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/NCT05982730</url>
    </required_header>
    <id_info>
      <org_study_id>46179</org_study_id>
      <nct_id>NCT05982730</nct_id>
    </id_info>
    <brief_title>SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease</brief_title>
    <acronym>SegwayPD</acronym>
    <official_title>SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas Southwestern Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Texas Southwestern Medical Center</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>
        The purpose of this study is to examine the safety and efficacy of postural training&#xD;
        emphasized on the integration of multiple sensory information into motor control in&#xD;
        individuals with PD. This project is a proof-of-concept study to assess the effectiveness of&#xD;
        postural training using Segway, which serves a platform to provide augmented and continuous&#xD;
        proprioceptive and visuospatial information during postural training.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to examine the safety and efficacy of postural training&#xD;
        emphasized on the integration of multiple sensory information into motor control in&#xD;
        individuals with PD (Parkinson's disease). This project is a proof-of-concept study to assess&#xD;
        the effectiveness of postural training using Segway, which serves a platform to provide&#xD;
        augmented and continuous proprioceptive and visuospatial information during postural&#xD;
        training. Specifically, we will measure postural sway during quiet standing, single and&#xD;
        dual-task walking performances, and brain activation during single and dual-task walking from&#xD;
        the regions involved in planning and execution of locomotion; these include dorsolateral&#xD;
        prefrontal cortex, premotor cortex and primary motor cortex. The changes in visuospatial&#xD;
        function and proprioception after training will also be assessed. Individuals with moderate&#xD;
        disease stage of PD exhibiting postural instability will be recruited. The participants will&#xD;
        receive 1-week training and be assessed at 3 time points: 1-week before, before, and after&#xD;
        the training.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 31, 2023</start_date>
    <completion_date type="Anticipated">July 14, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 14, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline postural sway at week 3</measure>
      <time_frame>Week 1 (2 assessments), Week 3 (1assessment)</time_frame>
      <description>The midpoint between the tip of left and right calcaneus bones is considered as the origin of the reference system of the center of pressure (CoP). The CoP displacement along lateral and anterior-posterior axes are measured. The overall size of postural sways will be estimated from the ellipse area conveying 85% of the total CoP samples. The postural sway obtained from 2 assessments during week 1 will be averaged and used as baseline value. The postural sway obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Feasibility of Segway training</measure>
      <time_frame>Week 3 (1 assessment)</time_frame>
      <description>The attendance of training session for each participant will be used to assess the feasibility of the 1-week postural training. Adherence above 80% will indicate that the participants receive the training well.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline gait spatiotemporal parameters at week 3</measure>
      <time_frame>Week 1 (2 assessments), Week 3 (1assessment)</time_frame>
      <description>Spatiotemporal parameters will be used to characterized walking in dual task and single task conditions. One gait cycle will be defined as period from heel strike to the consecutive heel strike of the ipsilateral leg. The gait's spatiotemporal parameters obtained from 2 assessments during week 1 will be averaged and used as baseline value. The gait's spatiotemporal parameters obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline EEG spectral ratio at week 3</measure>
      <time_frame>Week 1 (2 assessments), Week 3 (1assessment)</time_frame>
      <description>The absolute powers in delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), and beta (13 - 30 Hz) frequency bands obtained using Fast Fourier Transform will be used to calculate the spectral ratio of the frequency bands. The spectral ratio is defined as ratio of the sum of absolute powers in the alpha and beta bands divided by the sum of the absolute power in the delta and theta frequency bands. The spectral ratio obtained from 2 assessments during week 1 will be averaged and used as baseline value. The spectral ratio obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>PD - individuals with Parkinson Disease, either male or female</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals, aged 50-85, with a clinical diagnosis of idiopathic Parkinson Disease, either male or female, with moderate disease stage presenting balance alterations (Hoehn or Yahr stage III)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Sensory-Augmented Postural Training</intervention_name>
      <description>To examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control and to assess the effectiveness of postural training using Segway</description>
      <arm_group_label>PD - individuals with Parkinson Disease, either male or female</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  a clinical diagnosis of idiopathic PD with moderate disease stage presenting balance&#xD;
               alterations (Hoehn and Yahr stage III)&#xD;
  &#xD;
            -  being stable on medication for at least 1 month&#xD;
  &#xD;
            -  the ability to stand and walk unsupported for 5 min both on and off medication&#xD;
  &#xD;
            -  age between 50 and 85&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  neurological disorders other than PD&#xD;
  &#xD;
            -  major unstable medical illnesses&#xD;
  &#xD;
            -  sensory or musculoskeletal disorders (e.g., diabetes, uncorrected visual problems,&#xD;
               arthritis, severe hearing impairments) that will prohibit the ability to perform the&#xD;
               assessment tests and receive training&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yasin Dhaher, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Texas Southwestern Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yu-Chen Chung, PT, Ph.D.</last_name>
      <phone>214-648-8838</phone>
      <email>yu-chen.chung@utsouthwestern.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Subaryani Soedirdjo, Ph.D.</last_name>
      <email>subaryani.soedirdjo@utsouthwestern.edu</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
      <investigator_full_name>Yasin Dhaher</investigator_full_name>
      <investigator_title>Professor of Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <!-- 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/NCT05982730
  org study id: 46179
  nct id: NCT05982730
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to examine the safety and efficacy of postural training
        emphasized on the integration of multiple sensory information into motor control in
        individuals with PD. This project is a proof-of-concept study to assess the effectiveness of
        postural training using Segway, which serves a platform to provide augmented and continuous
        proprioceptive and visuospatial information during postural training.
