<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/NCT02236286</url>
  </required_header>
  <id_info>
    <org_study_id>8979</org_study_id>
    <nct_id>NCT02236286</nct_id>
  </id_info>
  <brief_title>Frontal Cortex and Gait Freezing in Parkinson's Disease: Rehabilitation Impact</brief_title>
  <official_title>Frontal Cortex and Gait Freezing in Parkinson's Disease: Rehabilitation Impact</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will relate our new quantification of Freezing of Gait (FoG) in Parkinson's&#xD;
      disease, using body worn inertial sensors (Aim I), with abnormalities in state-of-the-art,&#xD;
      resting state, functional brain connectivity (Aim II), and determine the number of subjects&#xD;
      needed for a future, randomized clinical trial to test the efficacy of our novel, Agility&#xD;
      Boot Camp (ABC) rehabilitation intervention for FoG (Aim III). The technological approaches&#xD;
      to these aims are cutting edge and will allow us to develop sensitive behavioral and brain&#xD;
      biomarkers for gait disorders in Parkinson's disease (PD) for use in future clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Freezing of Gait Index</measure>
    <time_frame>Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)</time_frame>
    <description>Quantify amount of freezing in the legs ('trembling of knees'), defined as the square of the total power in the 3-8 Hz band, divided by the square of the total power in the 0.5-3 Hz band.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the New Freezing of Gait Questionnaire (NFOGQ) score</measure>
    <time_frame>Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)</time_frame>
    <description>The NFOGQ will be used to identify 'freezers' (score &gt; 3). It is a self-report measure that begins with the presentation of a short video to illustrate FoG during walking, turning and starting gait and then follows with questions related to frequency and duration of each type of FoG episode.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PDQ-39 score</measure>
    <time_frame>Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)</time_frame>
    <description>The Parkinson's Disease Quality of Life Questionnaire (PDQ-39) has 39 questions reflecting eight domains of quality of life (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort). Each item scores from 0 (never) to 4 (always). Subscale scores and a summary index representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life. Convergent validity is very good and discriminative validity for PD severity levels have been established. The PDQ-39 will reflect limitations to participation in community mobility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Activities of Balance Confidence (ABC) Questionnaire score</measure>
    <time_frame>Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)</time_frame>
    <description>ABC questionnaire consists of 16 questions about how balance confidence limits participating in the community such as riding an escalator or walking in a crowded area, Subjects indicate their confidence from 0 - 100% in being able to complete each of the tasks. A score of 80% indicates an average level of physical functioning for older adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in instrumented gait and balance measures</measure>
    <time_frame>Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)</time_frame>
    <description>Gait: Walking metrics will be collected during short (7 meter, 180° turn, 7 meter) and long (2 minutes) walks.&#xD;
Instrumented Brief BESTest - another variation of the BESTest (Balance Evaluation - Systems Test) that will be administered with inertial sensors to quantify the important metrics of the test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mini-BESTest score</measure>
    <time_frame>Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)</time_frame>
    <description>The mini-BESTest assesses dynamic balance via a 14-item test that measure multiple domains of balance including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in UPDRS score</measure>
    <time_frame>Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)</time_frame>
    <description>The Unified Parkinson's Disease Rating Scale (UPDRS) Motor Subscale is a 10-minute assessment of motor signs related to severity of PD. If the investigators have trouble recruiting subjects of similar severity in the 2 groups (PD Freezers and Non-Freezers, then they will use the Postural Instability and Gait Disability (PIGD) Subscore as a covariate in data analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in locomotor neural network functional connectivity strength</measure>
    <time_frame>Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)</time_frame>
    <description>Changes in resting state blood oxygen level dependent neural signal synchronization between Supplementary Motor Area and Mesencephalic locomotor region across 3 time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SCOPA-COG score</measure>
    <time_frame>Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)</time_frame>
