<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/NCT04415775</url>
  </required_header>
  <id_info>
    <org_study_id>B2020:043</org_study_id>
    <nct_id>NCT04415775</nct_id>
  </id_info>
  <brief_title>Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease.</brief_title>
  <acronym>CMAGDT</acronym>
  <official_title>Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weston Brain Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manitoba</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 present proposal will evaluate the neural underpinnings of (a) the decline of mobility&#xD;
      function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided&#xD;
      dual-task (DT) mobility training platform (complementary approach: exercise intervention).&#xD;
      Improved mobility functioning in PD, specifically balance, gait and cognition, directly&#xD;
      translates to improved community ambulation as well as increased physical activity and social&#xD;
      participation. These benefits are known to have a significant preventive and&#xD;
      disease-modifying impact that surpasses any currently available pharmacological&#xD;
      interventions. Outcomes of this research will provide new insights into brain plasticity&#xD;
      mechanisms and will accelerate further optimization and commercialization of multi-modal&#xD;
      mobility-cognitive training applications along with accompanying smart electronic monitoring&#xD;
      tools. With wider usage of this training platform, rehabilitation specialists will be able to&#xD;
      effectively scale services, while still monitoring quality and ensuring accountability. Thus,&#xD;
      the study is highly transformative.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present proposal will evaluate the neural underpinnings of (a) the decline of mobility&#xD;
      function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided&#xD;
      dual-task (DT) mobility training platform (complementary approach: exercise intervention).&#xD;
      Improved mobility functioning in PD, specifically balance, gait and cognition, directly&#xD;
      translates to improved community ambulation as well as increased physical activity and social&#xD;
      participation. These benefits are known to have a significant preventive and&#xD;
      disease-modifying impact that surpasses any currently available pharmacological&#xD;
      interventions. Outcomes of this research will provide new insights into brain plasticity&#xD;
      mechanisms and will accelerate further optimization and commercialization of multi-modal&#xD;
      mobility-cognitive training applications along with accompanying smart electronic monitoring&#xD;
      tools. With wider usage of this training platform, rehabilitation specialists will be able to&#xD;
      effectively scale services, while still monitoring quality and ensuring accountability. Thus,&#xD;
      the study is highly transformative.&#xD;
&#xD;
      The investigators propose a collaborative project between our research centers at the&#xD;
      University of Manitoba and the University of Toronto, to further understand the neural&#xD;
      underpinnings of cognition/gait impairment and the effects of DT training in PD.&#xD;
&#xD;
      Cutting-edge behavioural brain imaging methods will be used to identify functional brain&#xD;
      metabolic network re-organization and the molecular basis of gait/cognitive impairment. This&#xD;
      will be used to evaluate the neurophysiological underpinnings of the DT treadmill training&#xD;
      effect, which has repeatedly demonstrated to be clinically effective. The possibility of&#xD;
      detecting these changes and localizing the site(s) of brain plasticity will have important&#xD;
      implications at several levels. These biomarkers could be used as an indicator of disease&#xD;
      severity, outcome measures for neuroprotection studies and other treatment and lifestyle&#xD;
      strategies.&#xD;
&#xD;
      Objective 1: To characterize the abnormal brain metabolic pattern in PD patients during&#xD;
      DT-walking as compared to healthy age-matched controls.&#xD;
&#xD;
      Objective 2: The investigators will examine whether a 10-week treadmill walking program&#xD;
      combined with specific cognitive activities (i.e. true DT walking training known to improve&#xD;
      gait function and reduce falls) will &quot;normalize&quot; the brain abnormality (that is identified in&#xD;
      Aim 1), or whether it will activate a novel compensatory mechanism and therefore evidence to&#xD;
      isolate the region(s) of brain plasticity.&#xD;
&#xD;
      The hypothesis is that the DT gait-related abnormal brain metabolic pattern and abnormally&#xD;
      elevated amyloid deposition are inter-related and that these abnormal functional connectivity&#xD;
      patterns and structural changes are highly associated with gait, cognitive and DT walking&#xD;
      deficits in PD. It is also hypothesized that the DT treadmill-training program will result in&#xD;
      specific and significant changes in the DT gait-related abnormal brain metabolic pattern, in&#xD;
      the PD participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2021</start_date>
  <completion_date type="Anticipated">November 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</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>One experimental group and other control group receiving control intervention.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>NDWP scores</measure>
    <time_frame>10 weeks</time_frame>
    <description>NDWP scores on PET scans of participants will be analysed to identify gait impairment related imagining signatures during single and dual-task walking, and after intervention. They will also be compared to age-matched healthy controls using student t-test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Step Length Coefficient of Variability</measure>
    <time_frame>10 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">67</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Dual-task walking Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Gait Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Game based treadmill Program</intervention_name>
    <description>Participants will be expected to play several cognitive computer games while standing on a sponge pad (10-min warm-up and while walking on the treadmill at your self-selected comfortable speed. (Dual-task treadmill training). This would be done in intervals of 2-4 min with rest periods for a total time of 35 minutes Treadmill speed and the difficulty level of the cognitive games will progress depending on participant performance and comfort level.</description>
    <arm_group_label>Dual-task walking Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Gait Rehabilitation</intervention_name>
    <description>Participants will undergo a mixture of current gait training programs available for people with Parkinson's Disease. The protocol will be a Warm-up exercise consisting of rhythmical large movements (10 minutes), as well as video game practice while standing (i.e., single-task; 10 minutes). Treadmill walking in intervals of 2-4 minutes with rest periods. Walking over the ground while negotiating through obstacles. (10 minutes) The speed of the treadmill will be progressed gradually and as tolerated.</description>
    <arm_group_label>Conventional Gait Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: (PD Participants)&#xD;
&#xD;
          -  Diagnosed with idiopathic PD, defined by the UK Brain Bank criterion in disease stage&#xD;
             2 - 3 (classified by Hoehn and Yahr scale),&#xD;
&#xD;
          -  Montreal cognitive assessment (MoCA) scores to be 25 or higher&#xD;
&#xD;
          -  Age 55-70 years&#xD;
&#xD;
          -  Stable medications for Parkinson over the past 3 months&#xD;
&#xD;
          -  Able to walk at least 50m without any assistive device&#xD;
&#xD;
          -  Episode of FOG in the past 6 months&#xD;
&#xD;
        Exclusion Criteria: (PD Participants)&#xD;
&#xD;
          -  The presence of neurological conditions other than PD affecting cognitive abilities.&#xD;
&#xD;
          -  Any orthopedic impairment affecting gait and balance.&#xD;
&#xD;
          -  Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a&#xD;
             treadmill;&#xD;
&#xD;
          -  Abnormal MRI&#xD;
&#xD;
          -  General contraindications.&#xD;
&#xD;
        Inclusion Criteria: (Healthy Controls)&#xD;
&#xD;
          -  Age 55-70 years,&#xD;
&#xD;
          -  Independent community living,&#xD;
&#xD;
          -  Not receiving any home care or Physiotherapy,&#xD;
&#xD;
          -  Walking outdoors for exercise for at least 3 times per week,&#xD;
&#xD;
          -  No neurological conditions affecting mobility or affecting cognitive abilities,&#xD;
&#xD;
          -  Any orthopedic impairment affecting gait and balance.&#xD;
&#xD;
          -  Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a&#xD;
             treadmill.&#xD;
&#xD;
          -  Abnormal MRI and&#xD;
&#xD;
          -  General contraindications for PET and MRI including severe dyskinesia, diabetes,&#xD;
             cardiac pacemakers.&#xD;
&#xD;
        Exclusion Criteria (Healthy Controls):&#xD;
&#xD;
          -  Any orthopedic impairment affecting gait and balance.&#xD;
&#xD;
          -  Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a&#xD;
             treadmill.&#xD;
&#xD;
          -  Abnormal MRI&#xD;
&#xD;
          -  General contraindications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tony Szturm, PhD</last_name>
    <phone>(204)-787-4794</phone>
    <email>tony.szturm@umanitoba.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>College of Rehabilitation Sciences, University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0T6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Dr. Tony Szturm</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dual task walking</keyword>
  <keyword>Treadmill walking</keyword>
  <keyword>PET scans</keyword>
  <keyword>Parkinson Disease</keyword>
  <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>


