<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/NCT03835611</url>
  </required_header>
  <id_info>
    <org_study_id>H2018:338</org_study_id>
    <nct_id>NCT03835611</nct_id>
  </id_info>
  <brief_title>Evaluating Effect of Cognitive Game Based Treadmill Exercise Program in Parkinson Disease</brief_title>
  <official_title>Evaluating the Use of a Cognitive Game-Based Treadmill Exercise Program to Improve Balance and Gait in People With Parkinson Disease: A Feasibility Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      An inexpensive dual-task gait training protocol has been developed for people with PD namely&#xD;
      game based treadmill platform. A feasibility randomized trial clinical trail will be&#xD;
      conducted to evaluate the feasibility, acceptability and estimate treatment effect size of&#xD;
      the treatment protocol to conduct a future RCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson's disease (PD) is the second most commonly occurring neurological disorder in&#xD;
      Canada, affecting approximately 99,000 individuals, and the number is expected to grow to&#xD;
      140,000 individuals by the year 2025. The hallmark of PD pathology is a progressive&#xD;
      degeneration of dopaminergic neurons in the basal ganglia (BG). Therefore, there is a&#xD;
      significant deterioration of balance and gait function, and especially when concurrently&#xD;
      performing a cognitive task (dual-task walking). Fifty percent of individuals with PD also&#xD;
      show deficiencies in one or more cognitive area. In addition, up to 80% of PD patients&#xD;
      eventually develop dementia. Over 60% of PD, individuals fall each year and a significant&#xD;
      portion of those who fall will experience multiple falls. Most falls occur during walking,&#xD;
      and the consequences of these falls are often severe, leading to disability, loss of&#xD;
      independence (i.e. safe community ambulation). For individuals with PD, community ambulation&#xD;
      is strongly associated with the preservation of skills for independent living,&#xD;
      leisure/recreational activities, social participation and healthy aging. Daily activities&#xD;
      afford numerous situations in which walking must be combined with a cognitive task, such as,&#xD;
      navigation, negotiating terrains and obstacles, tracking visual targets, reading, and recall.&#xD;
      Walking and cognitive abilities are closely linked, and several studies have demonstrated&#xD;
      that walking while performing various cognitive tasks (dual-task walking) results in greater&#xD;
      gait disturbances, threats to stability and provokes freezing of gait in PD.&#xD;
&#xD;
      Numerous studies have shown that modest levels of physical activity and targeted physical&#xD;
      therapy improves muscle strength, balance, mobility and reduces the risk of falls among older&#xD;
      adults. Several studies have also shown improved cognitive function with physical activity,&#xD;
      and others report that interventions that enhance cognitive skills led to improvements in&#xD;
      fall risk. Because physical and executive cognitive decline both contribute to mobility&#xD;
      limitations and an increased fall risk with age, several PD researchers and clinicians have&#xD;
      developed balance-walking programs augmented with interactive cognitive activities (Dual-task&#xD;
      training). Maximizing participation is also seen as a main goal of interventions. Long-term&#xD;
      exercise/training programs are often fraught with low compliance and adherence. An emerging&#xD;
      methodology is to combine exercise and activities with computer games, making the training&#xD;
      experience more engaging and enjoyable. This approach can be an important tool for&#xD;
      rehabilitation because it has the potential to increase participation and exercise adherence.&#xD;
      Importantly digital media in the form of computer games can also challenge and train many&#xD;
      different aspects of executive cognitive function. For example, many computer games are now&#xD;
      readily available in which processing speed, cognitive inhibition, task switching, working&#xD;
      memory and problem solving are the main components of the interactive game events.&#xD;
&#xD;
      Based on this information, investigators have has developed and validated an engaging,&#xD;
      game-based treadmill platform (GTP), which provides an integrated approach to treat and&#xD;
      assess the decline in balance, mobility, Visuomotor and visuospatial executive cognitive&#xD;
      function. The GTP consists of 1) a standard treadmill instrumented with a pressure mapping&#xD;
      system which to compute several spatiotemporal gait variables and gait stability measures; 2)&#xD;
      an innovative interactive computer game subsystem for dual-tasking; and 3) an automated&#xD;
      monitoring application which uses advanced data logging and analysis method to record the&#xD;
      client's actions and choices while walking and playing targeted cognitive games. Therefore,&#xD;
      physical and cognitive performance during exercise can be monitored synchronously and&#xD;
      quantified electronically. Proof of principle has been established for the use of the GTP in&#xD;
      assessment and treatment of older adult's age70-80 with fall history.&#xD;
&#xD;
      Purpose of this exploratory study is to assess the potential for successful implementation of&#xD;
      the novel intervention, predict the feasibility and acceptability of the dual-task exercise&#xD;
      program and identify unpredicted harm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of Recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention to GTP</measure>