    <description>Scales for Outcomes in Parkinson's Disease-cognition (SCOPA-COG) is an instrument that was designed to assess the specific 'frontal-subcortical' cognitive deficits found in Parkinson's disease. The scale, consisting of 10 items, covers the following domains: memory and recall (verbal recall, digit span backward, and indicate cubes), attention (counting backward, months backward), executive function (fist-edge-palm, semantic fluency, and dice), visual-spatial functions (assembly pattern), and memory (delayed recall). The score ranges from 0-43 points with higher scores reflecting better performance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will participate in a 90-minute, group (6 per group) exercise session 3 days per week for 6 weeks (18 sessions). The theoretical basis for our novel Agility Boot Camp (ABC) exercise program is based on research that identified the primary neurophysiological and cognitive constraints that limits balance and mobility in PD. The exercises are designed as a circuit with several types of movement-skills specifically focused on improving different postural domains with cognitive challenges such as memorized sequences and dual tasking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Disease Management Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will also receive (cross-over) six weeks of educational classes. The Education program will teach subjects, chronic disease self-management - how to live better with their parkinsonism. Classes will consist of 6 subjects per group meeting for 90 minute sessions, once a week for six weeks. Subject will do an additional 120 minutes of relaxation at home/week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.</description>
    <arm_group_label>Chronic Disease Management Education</arm_group_label>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 50-90 years old.&#xD;
&#xD;
          -  No musculoskeletal or peripheral or central nervous system disorders (other than&#xD;
             idiopathic Parkinson disease, iPD) that could significantly affect balance or gait .&#xD;
&#xD;
          -  Capable of following directions.&#xD;
&#xD;
          -  iPD subjects: United Kingdom Brain Bank criteria, i.e., bradykinesia and at least one&#xD;
             of the following: rest tremor, muscular rigidity, and postural instability not cause&#xD;
             by visual, vestibular, cerebellar or proprioceptive dysfunction. Unilateral onset,&#xD;
             response to levodopa.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to stand or walk for 2 min without an assistive device&#xD;
&#xD;
          -  Recent changes in medication&#xD;
&#xD;
          -  Excessive use of alcohol or recreational drugs,&#xD;
&#xD;
          -  Contraindications to MRI scans (eg, claustrophobia, metal in body)&#xD;
&#xD;
          -  Intervention subjects will be excluded if: 1) participating in a vigorous exercise&#xD;
             program more than 2 x/week, 2) A medical condition that contraindicates exercise&#xD;
             participation.&#xD;
&#xD;
          -  Idiopathic PD subjects: Same as above and deep brain stimulation electrodes.&#xD;
             Significant tremor that would interfere with MRI scan.&#xD;
&#xD;
        Control subjects:&#xD;
&#xD;
          -  Will be matched for age and gender to iPD group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fay B Horak, PhD, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Portland Health Care System (VAPORHCS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Portland Health Care System (VAPORHCS)</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>October 29, 2018</last_update_submitted>
  <last_update_submitted_qc>October 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Fay B. Horak</investigator_full_name>
    <investigator_title>Professor of Neurology</investigator_title>
  </responsible_party>
  <keyword>freezing of gait (FOG)</keyword>
  <keyword>balance</keyword>
  <keyword>gait</keyword>
  <keyword>exercise</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>


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/NCT02236286
org study id: 8979
nct id: NCT02236286
lead sponsor: 
collaborator: 
has dmc: No
This project will relate our new quantification of Freezing of Gait (FoG) in Parkinson's
      disease, using body worn inertial sensors (Aim I), with abnormalities in state-of-the-art,
      resting state, functional brain connectivity (Aim II), and determine the number of subjects
      needed for a future, randomized clinical trial to test the efficacy of our novel, Agility
      Boot Camp (ABC) rehabilitation intervention for FoG (Aim III). The technological approaches
      to these aims are cutting edge and will allow us to develop sensitive behavioral and brain
      biomarkers for gait disorders in Parkinson's disease (PD) for use in future clinical trials.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change in Freezing of Gait Index
time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
description: Quantify amount of freezing in the legs ('trembling of knees'), defined as the square of the total power in the 3-8 Hz band, divided by the square of the total power in the 0.5-3 Hz band.