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/NCT04415775
org study id: B2020:043
nct id: NCT04415775
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present proposal will evaluate the neural underpinnings of (a) the decline of mobility
      function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided
      dual-task (DT) mobility training platform (complementary approach: exercise intervention).
      Improved mobility functioning in PD, specifically balance, gait and cognition, directly
      translates to improved community ambulation as well as increased physical activity and social
      participation. These benefits are known to have a significant preventive and
      disease-modifying impact that surpasses any currently available pharmacological
      interventions. Outcomes of this research will provide new insights into brain plasticity
      mechanisms and will accelerate further optimization and commercialization of multi-modal
      mobility-cognitive training applications along with accompanying smart electronic monitoring
      tools. With wider usage of this training platform, rehabilitation specialists will be able to
      effectively scale services, while still monitoring quality and ensuring accountability. Thus,
      the study is highly transformative.
The present proposal will evaluate the neural underpinnings of (a) the decline of mobility
      function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided
      dual-task (DT) mobility training platform (complementary approach: exercise intervention).
      Improved mobility functioning in PD, specifically balance, gait and cognition, directly
      translates to improved community ambulation as well as increased physical activity and social
      participation. These benefits are known to have a significant preventive and
      disease-modifying impact that surpasses any currently available pharmacological
      interventions. Outcomes of this research will provide new insights into brain plasticity
      mechanisms and will accelerate further optimization and commercialization of multi-modal
      mobility-cognitive training applications along with accompanying smart electronic monitoring
      tools. With wider usage of this training platform, rehabilitation specialists will be able to
      effectively scale services, while still monitoring quality and ensuring accountability. Thus,
      the study is highly transformative.