  The purpose of this study is to examine the safety and efficacy of postural training
        emphasized on the integration of multiple sensory information into motor control in
        individuals with PD (Parkinson's disease). This project is a proof-of-concept study to assess
        the effectiveness of postural training using Segway, which serves a platform to provide
        augmented and continuous proprioceptive and visuospatial information during postural
        training. Specifically, we will measure postural sway during quiet standing, single and
        dual-task walking performances, and brain activation during single and dual-task walking from
        the regions involved in planning and execution of locomotion; these include dorsolateral
        prefrontal cortex, premotor cortex and primary motor cortex. The changes in visuospatial
        function and proprioception after training will also be assessed. Individuals with moderate
        disease stage of PD exhibiting postural instability will be recruited. The participants will
        receive 1-week training and be assessed at 3 time points: 1-week before, before, and after
        the training.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change from baseline postural sway at week 3
  time frame: Week 1 (2 assessments), Week 3 (1assessment)
  description: The midpoint between the tip of left and right calcaneus bones is considered as the origin of the reference system of the center of pressure (CoP). The CoP displacement along lateral and anterior-posterior axes are measured. The overall size of postural sways will be estimated from the ellipse area conveying 85% of the total CoP samples. The postural sway obtained from 2 assessments during week 1 will be averaged and used as baseline value. The postural sway obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).
  measure: Feasibility of Segway training
  time frame: Week 3 (1 assessment)
  description: The attendance of training session for each participant will be used to assess the feasibility of the 1-week postural training. Adherence above 80% will indicate that the participants receive the training well.
  measure: Change from baseline gait spatiotemporal parameters at week 3
  time frame: Week 1 (2 assessments), Week 3 (1assessment)
  description: Spatiotemporal parameters will be used to characterized walking in dual task and single task conditions. One gait cycle will be defined as period from heel strike to the consecutive heel strike of the ipsilateral leg. The gait's spatiotemporal parameters obtained from 2 assessments during week 1 will be averaged and used as baseline value. The gait's spatiotemporal parameters obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).
  measure: Change from baseline EEG spectral ratio at week 3
  time frame: Week 1 (2 assessments), Week 3 (1assessment)
  description: The absolute powers in delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), and beta (13 - 30 Hz) frequency bands obtained using Fast Fourier Transform will be used to calculate the spectral ratio of the frequency bands. The spectral ratio is defined as ratio of the sum of absolute powers in the alpha and beta bands divided by the sum of the absolute power in the delta and theta frequency bands. The spectral ratio obtained from 2 assessments during week 1 will be averaged and used as baseline value. The spectral ratio obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).
  arm group label: PD - individuals with Parkinson Disease, either male or female
  arm group type: Experimental
  description: Individuals, aged 50-85, with a clinical diagnosis of idiopathic Parkinson Disease, either male or female, with moderate disease stage presenting balance alterations (Hoehn or Yahr stage III)
  intervention type: Behavioral
  intervention name: Sensory-Augmented Postural Training
  description: To examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control and to assess the effectiveness of postural training using Segway
  arm group label: PD - individuals with Parkinson Disease, either male or female
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Yasin Dhaher, Ph.D.
  role: Principal Investigator
  affiliation: University of Texas Southwestern Medical Center
  last name: Yu-Chen Chung, PT, Ph.D.
  phone: 214-648-8838
  email: yu-chen.chung@utsouthwestern.edu
  last name: Subaryani Soedirdjo, Ph.D.
  email: subaryani.soedirdjo@utsouthwestern.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas Southwestern Medical Center
  investigator full name: Yasin Dhaher
  investigator title: Professor of Medicine
  mesh term: Parkinson Disease