measure: Change in the New Freezing of Gait Questionnaire (NFOGQ) score
time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
description: The NFOGQ will be used to identify 'freezers' (score > 3). It is a self-report measure that begins with the presentation of a short video to illustrate FoG during walking, turning and starting gait and then follows with questions related to frequency and duration of each type of FoG episode.
measure: Change in PDQ-39 score
time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
description: The Parkinson's Disease Quality of Life Questionnaire (PDQ-39) has 39 questions reflecting eight domains of quality of life (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort). Each item scores from 0 (never) to 4 (always). Subscale scores and a summary index representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life. Convergent validity is very good and discriminative validity for PD severity levels have been established. The PDQ-39 will reflect limitations to participation in community mobility.
measure: Change in Activities of Balance Confidence (ABC) Questionnaire score
time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
description: ABC questionnaire consists of 16 questions about how balance confidence limits participating in the community such as riding an escalator or walking in a crowded area, Subjects indicate their confidence from 0 - 100% in being able to complete each of the tasks. A score of 80% indicates an average level of physical functioning for older adults.
measure: Change in instrumented gait and balance measures
time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
description: Gait: Walking metrics will be collected during short (7 meter, 180° turn, 7 meter) and long (2 minutes) walks.
Instrumented Brief BESTest - another variation of the BESTest (Balance Evaluation - Systems Test) that will be administered with inertial sensors to quantify the important metrics of the test.
measure: Change in mini-BESTest score
time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
description: The mini-BESTest assesses dynamic balance via a 14-item test that measure multiple domains of balance including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.
measure: Change in UPDRS score
time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
description: The Unified Parkinson's Disease Rating Scale (UPDRS) Motor Subscale is a 10-minute assessment of motor signs related to severity of PD. If the investigators have trouble recruiting subjects of similar severity in the 2 groups (PD Freezers and Non-Freezers, then they will use the Postural Instability and Gait Disability (PIGD) Subscore as a covariate in data analysis.
measure: Change in locomotor neural network functional connectivity strength
time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
description: Changes in resting state blood oxygen level dependent neural signal synchronization between Supplementary Motor Area and Mesencephalic locomotor region across 3 time points.
measure: Change in SCOPA-COG score
time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
description: Scales for Outcomes in Parkinson's Disease-cognition (SCOPA-COG) is an instrument that was designed to assess the specific 'frontal-subcortical' cognitive deficits found in Parkinson's disease. The scale, consisting of 10 items, covers the following domains: memory and recall (verbal recall, digit span backward, and indicate cubes), attention (counting backward, months backward), executive function (fist-edge-palm, semantic fluency, and dice), visual-spatial functions (assembly pattern), and memory (delayed recall). The score ranges from 0-43 points with higher scores reflecting better performance.
arm group label: Exercise
arm group type: Experimental
description: Subjects will participate in a 90-minute, group (6 per group) exercise session 3 days per week for 6 weeks (18 sessions). The theoretical basis for our novel Agility Boot Camp (ABC) exercise program is based on research that identified the primary neurophysiological and cognitive constraints that limits balance and mobility in PD. The exercises are designed as a circuit with several types of movement-skills specifically focused on improving different postural domains with cognitive challenges such as memorized sequences and dual tasking.
arm group label: Chronic Disease Management Education
arm group type: Active Comparator
description: Subjects will also receive (cross-over) six weeks of educational classes. The Education program will teach subjects, chronic disease self-management - how to live better with their parkinsonism. Classes will consist of 6 subjects per group meeting for 90 minute sessions, once a week for six weeks. Subject will do an additional 120 minutes of relaxation at home/week.
intervention type: Behavioral
intervention name: Exercise
description: Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.
arm group label: Chronic Disease Management Education
arm group label: Exercise
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fay B Horak, PhD, PT
role: Principal Investigator
affiliation: VA Portland Health Care System (VAPORHCS)
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Fay B. Horak
investigator title: Professor of Neurology
mesh term: Parkinson Disease
sharing ipd: No