      The investigators propose a collaborative project between our research centers at the
      University of Manitoba and the University of Toronto, to further understand the neural
      underpinnings of cognition/gait impairment and the effects of DT training in PD.

      Cutting-edge behavioural brain imaging methods will be used to identify functional brain
      metabolic network re-organization and the molecular basis of gait/cognitive impairment. This
      will be used to evaluate the neurophysiological underpinnings of the DT treadmill training
      effect, which has repeatedly demonstrated to be clinically effective. The possibility of
      detecting these changes and localizing the site(s) of brain plasticity will have important
      implications at several levels. These biomarkers could be used as an indicator of disease
      severity, outcome measures for neuroprotection studies and other treatment and lifestyle
      strategies.

      Objective 1: To characterize the abnormal brain metabolic pattern in PD patients during
      DT-walking as compared to healthy age-matched controls.

      Objective 2: The investigators will examine whether a 10-week treadmill walking program
      combined with specific cognitive activities (i.e. true DT walking training known to improve
      gait function and reduce falls) will "normalize" the brain abnormality (that is identified in
      Aim 1), or whether it will activate a novel compensatory mechanism and therefore evidence to
      isolate the region(s) of brain plasticity.

      The hypothesis is that the DT gait-related abnormal brain metabolic pattern and abnormally
      elevated amyloid deposition are inter-related and that these abnormal functional connectivity
      patterns and structural changes are highly associated with gait, cognitive and DT walking
      deficits in PD. It is also hypothesized that the DT treadmill-training program will result in
      specific and significant changes in the DT gait-related abnormal brain metabolic pattern, in
      the PD participants.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One experimental group and other control group receiving control intervention.
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: NDWP scores
time frame: 10 weeks
description: NDWP scores on PET scans of participants will be analysed to identify gait impairment related imagining signatures during single and dual-task walking, and after intervention. They will also be compared to age-matched healthy controls using student t-test.
measure: Step Length Coefficient of Variability
time frame: 10 weeks
arm group label: Dual-task walking Intervention
arm group type: Experimental
arm group label: Conventional Gait Rehabilitation
arm group type: Active Comparator
arm group label: Healthy Controls
arm group type: No Intervention
intervention type: Other
intervention name: Game based treadmill Program
description: Participants will be expected to play several cognitive computer games while standing on a sponge pad (10-min warm-up and while walking on the treadmill at your self-selected comfortable speed. (Dual-task treadmill training). This would be done in intervals of 2-4 min with rest periods for a total time of 35 minutes Treadmill speed and the difficulty level of the cognitive games will progress depending on participant performance and comfort level.
arm group label: Dual-task walking Intervention
intervention type: Other
intervention name: Conventional Gait Rehabilitation
description: Participants will undergo a mixture of current gait training programs available for people with Parkinson's Disease. The protocol will be a Warm-up exercise consisting of rhythmical large movements (10 minutes), as well as video game practice while standing (i.e., single-task; 10 minutes). Treadmill walking in intervals of 2-4 minutes with rest periods. Walking over the ground while negotiating through obstacles. (10 minutes) The speed of the treadmill will be progressed gradually and as tolerated.
arm group label: Conventional Gait Rehabilitation
criteria: 
gender: All
minimum age: 55 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tony Szturm, PhD
phone: (204)-787-4794
email: tony.szturm@umanitoba.ca
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Dr. Tony Szturm
investigator title: Professor
mesh term: Parkinson Disease