xml: <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/NCT05971420</url>
    </required_header>
    <id_info>
      <org_study_id>USQ AEC H21REA071</org_study_id>
      <nct_id>NCT05971420</nct_id>
    </id_info>
    <brief_title>Virtual Reality Activity-based Training for Preventing Falls for Older Adults With Mild Cognitive Impairment</brief_title>
    <acronym>MCI</acronym>
    <official_title>Virtual Reality Activity-based Training for Preventing Falls Among Community-dwelling Older Adults With Mild Cognitive Impairment: A Pilot Randomized Control Trial Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Southern Queensland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Hong Kong Polytechnic University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Southern Queensland</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>
        Using a Virtual Reality (VR) games-based application is as an innovative falls prevention&#xD;
        technology in an aged care service. The VR intervention has promising effects on improving&#xD;
        the physical and balance performances in the older adults.The study explored and evaluated&#xD;
        the effects of VR activity-based training on falls prevention among community-dwelling older&#xD;
        adults with mild cognitive impairment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A pilot randomized control trial study was applied to compare the effects on falls prevention&#xD;
        between participants who experienced a full-immersive VR training and group-based exercise&#xD;
        (Baduanjin) training. Eighteen participants were recruited from ausing convenience sampling&#xD;
        and were randomly assigned into the VR group and the exercise group (non-VR). The&#xD;
        participants in both wo groups' participants attended 16 falls prevention training sessions&#xD;
        over eight weeks. Eligible participants identified with a higher risk of mild cognitive&#xD;
        impairment and early dementia undertook three measurements, pretest (T1), post-test (T2) and&#xD;
        follow up (T3). The primary outcomes assessed included changes in physical risks factor of&#xD;
        falls, and the secondary outcomes assessed included changes in cognition and fall efficacy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2021</start_date>
    <completion_date type="Actual">January 15, 2022</completion_date>
    <primary_completion_date type="Actual">December 30, 2021</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>Health Services Research</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Berg balance test (BBS) - change is being assessed</measure>
      <time_frame>At prettest, postest (up to 8 weeks) and post 3 months follow up</time_frame>
      <description>To test the balance performance and assess the fall risk. Total score is 56 ( score below 51 indicated predictive of fall risk)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time up and go test (TUG) - change is being assessed</measure>
      <time_frame>At prettest, postest (up to 8 weeks) and post 3 months follow up</time_frame>
      <description>To assess functional mobility and assess the fall risk. Score over 12 seconds indicates higher risk of fall for the older adults</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Six minutes walk test (6MWT) - change is being assessed</measure>
      <time_frame>At prettest, postest (up to 8 weeks) and post 3 months follow up</time_frame>
      <description>To assess the walking speed and performance. Walking distance within 6 minutes measured the length (m/metre)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cognitive status assessed by Montreal Cognitive Assessment Scale- change is being assessed</measure>
      <time_frame>At prettest, postest (up to 8 weeks) and post 3 months follow up</time_frame>
      <description>To assess the cognitive level. Total score 30 ( score if less than 22 indicated higher risk of midl cognitive impairment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Executive functioning tests by Trail making test A and test B *TMTA/B) - change is being assessed</measure>
      <time_frame>At prettest, postest (up to 8 weeks) and post 3 months follow up</time_frame>
      <description>To assess the level of executive functions. It indicated the time of completion (second)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fall efficacy by fall efficacy international scale (FESI) - change is being assessed</measure>
      <time_frame>At prettest, postest (up to 8 weeks) and post 3 months follow up</time_frame>
      <description>To assess the level of fear concern. Totoal score is 64 (score lower than 27 indicated less fear concern</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">18</enrollment>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Fall Prevention</condition>
    <condition>Virtual Reality</condition>
    <condition>Exercise Training</condition>
    <arm_group>
      <arm_group_label>VR group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>VR activity-based training</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Exercise-based training (Baduanjin)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>VR activity-based</intervention_name>
      <description>VR games activities were chosen for simulated cognitive-motor training in the VR group. The VR training modules for this study included fire drill, walking exercise, balancing game activities and community shopping practices. These training modules involved dual task components; the participant was expected to train up his/her physical and cognitive motor performances in an 8-week VR activity-based program. VR group participants received 2-sessions per week, 16 training sessions in total.</description>
      <arm_group_label>VR group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise-based (Baduanjin)</intervention_name>
      <description>The exercise group used a traditional Chinese Qigong Baduanjin exercise incorporating with a fall prevention education strategy.</description>
      <arm_group_label>Exercise group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. aged 65 years to 85 years inclusive;&#xD;
  &#xD;
