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Transilvania University of Brasov</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spitalul Clinic de Psihiatrie si Neurologie Brasov</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Transilvania University of Brasov</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Application of Virtual Reality therapy and occupational therapy versus and standard&#xD;
      physiotherapy and occupational therapy to patients with post-stroke sequelae, using&#xD;
      specifical assessment tools, standard physiotherapy and occupational therapy programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Initial and final clinical and functional evaluation of patients with post-stroke&#xD;
           sequelae, storage and use of data obtained.&#xD;
&#xD;
        2. Collection and access of demographic and clinical data of patients included in the study&#xD;
           (respecting the principle of confidentiality and non-publication of personal data) only&#xD;
           by staff involved in the research project and working in the Clinical Hospital of&#xD;
           Psychiatry and Neurology in Brasov.&#xD;
&#xD;
        3. Application of Virtual Reality therapy and occupational therapy versus and standard&#xD;
           physiotherapy and occupational therapy to patients who meet the criteria for inclusion&#xD;
           in the study (scapulohumeral flexion and abduction of at least 20 degrees, elbow flexion&#xD;
           of at least 20 degrees, hip and knee flexion of at least 20 degrees, without severe&#xD;
           aphasia or severe behavioural/cognitive disorders).&#xD;
&#xD;
        4. Use of data obtained from the application of Virtual Reality therapy at home, through&#xD;
           Telerehabilitation, if patients procure alone or through sponsorship/donation the&#xD;
           equipment necessary to continue the Virtual Reality therapy program at home, taking into&#xD;
           account that the technology purchased through the project allows this.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Due to the COVID-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">July 18, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of patients for whom tailored Virtual Reality therapy is more efficient than standard tailored physiotherapy in the recovery of post-stroke sequelae.</measure>
    <time_frame>One year since the beginning of the research</time_frame>
    <description>Determining the factors and parameters that influence or enhance post-stroke recovery capacity using new recovery methods, such as non-immersive virtual reality.&#xD;
The assessment tools are: the Fugl-Meyer assessment for the upper extremity (FMUE), Fugl-Meyer assessment for the lower extremity (FMLE), the Modified Rankin Scale (MRS), the Functional Independence Measure (FIM), the Active Range of Motion (AROM), the Manual Muscle Testing (MMT), the Modified Ashworth Scale (MAS), the Functional Reach Test (FRT), and Timed Up and Go Test (TUG).&#xD;
The patients are assessed by recovery medical doctors (physiatrists) regarding FIM, MAS and MRS. While FMUE, FMLE, AROM, MMT, FRT, TUG are assessed by trained physiotherapists, with at least 5 years of experience in stroke sequelae physiotherapy and evaluation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of patients for whom heart disease and other elderly condition, age or gender are influencing the capacity to the recovery of post-stroke patients.</measure>
    <time_frame>One year since the beginning of the research</time_frame>
    <description>Collecting data related to age, gender, time after stroke, other conditions present (such as hypertension, dyslipidemia, diabetes, ischemic coronary disease, etc.) and determining the links between post-stroke recovery capacity and these factors using statistical software programs and analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Stroke Sequelae</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard physiotherapy and OT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual Reality Therapy and OT</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-immersive virtual reality therapy</intervention_name>
    <description>Non-immersive Virtual Reality (VR) therapy exercises, based on assessment, and occupational therapy exercises, for upper extremity or lower extremity.&#xD;
For the upper extremity, daily, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for upper extremity don't exceed 60 minutes.&#xD;
For the lower extremity, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for the lower extremity don't exceed 60 minutes.&#xD;
The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks.&#xD;
For the ankle and foot, analytical and dexterity exercises using Mirror therapy and alone were used.</description>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>Occupational therapy exercises</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Physiotherapy</intervention_name>
    <description>Standard physiotherapy program, based on assessment, plus occupational therapy exercises, for upper extremity or lower extremity.&#xD;
For the upper extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises.&#xD;
For the lower extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises.&#xD;
The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks.&#xD;
For the ankle and foot, analytical and dexterity exercises were used.</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Occupational therapy exercises</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. stroke survivors after the acute phase, at least 6 weeks post-stroke;&#xD;
&#xD;
          2. stroke survivors within no more than 4 years after stroke,&#xD;
&#xD;
          3. at least 30-degree flexion and scapulohumeral abduction against gravity.&#xD;
&#xD;
          4. elbow flexion of at least 30 degrees&#xD;
&#xD;
          5. hip flexion of at least 30 degrees&#xD;
&#xD;
          6. knee flexion of at least 30 degrees&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. no severe cognitive impairments,&#xD;
&#xD;
          2. no global or transcortical sensory aphasia,&#xD;
&#xD;
          3. no other dysfunctions in the upper extremity such as surgery, fractures, shoulder&#xD;
             arthritis or severe pain,&#xD;
&#xD;
          4. no other dysfunctions in the lower extremity such as surgery, fractures, arthritis or&#xD;
             severe pain,&#xD;
&#xD;
          5. without anaemia&#xD;
&#xD;
          6. without atrial fibrillation&#xD;
&#xD;
          7. without NYHA class IV heart failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Hospital of Psychiatry and Neurology</name>
      <address>
        <city>Braşov</city>
        <state>Brasov</state>
        <zip>500123</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Virtual Reality</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Recovery</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/NCT04436770
org study id: 13/8.02.2018
nct id: NCT04436770
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Application of Virtual Reality therapy and occupational therapy versus and standard
      physiotherapy and occupational therapy to patients with post-stroke sequelae, using
      specifical assessment tools, standard physiotherapy and occupational therapy programs.
1. Initial and final clinical and functional evaluation of patients with post-stroke
           sequelae, storage and use of data obtained.

