xml: <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/NCT05988775</url>
    </required_header>
    <id_info>
      <org_study_id>AU-HEA-OE-20210610</org_study_id>
      <nct_id>NCT05988775</nct_id>
    </id_info>
    <brief_title>Ipsilateral Transfer of Motor Skill From Lower to Upper Limb in Healthy Adults</brief_title>
    <official_title>Ipsilateral Transfer of Motor Skill From Lower to Upper Limb in Healthy Adults: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ariel University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ariel University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To determine whether there is an ipsilateral transfer of motor skill from the lower to the&#xD;
        upper limb in healthy adults.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In a single-blind randomized controlled study,45 healthy subjects were randomly allocated to&#xD;
        one of three single intervention groups: (1) &quot;Leg Training&quot; group (LT) (15 participants)&#xD;
        practiced reaching movement (RM) sequences with the non-dominant left lower limb towards the&#xD;
        numbered illuminating switch; (2) &quot;Sequence observation&quot; group (SO) (15 participants)&#xD;
        observed the identical sequences of the illuminating switches (Switches Observation (SO)&#xD;
        group); and (3) &quot;Nature Movie Watching&quot; (MW) group. (15 participants) watched a neutral&#xD;
        nature video. Each subject was asked to attend two consecutive sessions, day after day. The&#xD;
        first session included familiarization practice of the motor task, a pretest, a single&#xD;
        session intervention (according to group randomization), and a posttest. Subjects&#xD;
        participated in two sessions. The second session included a retest, 24 hours after the&#xD;
        training. The predefined sequence consisted of six reaching movements in the following order&#xD;
        of switches: 1, 4, 3, 5, 4, 2.&#xD;
  &#xD;
        Recording apparatus used in tests (pretest, posttest, and retest) and training: A custom-made&#xD;
        testing device was set up on a rectangular table with a smooth laminated tabletop of 105 cm ×&#xD;
        80 cm and adjustable height. Five switch-led units of 5 cm × 8 cm × 5 cm, each composed of a&#xD;
        large push-button switch and a red light-emitting diode (LED), attached to the tabletop in a&#xD;
        38-cm radius half circle, successively numbered from 1 to 5. The system was operated by a&#xD;
        desktop computer, interfaced with a data acquisition card of LABVIEW software. The algorithm&#xD;
        allowed parameters selection of LED activation (illumination) sequence, duration of RM, the&#xD;
        delay between RMs, and the number of RM repetitions. Activation of a specific unit LED was a&#xD;
        cue for the subject to reach toward that unit and press the push-button switch. Reaching the&#xD;
        switch of an activated unit deactivated it, and the response time, between the activated and&#xD;
        deactivated LED, was recorded.&#xD;
  &#xD;
        Tests (motor tasks): The non-dominant left arm was tested. Motor task: The subjects performed&#xD;
        a sequential movement task on a table with push button switches with lights sequentially&#xD;
        turning on to indicate the order. Each switch lit up for 1 second, or until hit. Initially,&#xD;
        the participants were required to perform 3 sequences to familiarize themselves with the&#xD;
        setup, the task, and the sequence. Then, they performed the pre-test which consisted of two&#xD;
        blocks of 5 sequences, i.e. 10 sequences, with a 30s break between blocks. After this, the&#xD;
        participants underwent one of the following predetermined interventions groups:&#xD;
  &#xD;
          1. &quot;Leg Training&quot; Participants sat on a chair with their left heel resting on the table&#xD;
             with the push button switches. They performed 10 blocks of the aforementioned sequence&#xD;
             with their leg, with a 30s break between each block.&#xD;
  &#xD;
          2. &quot;Sequence observation&quot; Participants observed 10 blocks of the identical sequence with&#xD;
             the lights alternating automatically, with a 30s break between each block.&#xD;
  &#xD;
          3. &quot;Nature movie watching&quot; Participants watched a &quot;scenic relaxation film&quot; for 10 minutes,&#xD;
             with a 30s break after every minute.&#xD;
  &#xD;
        Two outcome measures were used: 1. response time (s), 2. failure (%) of the reaching&#xD;
        movements, defined as failure to reach the switch in the allotted time (1 sec), or pressing&#xD;
        the wrong buzzer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 8, 2022</start_date>
    <completion_date type="Actual">March 12, 2023</completion_date>
    <primary_completion_date type="Actual">March 9, 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>randomized controlled trial (RCT)</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in response time (s) from baseline to post-test</measure>
      <time_frame>baseline - before the training session, post-test - immediately after the training session</time_frame>
      <description>Average time of movements, measured from the time the switch lights up until it is pressed</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in response time (s) from post-test to follow up</measure>
      <time_frame>post-test - immediately after the training session, follow up - 24 hours after the training session</time_frame>
      <description>Average time of movements, measured from the time the switch lights up until it is pressed</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in response time (s) from baseline to follow up</measure>
      <time_frame>baseline - before the training session, follow up - 24 hours after the training session</time_frame>
      <description>Average time of movements, measured from the time the switch lights up until it is pressed</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in failure (%) from baseline to post-test</measure>
      <time_frame>baseline - before the training session, post-test - immediately after the training session</time_frame>
      <description>Percentage of the reaching movements in which the participant failed to reach the switch in the allotted time (1 sec) or pressed the wrong buzzer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in failure (%) from post-test to follow up</measure>
      <time_frame>post-test - immediately after the training session, follow up - 24 hours after the training session</time_frame>
      <description>Percentage of the reaching movements in which the participant failed to reach the switch in the allotted time (1 sec) or pressed the wrong buzzer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in failure (%) from base line to follow up</measure>
      <time_frame>baseline - before the training session, follow up - 24 hours after the training session</time_frame>
      <description>Percentage of the reaching movements in which the participant failed to reach the switch in the allotted time (1 sec) or pressed the wrong buzzer.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">45</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Leg training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants sat on a chair with their left heel resting on the table with the push button switches. participants performed 10 blocks of the aforementioned sequence with their leg, with a 30s break between each block.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sequence observation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nature movie watching</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants watched a &quot;scenic relaxation film,&quot; for 10 minutes, with a 30s break after every minute.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Leg training</intervention_name>
      <description>Participants sat on a chair with their left heel resting on the table with the push button switches. participants performed 10 blocks of the aforementioned sequence with their leg, with a 30s break between each block.</description>
      <arm_group_label>Leg training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Sequence observation</intervention_name>
      <description>Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.</description>
      <arm_group_label>Sequence observation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Nature movie watching</intervention_name>
      <description>Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.</description>
      <arm_group_label>Nature movie watching</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aged between 20 and 35&#xD;
  &#xD;
            -  right-hand dominant&#xD;
  &#xD;
            -  healthy according to self-report&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  musculoskeletal problems or any other problem that may interfere with the performance&#xD;
               of the task (extension of an arm or leg while sitting).&#xD;
  &#xD;
            -  pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Silvi Frenkel-Toledo, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Study Principal Investigator</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ariel University</name>
        <address>
          <city>Ariel</city>
          <country>Israel</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>May 2022</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ipsilateral transfer</keyword>
    <keyword>motor performance</keyword>
    <keyword>lower limb</keyword>
    <keyword>upper limb</keyword>
    <keyword>reaching sequence</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The datasets (Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code generated during and/or analyzed during the current study) will be available from the corresponding author on reasonable request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988775
  org study id: AU-HEA-OE-20210610
  nct id: NCT05988775
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To determine whether there is an ipsilateral transfer of motor skill from the lower to the
        upper limb in healthy adults.
  In a single-blind randomized controlled study,45 healthy subjects were randomly allocated to
        one of three single intervention groups: (1) "Leg Training" group (LT) (15 participants)
        practiced reaching movement (RM) sequences with the non-dominant left lower limb towards the
        numbered illuminating switch; (2) "Sequence observation" group (SO) (15 participants)
        observed the identical sequences of the illuminating switches (Switches Observation (SO)
        group); and (3) "Nature Movie Watching" (MW) group. (15 participants) watched a neutral
        nature video. Each subject was asked to attend two consecutive sessions, day after day. The
        first session included familiarization practice of the motor task, a pretest, a single
        session intervention (according to group randomization), and a posttest. Subjects
        participated in two sessions. The second session included a retest, 24 hours after the
        training. The predefined sequence consisted of six reaching movements in the following order
        of switches: 1, 4, 3, 5, 4, 2.
  
