<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/NCT03298503</url>
  </required_header>
  <id_info>
    <org_study_id>201701080RINB</org_study_id>
    <nct_id>NCT03298503</nct_id>
  </id_info>
  <brief_title>Task-priority Effects on Postural-suprapostural Task in Patients With Parkinson's Disease</brief_title>
  <official_title>Effects of Task Prioritization on Postural-suprapostural Task and Brain Activity in Parkinson's Disease With Different Balance Ability: During Standing and Walking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Postural-suprapostural task is defined as postural control takes place while at least one&#xD;
      other concurrent task is being performed. In a postural-suprapostural task, appropriate&#xD;
      prioritization of is necessary to achieve task goals and maintain postural stability.&#xD;
      Therefore, regarding to impose task prioritization in a postural-suprapostural task, the&#xD;
      optimal task-priority strategy for PD patients is still an issue of debate. With the uses of&#xD;
      EEG, EMG and behavioral measures, the purpose of this project is to investigate the&#xD;
      differences in performance quality and intrinsic neural mechanisms of a&#xD;
      postural-suprapostural task for PD patients, by adopting posture-focus and&#xD;
      suprapostural-focus strategies during standing and walking. The present project is expected&#xD;
      to have significant contributions not only to gain a better insight to neural correlates of&#xD;
      concurrent postural and suprapostural tasks with different task prioritization under standing&#xD;
      and walking, but to optimize treatment strategy for PD patients with balance or dual-tasking&#xD;
      disturbances.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postural-suprapostural task is defined as postural control takes place while at least one&#xD;
      other concurrent task is being performed. In a postural-suprapostural task, appropriate&#xD;
      prioritization of is necessary to achieve task goals and maintain postural stability. Some&#xD;
      studies support that a &quot;posture-first&quot; strategy is favored by patients with Parkinson disease&#xD;
      (PD) in order to secure stance stability, but this comes at the cost of reduced suprapostural&#xD;
      performance. In addition, overemphasizing on postural task might deteriorate automatic&#xD;
      control of posture resulting in increased postural instability, and the best task-priority&#xD;
      strategy might vary with balance ability of PD patients. Therefore, regarding to impose task&#xD;
      prioritization in a postural-suprapostural task, the optimal task-priority strategy for PD&#xD;
      patients is still an issue of debate. With the uses of EEG, EMG and behavioral measures, the&#xD;
      purpose of this 2-year research project is to investigate the differences in performance&#xD;
      quality and intrinsic neural mechanisms of a postural-suprapostural task for PD patients, by&#xD;
      adopting posture-focus and suprapostural-focus strategies during standing and walking. In the&#xD;
      first year, we will characterize task prioritization effect on reciprocity of a&#xD;
      postural-suprapostural task, with a special focus on modulation of brain and muscle activity&#xD;
      patterns in standing posture for early stage (modified H &amp; Y: 1, 1.5 and 2) and moderate&#xD;
      stage (modified H &amp; Y: 2.5 and 3) PD patients. In the second year, the appropriate task&#xD;
      prioritization, walking automaticity and power/connectivity of brain areas will be&#xD;
      investigated in walking for PD patients with/without freezing of gait. The present project is&#xD;
      expected to have significant contributions not only to gain a better insight to neural&#xD;
      correlates of concurrent postural and suprapostural tasks with different task prioritization&#xD;
      under standing and walking, but to optimize treatment strategy for PD patients with balance&#xD;
      or dual-tasking disturbances.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 5, 2017</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Actual">December 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electroencephalography (EEG)</measure>
    <time_frame>about 30 seconds for each trial, total about 30 minutes</time_frame>
    <description>to collect the brain activity (unit: uV)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electromyography (EMG)</measure>
    <time_frame>about 30 seconds for each trial, total about 30 minutes</time_frame>
    <description>to collect the muscle activity (unit: mV)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gait parameters (GAITRite)</measure>
    <time_frame>about 30 seconds for each trial, total about 30 minutes</time_frame>
    <description>to know how the subjects walk during the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center of pressure (COP)</measure>
    <time_frame>about 30 seconds for each trial, total about 30 minutes</time_frame>
