<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/NCT04503187</url>
  </required_header>
  <id_info>
    <org_study_id>TWU Houston#17203</org_study_id>
    <nct_id>NCT04503187</nct_id>
  </id_info>
  <brief_title>Motor Skill Acquisition Between Individuals With Neurological Disorders and Healthy Individuals</brief_title>
  <official_title>Comparison of Motor Skill Acquisition Between Individuals With Neurological Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Woman's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Woman's University</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>
      Stroke survivors frequently show persistent gait deficits in their chronic stages even after&#xD;
      years of intensive rehabilitation. This may be caused by diminished capability of&#xD;
      re-acquiring motor skills post stroke. Thus, the overall purpose of this research project is&#xD;
      to examine stroke survivors' capability of learning a novel leg task over 3 visits, 1-2 weeks&#xD;
      apart. The capability of learning a new skill is then correlated with the individual's&#xD;
      neurological functions (nerve activity and movement coordination) and her/his gait&#xD;
      performance (gait speed, gait symmetry, and force production).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The walking after stroke called &quot;hemiparetic gait&quot; is characterized by slow and asymmetrical&#xD;
      steps with poor motor control on the paretic leg while paradoxically increasing the cost of&#xD;
      energy expenditure. Biomechanical evidence shows that impaired gait performance for people&#xD;
      with chronic stroke is not solely the result of the loss of muscle strength, but involves&#xD;
      complicated movement discoordination across multiple joints in the affected leg. This has&#xD;
      been taken to indicate a persistent motor control deficit in the paretic leg post stroke.&#xD;
      Recent imaging studies suggest that the persistent motor control deficit after stroke may be&#xD;
      the result of the disruption of motor memory consolidation, a process by which a&#xD;
      newly-learned motor skill is transformed from a fragile state to a stable state and is&#xD;
      &quot;saved&quot; in our brain afterward. This indicates that the same brain area responsible for&#xD;
      controlling motor activity is also involved in memorizing newly-learned skills during the&#xD;
      early stage of motor learning. Presence of persistent motor control deficits in the chronic&#xD;
      stage may be attributed to the fact that damage to the brain cortex significantly impacts the&#xD;
      ability of acquiring motor skills and consequentially defers the improvement of motor&#xD;
      function, including gait.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 4, 2013</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in movement errors</measure>
    <time_frame>During the first session of learning visuomotor leg reaching task, 24-hour after the first session, and 7-days after the first learning learning session</time_frame>
    <description>Average movement error will be calculated as the angular deviation of the foot path from a straight line path to the target at the time of peak velocity in each trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral nerve activity</measure>
    <time_frame>During the first session of learning visuomotor leg reaching task</time_frame>
    <description>A surface electrode will be placed on the calf muscle in one leg. Then a low-intensity of electrical stimulation will be delivered to a nerve behind the knee to trigger the motor responses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking performance</measure>
    <time_frame>Before the first session of learning visuomotor leg reaching task</time_frame>
    <description>Gait speed will be calculated during overground walking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-mental State Examination</measure>
    <time_frame>Before the first session of learning visuomotor leg reaching task</time_frame>
    <description>A standardized questionnaires to evaluate the cognitive function consisting of 11 items with a possible summed score ranging from zero to 30. The most widely accepted and frequently used cutoff score for the MMSE is 23, with scores of 23 or lower indicating the presence of cognitive impairment. A higher score means a better cognitive function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Lower Extremity Function Assessment</measure>
    <time_frame>Before the first session of learning visuomotor leg reaching task</time_frame>
    <description>A standardized questionnaires to evaluate the lower extremity motor function consisting of movement, coordination, and reflex assessments at hip, knee, and ankle. Possible summed scores range from zero to 34. Higher scores indicate higher and better motor function.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Stroke</condition>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Chronic Stroke</arm_group_label>
    <description>Participants who suffered a single event of cerebral vascular accident at least six months ago before study enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Sclerosis</arm_group_label>