    <time_frame>1 year</time_frame>
    <description>Percentage of participants adhering to 10 Weeks of GTP protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sample size calculation</measure>
    <time_frame>1 Year</time_frame>
    <description>Power calculation will be done with coefficient of variation of step length during DT walking as primary outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention Group: Participants in the intervention group will receive DT TT with GTP. GTP consists of standard treadmill nested with a pressure mapping system and an interactive computer game based sub-station in front of the treadmill. A miniature motion mouse with inbuilt sensors that enables &quot;real-time&quot; movements to be translated in computer sub-station by standard USB will be used. This miniature mouse will be secured to a helmet that participants will wear while walking on the treadmill to interact with computer sub-station. Participants will be expected to play commercial computer games while standing on compliant surface or walking on the treadmill. The motion mouse will help participants to control computer games hand free.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group: Participants in the control group will undergo a mixture of current gait training programs available for people with Parkinson Disease. The protocol will be:</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Game based treadmill Platform</intervention_name>
    <description>The protocol for the intervention group will be:&#xD;
Warm up exercised consisting of rhythmical large movements (10minutes)&#xD;
Dynamic standing balance training by playing commercial games with head rotations while standing on a compliant surface to increase balance demands. (10 Minutes)&#xD;
DT treadmill training, consisting of playing commercial computer games while walking on the treadmill at a self-selected comfortable speed. Participants will be allowed to take rest when required and total effective DT treadmill walking will be for 30minutes. Treadmill speed will be aimed to progress depending on participant performance and documented. An overhead safety harness will always be provided to participants while walking on the treadmill. (25minutes)</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>Warm-up exercise consisting of rhythmical large movements (10 minutes).&#xD;
Core standing balance exercises on a sponge surface (10 minutes).&#xD;
Treadmill walking for 20 minutes, which includes rests periods... An overhead safety harness will be provided to participants while walking on the treadmill&#xD;
Overground walking in an obstacle course. Participants will be instructed to walk along a curved path (marked by tape) and avoid obstacles placed randomly. The obstacle will be thin sponge pads with 10-12 inches in diameter (15minutes).</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range 55-70&#xD;
&#xD;
          -  Diagnosed with PD according to UK brain bank criteria,&#xD;
&#xD;
          -  PD stage 1-3 on Hoehn and Yahr scale,&#xD;
&#xD;
          -  On stable medications for PD from past 3months,&#xD;
&#xD;
          -  Able to walk 50m independently,&#xD;
&#xD;
          -  Montreal Cognitive Assessment( MoCA) score of more than 21(Non-Dementia PD).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other neurodegenerative condition,&#xD;
&#xD;
          -  Any orthopedic or cardiovascular impairment limiting independent walking for a minimum&#xD;
             of 10 minutes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson Disease,</keyword>
  <keyword>Balance</keyword>
  <keyword>Gait</keyword>
  <keyword>Dual Task walking</keyword>
  <keyword>Feasibility</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>Undecided</sharing_ipd>
    <ipd_description>No discussion yet.</ipd_description>
  </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/NCT03835611
org study id: H2018:338
nct id: NCT03835611
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An inexpensive dual-task gait training protocol has been developed for people with PD namely
      game based treadmill platform. A feasibility randomized trial clinical trail will be
      conducted to evaluate the feasibility, acceptability and estimate treatment effect size of
      the treatment protocol to conduct a future RCT.
Parkinson's disease (PD) is the second most commonly occurring neurological disorder in
      Canada, affecting approximately 99,000 individuals, and the number is expected to grow to
      140,000 individuals by the year 2025. The hallmark of PD pathology is a progressive
      degeneration of dopaminergic neurons in the basal ganglia (BG). Therefore, there is a
      significant deterioration of balance and gait function, and especially when concurrently
      performing a cognitive task (dual-task walking). Fifty percent of individuals with PD also
      show deficiencies in one or more cognitive area. In addition, up to 80% of PD patients
      eventually develop dementia. Over 60% of PD, individuals fall each year and a significant
      portion of those who fall will experience multiple falls. Most falls occur during walking,
      and the consequences of these falls are often severe, leading to disability, loss of
      independence (i.e. safe community ambulation). For individuals with PD, community ambulation
      is strongly associated with the preservation of skills for independent living,
      leisure/recreational activities, social participation and healthy aging. Daily activities
      afford numerous situations in which walking must be combined with a cognitive task, such as,
      navigation, negotiating terrains and obstacles, tracking visual targets, reading, and recall.