    <description>to know how the subjects stand during the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tilting angle of inclinometer</measure>
    <time_frame>about 30 seconds for each trial, total about 30 minutes</time_frame>
    <description>to know how the subjects perform the suprapostural task during the trial</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>early stage or non-freezers PD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>early stage defined as modified Hoehn and Yahr scale 1, 1.5 and 2, means that symptoms involved unilateral or bilateral without impairment of balance.&#xD;
non-freezers defined as without freezing of gait, means that patients without transient inability to generate effective stepping.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>moderate stage or freezers PD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>moderate stage defined as modified Hoehn and Yahr scale 2.5 and 3, means that symptoms involved unilateral or bilateral without impairment of balance.&#xD;
freezers defined as with freezing of gait, means that patients have transient inability to generate effective stepping.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>task-priority strategies</intervention_name>
    <description>posture-focus strategy: when performing postural-suprapostural task (dual-task), the patient mainly focus on postural task (standing/walking).&#xD;
supraposture-focus strategy: when performing postural-suprapostural task (dual-task), the patient mainly focus on suprapostural task (stabilize the tray).</description>
    <arm_group_label>early stage or non-freezers PD</arm_group_label>
    <arm_group_label>moderate stage or freezers PD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        inclusion criteria:&#xD;
&#xD;
          1. patients with Parkinson's Disease in H&amp;Y stage from stage 1 to stage 3&#xD;
&#xD;
          2. without other neurological disease with balance impairment&#xD;
&#xD;
          3. can stand and walk without aids for at least 30 seconds&#xD;
&#xD;
        exclusion criteria:&#xD;
&#xD;
          1. Mini-Mental State Examination &gt; 27&#xD;
&#xD;
          2. Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale&#xD;
             (QUIP-RS) &lt; 10&#xD;
&#xD;
          3. Hamilton Depression Rating Scale (HAM-D) &lt; 17&#xD;
&#xD;
          4. pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheng-Ya Huang, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>School &amp; Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cheng-Ya Huang, Ph.D.</last_name>
    <phone>+886-3366-8131</phone>
    <email>rcyhuang@ntu.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fu-Chang Tsai, Ph.D.</last_name>
    <phone>+886-2312-3456</phone>
    <phone_ext>88576</phone_ext>
    <email>fctsai@ntu.edu.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheng-Ya Huang, Ph.D.</last_name>
      <phone>+886-3366-8131</phone>
      <email>rcyhuang@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Peterson DS, Fling BW, Mancini M, Cohen RG, Nutt JG, Horak FB. Dual-task interference and brain structural connectivity in people with Parkinson's disease who freeze. J Neurol Neurosurg Psychiatry. 2015 Jul;86(7):786-92. doi: 10.1136/jnnp-2014-308840. Epub 2014 Sep 15.</citation>
    <PMID>25224677</PMID>
  </reference>
  <reference>
    <citation>Kelly VE, Eusterbrock AJ, Shumway-Cook A. A review of dual-task walking deficits in people with Parkinson's disease: motor and cognitive contributions, mechanisms, and clinical implications. Parkinsons Dis. 2012;2012:918719. doi: 10.1155/2012/918719. Epub 2011 Oct 27.</citation>
    <PMID>22135764</PMID>
  </reference>
  <reference>
    <citation>Shumway-Cook A, Woollacott M, Kerns KA, Baldwin M. The effects of two types of cognitive tasks on postural stability in older adults with and without a history of falls. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M232-40. doi: 10.1093/gerona/52a.4.m232.</citation>
    <PMID>9224435</PMID>
  </reference>
  <reference>
    <citation>Beck EN, Ehgoetz Martens KA, Almeida QJ. Freezing of Gait in Parkinson's Disease: An Overload Problem? PLoS One. 2015 Dec 17;10(12):e0144986. doi: 10.1371/journal.pone.0144986. eCollection 2015.</citation>
    <PMID>26678262</PMID>
  </reference>
  <reference>
    <citation>Mitra S, Fraizer EV. Effects of explicit sway-minimization on postural--suprapostural dual-task performance. Hum Mov Sci. 2004 Jun;23(1):1-20. doi: 10.1016/j.humov.2004.03.003.</citation>
    <PMID>15201038</PMID>
  </reference>
  <reference>
    <citation>Vervoort G, Heremans E, Bengevoord A, Strouwen C, Nackaerts E, Vandenberghe W, Nieuwboer A. Dual-task-related neural connectivity changes in patients with Parkinson' disease. Neuroscience. 2016 Mar 11;317:36-46. doi: 10.1016/j.neuroscience.2015.12.056. Epub 2016 Jan 5.</citation>
    <PMID>26762801</PMID>
  </reference>
  <reference>