    <description>Participants who has been diagnosed with multiple sclerosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <description>Age-matched healthy adults who are self-reported healthy and has no known musculoskeletal, neuromuscular, and cardiovascular diseases.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Visuomotor leg reaching task</intervention_name>
    <description>Similar to a hand reaching task in which participants were asked to reach to a tea-cup, in a visuomotor leg reaching task, participants will be seated and given real-time visual feedback about their leg movements via a cursor display on a computer screen. The task is to control a foot mouse/marker attached to the foot and move the cursor from a start location to the target displayed on a wall screen. Three different targets, equidistant from the start location at top, top-left, and top-right screen positions, will be used for leg reaching. In each trial, one of three targets will be randomly presented and subjects will be instructed to make forward, or rightward, or leftward foot reaches to guide the cursor to one of the targets. Throughout the entire experiment, subjects are blocked from viewing leg movements by a cardboard.</description>
    <arm_group_label>Chronic Stroke</arm_group_label>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Multiple Sclerosis</arm_group_label>
    <other_name>Leg reaching task</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Three cohorts, including individuals with chronic stroke and multiple sclerosis, and&#xD;
        healthy adults.will be recruited via research flyers from communities around Great Houston&#xD;
        areas in Texas.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults have no ongoing neurological, musculoskeletal issues.&#xD;
&#xD;
          -  Individuals with chronic stroke had medical history of a unilateral stroke occurring ≥&#xD;
             6 months prior to enrollment.&#xD;
&#xD;
          -  Individuals have multiple sclerosis disease diagnosed by his/her physician&#xD;
&#xD;
          -  MRI or CT evidence from the imaging report shown that the stroke and multiple&#xD;
             sclerosis disease primarily involve cortical and subcortical regions.&#xD;
&#xD;
          -  Individuals with chronic stroke have hemiparesis involving the lower extremity.&#xD;
&#xD;
          -  Individuals with chronic stroke or multiple sclerosis have no passive range of motion&#xD;
             limitation in bilateral hips and knees. Limitation of ankle passive range of motion to&#xD;
             10 degrees of dorsiflexion or less.&#xD;
&#xD;
          -  Visual acuity can be corrected by glasses or contact lens to 20/20.&#xD;
&#xD;
          -  Able to walk independently with/without assistant devices for 10 meters.&#xD;
&#xD;
          -  Able to maintain standing position without any assistance for more than 30 sec.&#xD;
&#xD;
          -  Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  MRI or CT evidence of involvement of the basal ganglia or cerebellum, or evidence of&#xD;
             any other brain damage or malignant neoplasm or tumors.&#xD;
&#xD;
          -  Have any metal implants, cardiac pacemakers, or history of seizures.&#xD;
&#xD;
          -  Ongoing orthopedic or other neuromuscular disorders that will restrict exercise&#xD;
             training.&#xD;
&#xD;
          -  Any vestibular dysfunction or unstable angina.&#xD;
&#xD;
          -  Significant cognitive deficits (inability to follow a 2-step command) or severe&#xD;
             receptive or global aphasia*&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Shih-Chiao Tseng, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Woman's University School of Physical Therapy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shih-Chiao Tseng, PT, PhD</last_name>
    <phone>713-794-2309</phone>
    <email>stseng@twu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Texas Woman's University</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shih-Chiao Tseng, PT, PhD</last_name>
      <phone>703-794-2309</phone>
      <email>stseng@twu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Woman's University</investigator_affiliation>
    <investigator_full_name>Shih-Chiao Tseng</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT04503187/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04503187
org study id: TWU Houston#17203
nct id: NCT04503187
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke survivors frequently show persistent gait deficits in their chronic stages even after
      years of intensive rehabilitation. This may be caused by diminished capability of
      re-acquiring motor skills post stroke. Thus, the overall purpose of this research project is
      to examine stroke survivors' capability of learning a novel leg task over 3 visits, 1-2 weeks
      apart. The capability of learning a new skill is then correlated with the individual's
      neurological functions (nerve activity and movement coordination) and her/his gait
      performance (gait speed, gait symmetry, and force production).