            2. had a history of a fall within the past 2 years;&#xD;
  &#xD;
            3. community-dwelling older adults;&#xD;
  &#xD;
            4. at a higher risk of mild cognitive impairment and dementia, assessed by a validated&#xD;
               screening tool of Hong Kong Montreal Cognitive assessment test (HK-MoCA score=21/22);&#xD;
  &#xD;
            5. walk independently e.g. able to access publicly - VR research center centre or local&#xD;
               community aged care facilities.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          if they had a medical diagnosis of unstable health conditions&#xD;
  &#xD;
            1. dizziness;&#xD;
  &#xD;
            2. Meniere's disease;&#xD;
  &#xD;
            3. Epilepsy;&#xD;
  &#xD;
            4. Parkinson's disease;&#xD;
  &#xD;
            5. Severe hearing impairment and visual impairments;&#xD;
  &#xD;
            6. Mental illness.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>WING KEUNG IP</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Southern Queensland</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>The Hong Kong Polytechnic University, St. James Settlement Hong Kong, Salvation Army Hong Kong</name>
        <address>
          <city>Hong Kong</city>
          <state>China</state>
          <zip>0000</zip>
          <country>Hong Kong</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Fall risk</keyword>
    <keyword>VR</keyword>
    <keyword>MCI</keyword>
    <keyword>Ageing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No permission from participants</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971420
  org study id: USQ AEC H21REA071
  nct id: NCT05971420
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Using a Virtual Reality (VR) games-based application is as an innovative falls prevention
        technology in an aged care service. The VR intervention has promising effects on improving
        the physical and balance performances in the older adults.The study explored and evaluated
        the effects of VR activity-based training on falls prevention among community-dwelling older
        adults with mild cognitive impairment.
  A pilot randomized control trial study was applied to compare the effects on falls prevention
        between participants who experienced a full-immersive VR training and group-based exercise
        (Baduanjin) training. Eighteen participants were recruited from ausing convenience sampling
        and were randomly assigned into the VR group and the exercise group (non-VR). The
        participants in both wo groups' participants attended 16 falls prevention training sessions
        over eight weeks. Eligible participants identified with a higher risk of mild cognitive
        impairment and early dementia undertook three measurements, pretest (T1), post-test (T2) and
        follow up (T3). The primary outcomes assessed included changes in physical risks factor of
        falls, and the secondary outcomes assessed included changes in cognition and fall efficacy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Berg balance test (BBS) - change is being assessed
  time frame: At prettest, postest (up to 8 weeks) and post 3 months follow up
  description: To test the balance performance and assess the fall risk. Total score is 56 ( score below 51 indicated predictive of fall risk)
  measure: Time up and go test (TUG) - change is being assessed
  time frame: At prettest, postest (up to 8 weeks) and post 3 months follow up
  description: To assess functional mobility and assess the fall risk. Score over 12 seconds indicates higher risk of fall for the older adults
  measure: Six minutes walk test (6MWT) - change is being assessed
  time frame: At prettest, postest (up to 8 weeks) and post 3 months follow up
  description: To assess the walking speed and performance. Walking distance within 6 minutes measured the length (m/metre)
  measure: Cognitive status assessed by Montreal Cognitive Assessment Scale- change is being assessed
  time frame: At prettest, postest (up to 8 weeks) and post 3 months follow up
  description: To assess the cognitive level. Total score 30 ( score if less than 22 indicated higher risk of midl cognitive impairment
  measure: Executive functioning tests by Trail making test A and test B *TMTA/B) - change is being assessed
  time frame: At prettest, postest (up to 8 weeks) and post 3 months follow up
  description: To assess the level of executive functions. It indicated the time of completion (second)
  measure: Fall efficacy by fall efficacy international scale (FESI) - change is being assessed
  time frame: At prettest, postest (up to 8 weeks) and post 3 months follow up
  description: To assess the level of fear concern. Totoal score is 64 (score lower than 27 indicated less fear concern
  arm group label: VR group
  arm group type: Experimental
  description: VR activity-based training
  arm group label: Exercise group
  arm group type: Active Comparator
  description: Exercise-based training (Baduanjin)
  intervention type: Other
  intervention name: VR activity-based
  description: VR games activities were chosen for simulated cognitive-motor training in the VR group. The VR training modules for this study included fire drill, walking exercise, balancing game activities and community shopping practices. These training modules involved dual task components; the participant was expected to train up his/her physical and cognitive motor performances in an 8-week VR activity-based program. VR group participants received 2-sessions per week, 16 training sessions in total.
  arm group label: VR group
  intervention type: Other
  intervention name: Exercise-based (Baduanjin)
  description: The exercise group used a traditional Chinese Qigong Baduanjin exercise incorporating with a fall prevention education strategy.
  arm group label: Exercise group
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: WING KEUNG IP
  role: Principal Investigator
  affiliation: University of Southern Queensland
  facility: 
  country: Hong Kong
  responsible party type: Sponsor
  mesh term: Cognitive Dysfunction
  sharing ipd: No
  ipd description: No permission from participants