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/NCT05965661</url>
    </required_header>
    <id_info>
      <org_study_id>2022-01545</org_study_id>
      <nct_id>NCT05965661</nct_id>
    </id_info>
    <brief_title>A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease</brief_title>
    <official_title>A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease: a Randomized Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Luzerner Kantonsspital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Luzerner Kantonsspital</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>
        We investigate the impact of a 4-week virtual reality-based upper limb training in&#xD;
        Parkinson's disease. The benefits on dexterity of this training program will be evaluated.&#xD;
  &#xD;
        For these purposes, a randomised, two arm, single assessor blind, parallel design with a&#xD;
        monocentric, study setup will be performed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with Parkinson's disease (PD) suffer from significantly decreased coordination and&#xD;
        have difficulties with precise hand/finger movements during the performance of both basic&#xD;
        activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as&#xD;
        cooking, shopping and regular medication intake. These difficulties further add to the burden&#xD;
        of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly&#xD;
        growing aspect of training in PD neurorehabilitation offers virtual reality (VR). We explore&#xD;
        the effects of a VR-based upper limb hand training compared to a VR control training, which&#xD;
        is less specific for dexterity. Moreover, we examine the effetcs of the trainings on upper&#xD;
        limb related ADL, and therefore the impact on QoL in patients with PD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 19, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>
      <intervention_model_description>Randomized pilot study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>VR upper limb hand training or VR control training</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>fine finger movements</measure>
      <time_frame>4 weeks</time_frame>
      <description>Coin rotation task (CRT): The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD. The seconds for 20 halfturns will be measured.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>hand dexterity</measure>
      <time_frame>4 weeks</time_frame>
      <description>Nine Hole Peg test (9-HPT): The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD. seconds will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>grip strenght</measure>
      <time_frame>4 weeks</time_frame>
      <description>The handheld JAMAR dynamometer measures the grip strength. kg will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>motor function</measure>
      <time_frame>4 weeks</time_frame>
      <description>MDS-Sponsored Revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS III): It evaluates motor aspects of Parkinson's disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>self-reported dexterity related problems in daily living</measure>
      <time_frame>4 weeks</time_frame>
      <description>Dexterity Questionnaire 24 (DextQ-24): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD. score range 24-96, higher scores mean more dexterity problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>self-reported problems in quality of life</measure>
      <time_frame>4 weeks</time_frame>
      <description>Parkinson's Disease Questionnaire (PDQ-39): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating QOL in PD. range 0-156, higher values mean more problems.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Virtual reality upper limb hand training</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Virtual reality control training</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The PD patients randomized in the control group will receive virtual reality control training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>virtual reality upper limb hand training</intervention_name>
      <description>The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.</description>
      <arm_group_label>Virtual reality upper limb hand training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>virtual reality control training</intervention_name>
      <description>The PD patients randomized in the control group will receive virtual reality control training.</description>
      <arm_group_label>Virtual reality control training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with confirmed PD, according to UK Brain bank Criteria&#xD;
  &#xD;
            -  Hoehn &amp; Yahr Stadium I to IV&#xD;
  &#xD;
            -  Age 40 to 99 years&#xD;
  &#xD;
            -  written and signed informed consent&#xD;
  &#xD;
            -  self-reported dexterous difficulties&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  MoCA &lt;21/30&#xD;
  &#xD;
            -  psychiatric disease&#xD;
  &#xD;
            -  participation on other interventional trials&#xD;
  &#xD;
            -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
               psychological disorders, dementia, etc.&#xD;
  &#xD;
            -  severe visual impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tim Vanbellingen, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Luzerner Kantonsspital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cornelia Cox, MSc</last_name>
      <phone>041 205 56 80</phone>
      <email>cornelia.cox@luks.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Manuela Pastore, PhD</last_name>
      <phone>041 205 72 20</phone>
      <email>manuela.pastore@luks.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Luzerner Kantonsspital</name>
        <address>
          <city>Lucerne</city>
          <zip>6000</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Manuela Pastore, PhD</last_name>
        <phone>0412057220</phone>
        <email>manuela.pastore@luks.ch</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Parkinson Disease</keyword>
    <keyword>virtual reality training</keyword>
    <keyword>dexterity</keyword>
    <keyword>Parkinsonian Disorders</keyword>
    <keyword>Basal Ganglia Diseases</keyword>
    <keyword>Brain Diseases</keyword>
    <keyword>Central Nervous System Diseases</keyword>
    <keyword>Nervous System Diseases</keyword>
    <keyword>Movement Disorders</keyword>
    <keyword>Neurodegenerative Diseases</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05965661
  org study id: 2022-01545
  nct id: NCT05965661
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  We investigate the impact of a 4-week virtual reality-based upper limb training in
        Parkinson's disease. The benefits on dexterity of this training program will be evaluated.
  
        For these purposes, a randomised, two arm, single assessor blind, parallel design with a
        monocentric, study setup will be performed.
  Patients with Parkinson's disease (PD) suffer from significantly decreased coordination and
        have difficulties with precise hand/finger movements during the performance of both basic
        activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as
        cooking, shopping and regular medication intake. These difficulties further add to the burden
        of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly
        growing aspect of training in PD neurorehabilitation offers virtual reality (VR). We explore
        the effects of a VR-based upper limb hand training compared to a VR control training, which
        is less specific for dexterity. Moreover, we examine the effetcs of the trainings on upper
        limb related ADL, and therefore the impact on QoL in patients with PD.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized pilot study
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: VR upper limb hand training or VR control training
  measure: fine finger movements
  time frame: 4 weeks
  description: Coin rotation task (CRT): The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD. The seconds for 20 halfturns will be measured.
  measure: hand dexterity
  time frame: 4 weeks
  description: Nine Hole Peg test (9-HPT): The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD. seconds will be measured.
  measure: grip strenght
  time frame: 4 weeks
  description: The handheld JAMAR dynamometer measures the grip strength. kg will be measured.
  measure: motor function
  time frame: 4 weeks
  description: MDS-Sponsored Revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS III): It evaluates motor aspects of Parkinson's disease
  measure: self-reported dexterity related problems in daily living
  time frame: 4 weeks
  description: Dexterity Questionnaire 24 (DextQ-24): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD. score range 24-96, higher scores mean more dexterity problems.
  measure: self-reported problems in quality of life
  time frame: 4 weeks
  description: Parkinson's Disease Questionnaire (PDQ-39): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating QOL in PD. range 0-156, higher values mean more problems.
  arm group label: Virtual reality upper limb hand training
  arm group type: Other
  description: The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.
  arm group label: Virtual reality control training
  arm group type: Other
  description: The PD patients randomized in the control group will receive virtual reality control training.
  intervention type: Other
  intervention name: virtual reality upper limb hand training
  description: The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.
  arm group label: Virtual reality upper limb hand training
  intervention type: Other
  intervention name: virtual reality control training
  description: The PD patients randomized in the control group will receive virtual reality control training.
  arm group label: Virtual reality control training
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Tim Vanbellingen, Prof
  role: Principal Investigator
  affiliation: Luzerner Kantonsspital
  last name: Cornelia Cox, MSc
  phone: 041 205 56 80
  email: cornelia.cox@luks.ch
  last name: Manuela Pastore, PhD
  phone: 041 205 72 20
  email: manuela.pastore@luks.ch
  facility: 
  status: Recruiting
  contact: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  sharing ipd: No