The walking after stroke called "hemiparetic gait" is characterized by slow and asymmetrical
      steps with poor motor control on the paretic leg while paradoxically increasing the cost of
      energy expenditure. Biomechanical evidence shows that impaired gait performance for people
      with chronic stroke is not solely the result of the loss of muscle strength, but involves
      complicated movement discoordination across multiple joints in the affected leg. This has
      been taken to indicate a persistent motor control deficit in the paretic leg post stroke.
      Recent imaging studies suggest that the persistent motor control deficit after stroke may be
      the result of the disruption of motor memory consolidation, a process by which a
      newly-learned motor skill is transformed from a fragile state to a stable state and is
      "saved" in our brain afterward. This indicates that the same brain area responsible for
      controlling motor activity is also involved in memorizing newly-learned skills during the
      early stage of motor learning. Presence of persistent motor control deficits in the chronic
      stage may be attributed to the fact that damage to the brain cortex significantly impacts the
      ability of acquiring motor skills and consequentially defers the improvement of motor
      function, including gait.
observational model: Cohort
time perspective: Prospective
measure: Changes in movement errors
time frame: During the first session of learning visuomotor leg reaching task, 24-hour after the first session, and 7-days after the first learning learning session
description: Average movement error will be calculated as the angular deviation of the foot path from a straight line path to the target at the time of peak velocity in each trial.
measure: Peripheral nerve activity
time frame: During the first session of learning visuomotor leg reaching task
description: A surface electrode will be placed on the calf muscle in one leg. Then a low-intensity of electrical stimulation will be delivered to a nerve behind the knee to trigger the motor responses.
measure: Walking performance
time frame: Before the first session of learning visuomotor leg reaching task
description: Gait speed will be calculated during overground walking
measure: Mini-mental State Examination
time frame: Before the first session of learning visuomotor leg reaching task
description: A standardized questionnaires to evaluate the cognitive function consisting of 11 items with a possible summed score ranging from zero to 30. The most widely accepted and frequently used cutoff score for the MMSE is 23, with scores of 23 or lower indicating the presence of cognitive impairment. A higher score means a better cognitive function.
measure: Fugl-Meyer Lower Extremity Function Assessment
time frame: Before the first session of learning visuomotor leg reaching task
description: A standardized questionnaires to evaluate the lower extremity motor function consisting of movement, coordination, and reflex assessments at hip, knee, and ankle. Possible summed scores range from zero to 34. Higher scores indicate higher and better motor function.
arm group label: Chronic Stroke
description: Participants who suffered a single event of cerebral vascular accident at least six months ago before study enrollment.
arm group label: Multiple Sclerosis
description: Participants who has been diagnosed with multiple sclerosis
arm group label: Healthy control
description: Age-matched healthy adults who are self-reported healthy and has no known musculoskeletal, neuromuscular, and cardiovascular diseases.
intervention type: Behavioral
intervention name: Visuomotor leg reaching task
description: Similar to a hand reaching task in which participants were asked to reach to a tea-cup, in a visuomotor leg reaching task, participants will be seated and given real-time visual feedback about their leg movements via a cursor display on a computer screen. The task is to control a foot mouse/marker attached to the foot and move the cursor from a start location to the target displayed on a wall screen. Three different targets, equidistant from the start location at top, top-left, and top-right screen positions, will be used for leg reaching. In each trial, one of three targets will be randomly presented and subjects will be instructed to make forward, or rightward, or leftward foot reaches to guide the cursor to one of the targets. Throughout the entire experiment, subjects are blocked from viewing leg movements by a cardboard.
arm group label: Chronic Stroke
arm group label: Healthy control
arm group label: Multiple Sclerosis
other name: Leg reaching task
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
last name: Shih-Chiao Tseng, PT, PhD
role: Principal Investigator
affiliation: Texas Woman's University School of Physical Therapy
last name: Shih-Chiao Tseng, PT, PhD
phone: 713-794-2309
email: stseng@twu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas Woman's University
investigator full name: Shih-Chiao Tseng
investigator title: Associate Professor
mesh term: Multiple Sclerosis
mesh term: Nervous System Diseases
sharing ipd: No
provided document: 