        2. Collection and access of demographic and clinical data of patients included in the study
           (respecting the principle of confidentiality and non-publication of personal data) only
           by staff involved in the research project and working in the Clinical Hospital of
           Psychiatry and Neurology in Brasov.

        3. Application of Virtual Reality therapy and occupational therapy versus and standard
           physiotherapy and occupational therapy to patients who meet the criteria for inclusion
           in the study (scapulohumeral flexion and abduction of at least 20 degrees, elbow flexion
           of at least 20 degrees, hip and knee flexion of at least 20 degrees, without severe
           aphasia or severe behavioural/cognitive disorders).

        4. Use of data obtained from the application of Virtual Reality therapy at home, through
           Telerehabilitation, if patients procure alone or through sponsorship/donation the
           equipment necessary to continue the Virtual Reality therapy program at home, taking into
           account that the technology purchased through the project allows this.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: The number of patients for whom tailored Virtual Reality therapy is more efficient than standard tailored physiotherapy in the recovery of post-stroke sequelae.
time frame: One year since the beginning of the research
description: Determining the factors and parameters that influence or enhance post-stroke recovery capacity using new recovery methods, such as non-immersive virtual reality.
The assessment tools are: the Fugl-Meyer assessment for the upper extremity (FMUE), Fugl-Meyer assessment for the lower extremity (FMLE), the Modified Rankin Scale (MRS), the Functional Independence Measure (FIM), the Active Range of Motion (AROM), the Manual Muscle Testing (MMT), the Modified Ashworth Scale (MAS), the Functional Reach Test (FRT), and Timed Up and Go Test (TUG).
The patients are assessed by recovery medical doctors (physiatrists) regarding FIM, MAS and MRS. While FMUE, FMLE, AROM, MMT, FRT, TUG are assessed by trained physiotherapists, with at least 5 years of experience in stroke sequelae physiotherapy and evaluation.
measure: The number of patients for whom heart disease and other elderly condition, age or gender are influencing the capacity to the recovery of post-stroke patients.
time frame: One year since the beginning of the research
description: Collecting data related to age, gender, time after stroke, other conditions present (such as hypertension, dyslipidemia, diabetes, ischemic coronary disease, etc.) and determining the links between post-stroke recovery capacity and these factors using statistical software programs and analysis.
arm group label: Control Group
arm group type: Active Comparator
description: Standard physiotherapy and OT
arm group label: Experimental
arm group type: Experimental
description: Virtual Reality Therapy and OT
intervention type: Other
intervention name: Non-immersive virtual reality therapy
description: Non-immersive Virtual Reality (VR) therapy exercises, based on assessment, and occupational therapy exercises, for upper extremity or lower extremity.
For the upper extremity, daily, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for upper extremity don't exceed 60 minutes.
For the lower extremity, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for the lower extremity don't exceed 60 minutes.
The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks.
For the ankle and foot, analytical and dexterity exercises using Mirror therapy and alone were used.
arm group label: Experimental
other name: Occupational therapy exercises
intervention type: Other
intervention name: Standard Physiotherapy
description: Standard physiotherapy program, based on assessment, plus occupational therapy exercises, for upper extremity or lower extremity.
For the upper extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises.
For the lower extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises.
The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks.
For the ankle and foot, analytical and dexterity exercises were used.
arm group label: Control Group
other name: Occupational therapy exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Romania
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No