    <citation>Knaepen K, Mierau A, Tellez HF, Lefeber D, Meeusen R. Temporal and spatial organization of gait-related electrocortical potentials. Neurosci Lett. 2015 Jul 10;599:75-80. doi: 10.1016/j.neulet.2015.05.036. Epub 2015 May 21.</citation>
    <PMID>26003448</PMID>
  </reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>May 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2017</last_update_submitted>
  <last_update_submitted_qc>December 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>posture balance</keyword>
  <keyword>attention</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/NCT03298503
org study id: 201701080RINB
nct id: NCT03298503
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postural-suprapostural task is defined as postural control takes place while at least one
      other concurrent task is being performed. In a postural-suprapostural task, appropriate
      prioritization of is necessary to achieve task goals and maintain postural stability.
      Therefore, regarding to impose task prioritization in a postural-suprapostural task, the
      optimal task-priority strategy for PD patients is still an issue of debate. With the uses of
      EEG, EMG and behavioral measures, the purpose of this project is to investigate the
      differences in performance quality and intrinsic neural mechanisms of a
      postural-suprapostural task for PD patients, by adopting posture-focus and
      suprapostural-focus strategies during standing and walking. The present project is expected
      to have significant contributions not only to gain a better insight to neural correlates of
      concurrent postural and suprapostural tasks with different task prioritization under standing
      and walking, but to optimize treatment strategy for PD patients with balance or dual-tasking
      disturbances.
Postural-suprapostural task is defined as postural control takes place while at least one
      other concurrent task is being performed. In a postural-suprapostural task, appropriate
      prioritization of is necessary to achieve task goals and maintain postural stability. Some
      studies support that a "posture-first" strategy is favored by patients with Parkinson disease
      (PD) in order to secure stance stability, but this comes at the cost of reduced suprapostural
      performance. In addition, overemphasizing on postural task might deteriorate automatic
      control of posture resulting in increased postural instability, and the best task-priority
      strategy might vary with balance ability of PD patients. Therefore, regarding to impose task
      prioritization in a postural-suprapostural task, the optimal task-priority strategy for PD
      patients is still an issue of debate. With the uses of EEG, EMG and behavioral measures, the
      purpose of this 2-year research project is to investigate the differences in performance
      quality and intrinsic neural mechanisms of a postural-suprapostural task for PD patients, by
      adopting posture-focus and suprapostural-focus strategies during standing and walking. In the
      first year, we will characterize task prioritization effect on reciprocity of a
      postural-suprapostural task, with a special focus on modulation of brain and muscle activity
      patterns in standing posture for early stage (modified H & Y: 1, 1.5 and 2) and moderate
      stage (modified H & Y: 2.5 and 3) PD patients. In the second year, the appropriate task
      prioritization, walking automaticity and power/connectivity of brain areas will be
      investigated in walking for PD patients with/without freezing of gait. The present project is
      expected to have significant contributions not only to gain a better insight to neural
      correlates of concurrent postural and suprapostural tasks with different task prioritization
      under standing and walking, but to optimize treatment strategy for PD patients with balance
      or dual-tasking disturbances.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Electroencephalography (EEG)
time frame: about 30 seconds for each trial, total about 30 minutes
description: to collect the brain activity (unit: uV)
measure: Electromyography (EMG)
time frame: about 30 seconds for each trial, total about 30 minutes
description: to collect the muscle activity (unit: mV)
measure: Gait parameters (GAITRite)
time frame: about 30 seconds for each trial, total about 30 minutes
description: to know how the subjects walk during the trial
measure: Center of pressure (COP)
time frame: about 30 seconds for each trial, total about 30 minutes
description: to know how the subjects stand during the trial
measure: Tilting angle of inclinometer
time frame: about 30 seconds for each trial, total about 30 minutes
description: to know how the subjects perform the suprapostural task during the trial
arm group label: early stage or non-freezers PD
arm group type: Active Comparator
description: early stage defined as modified Hoehn and Yahr scale 1, 1.5 and 2, means that symptoms involved unilateral or bilateral without impairment of balance.