      Walking and cognitive abilities are closely linked, and several studies have demonstrated
      that walking while performing various cognitive tasks (dual-task walking) results in greater
      gait disturbances, threats to stability and provokes freezing of gait in PD.

      Numerous studies have shown that modest levels of physical activity and targeted physical
      therapy improves muscle strength, balance, mobility and reduces the risk of falls among older
      adults. Several studies have also shown improved cognitive function with physical activity,
      and others report that interventions that enhance cognitive skills led to improvements in
      fall risk. Because physical and executive cognitive decline both contribute to mobility
      limitations and an increased fall risk with age, several PD researchers and clinicians have
      developed balance-walking programs augmented with interactive cognitive activities (Dual-task
      training). Maximizing participation is also seen as a main goal of interventions. Long-term
      exercise/training programs are often fraught with low compliance and adherence. An emerging
      methodology is to combine exercise and activities with computer games, making the training
      experience more engaging and enjoyable. This approach can be an important tool for
      rehabilitation because it has the potential to increase participation and exercise adherence.
      Importantly digital media in the form of computer games can also challenge and train many
      different aspects of executive cognitive function. For example, many computer games are now
      readily available in which processing speed, cognitive inhibition, task switching, working
      memory and problem solving are the main components of the interactive game events.

      Based on this information, investigators have has developed and validated an engaging,
      game-based treadmill platform (GTP), which provides an integrated approach to treat and
      assess the decline in balance, mobility, Visuomotor and visuospatial executive cognitive
      function. The GTP consists of 1) a standard treadmill instrumented with a pressure mapping
      system which to compute several spatiotemporal gait variables and gait stability measures; 2)
      an innovative interactive computer game subsystem for dual-tasking; and 3) an automated
      monitoring application which uses advanced data logging and analysis method to record the
      client's actions and choices while walking and playing targeted cognitive games. Therefore,
      physical and cognitive performance during exercise can be monitored synchronously and
      quantified electronically. Proof of principle has been established for the use of the GTP in
      assessment and treatment of older adult's age70-80 with fall history.

      Purpose of this exploratory study is to assess the potential for successful implementation of
      the novel intervention, predict the feasibility and acceptability of the dual-task exercise
      program and identify unpredicted harm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Retention to GTP
time frame: 1 year
description: Percentage of participants adhering to 10 Weeks of GTP protocol.
measure: Sample size calculation
time frame: 1 Year
description: Power calculation will be done with coefficient of variation of step length during DT walking as primary outcome measure.
arm group label: Intervention group
arm group type: Experimental
description: Intervention Group: Participants in the intervention group will receive DT TT with GTP. GTP consists of standard treadmill nested with a pressure mapping system and an interactive computer game based sub-station in front of the treadmill. A miniature motion mouse with inbuilt sensors that enables "real-time" movements to be translated in computer sub-station by standard USB will be used. This miniature mouse will be secured to a helmet that participants will wear while walking on the treadmill to interact with computer sub-station. Participants will be expected to play commercial computer games while standing on compliant surface or walking on the treadmill. The motion mouse will help participants to control computer games hand free.
arm group label: Control Group
arm group type: Active Comparator
description: Control group: Participants in the control group will undergo a mixture of current gait training programs available for people with Parkinson Disease. The protocol will be:
intervention type: Other
intervention name: Game based treadmill Platform
description: The protocol for the intervention group will be:
Warm up exercised consisting of rhythmical large movements (10minutes)
Dynamic standing balance training by playing commercial games with head rotations while standing on a compliant surface to increase balance demands. (10 Minutes)
DT treadmill training, consisting of playing commercial computer games while walking on the treadmill at a self-selected comfortable speed. Participants will be allowed to take rest when required and total effective DT treadmill walking will be for 30minutes. Treadmill speed will be aimed to progress depending on participant performance and documented. An overhead safety harness will always be provided to participants while walking on the treadmill. (25minutes)
arm group label: Intervention group
intervention type: Other
intervention name: Control Group
description: Warm-up exercise consisting of rhythmical large movements (10 minutes).
Core standing balance exercises on a sponge surface (10 minutes).
Treadmill walking for 20 minutes, which includes rests periods... An overhead safety harness will be provided to participants while walking on the treadmill
Overground walking in an obstacle course. Participants will be instructed to walk along a curved path (marked by tape) and avoid obstacles placed randomly. The obstacle will be thin sponge pads with 10-12 inches in diameter (15minutes).
arm group label: Control Group
criteria: 
gender: All
minimum age: 55 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Undecided
ipd description: No discussion yet.