non-freezers defined as without freezing of gait, means that patients without transient inability to generate effective stepping.
arm group label: moderate stage or freezers PD
arm group type: Experimental
description: moderate stage defined as modified Hoehn and Yahr scale 2.5 and 3, means that symptoms involved unilateral or bilateral without impairment of balance.
freezers defined as with freezing of gait, means that patients have transient inability to generate effective stepping.
intervention type: Other
intervention name: task-priority strategies
description: posture-focus strategy: when performing postural-suprapostural task (dual-task), the patient mainly focus on postural task (standing/walking).
supraposture-focus strategy: when performing postural-suprapostural task (dual-task), the patient mainly focus on suprapostural task (stabilize the tray).
arm group label: early stage or non-freezers PD
arm group label: moderate stage or freezers PD
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Cheng-Ya Huang, Ph.D.
role: Principal Investigator
affiliation: School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
last name: Cheng-Ya Huang, Ph.D.
phone: +886-3366-8131
email: rcyhuang@ntu.edu.tw
last name: Fu-Chang Tsai, Ph.D.
phone: +886-2312-3456
phone ext: 88576
email: fctsai@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: Peterson DS, Fling BW, Mancini M, Cohen RG, Nutt JG, Horak FB. Dual-task interference and brain structural connectivity in people with Parkinson's disease who freeze. J Neurol Neurosurg Psychiatry. 2015 Jul;86(7):786-92. doi: 10.1136/jnnp-2014-308840. Epub 2014 Sep 15.
PMID: 25224677
citation: Kelly VE, Eusterbrock AJ, Shumway-Cook A. A review of dual-task walking deficits in people with Parkinson's disease: motor and cognitive contributions, mechanisms, and clinical implications. Parkinsons Dis. 2012;2012:918719. doi: 10.1155/2012/918719. Epub 2011 Oct 27.
PMID: 22135764
citation: Shumway-Cook A, Woollacott M, Kerns KA, Baldwin M. The effects of two types of cognitive tasks on postural stability in older adults with and without a history of falls. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M232-40. doi: 10.1093/gerona/52a.4.m232.
PMID: 9224435
citation: Beck EN, Ehgoetz Martens KA, Almeida QJ. Freezing of Gait in Parkinson's Disease: An Overload Problem? PLoS One. 2015 Dec 17;10(12):e0144986. doi: 10.1371/journal.pone.0144986. eCollection 2015.
PMID: 26678262
citation: Mitra S, Fraizer EV. Effects of explicit sway-minimization on postural--suprapostural dual-task performance. Hum Mov Sci. 2004 Jun;23(1):1-20. doi: 10.1016/j.humov.2004.03.003.
PMID: 15201038
citation: Vervoort G, Heremans E, Bengevoord A, Strouwen C, Nackaerts E, Vandenberghe W, Nieuwboer A. Dual-task-related neural connectivity changes in patients with Parkinson' disease. Neuroscience. 2016 Mar 11;317:36-46. doi: 10.1016/j.neuroscience.2015.12.056. Epub 2016 Jan 5.
PMID: 26762801
citation: Knaepen K, Mierau A, Tellez HF, Lefeber D, Meeusen R. Temporal and spatial organization of gait-related electrocortical potentials. Neurosci Lett. 2015 Jul 10;599:75-80. doi: 10.1016/j.neulet.2015.05.036. Epub 2015 May 21.
PMID: 26003448
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No