        Recording apparatus used in tests (pretest, posttest, and retest) and training: A custom-made
        testing device was set up on a rectangular table with a smooth laminated tabletop of 105 cm ×
        80 cm and adjustable height. Five switch-led units of 5 cm × 8 cm × 5 cm, each composed of a
        large push-button switch and a red light-emitting diode (LED), attached to the tabletop in a
        38-cm radius half circle, successively numbered from 1 to 5. The system was operated by a
        desktop computer, interfaced with a data acquisition card of LABVIEW software. The algorithm
        allowed parameters selection of LED activation (illumination) sequence, duration of RM, the
        delay between RMs, and the number of RM repetitions. Activation of a specific unit LED was a
        cue for the subject to reach toward that unit and press the push-button switch. Reaching the
        switch of an activated unit deactivated it, and the response time, between the activated and
        deactivated LED, was recorded.
  
        Tests (motor tasks): The non-dominant left arm was tested. Motor task: The subjects performed
        a sequential movement task on a table with push button switches with lights sequentially
        turning on to indicate the order. Each switch lit up for 1 second, or until hit. Initially,
        the participants were required to perform 3 sequences to familiarize themselves with the
        setup, the task, and the sequence. Then, they performed the pre-test which consisted of two
        blocks of 5 sequences, i.e. 10 sequences, with a 30s break between blocks. After this, the
        participants underwent one of the following predetermined interventions groups:
  
          1. "Leg Training" Participants sat on a chair with their left heel resting on the table
             with the push button switches. They performed 10 blocks of the aforementioned sequence
             with their leg, with a 30s break between each block.
  
          2. "Sequence observation" Participants observed 10 blocks of the identical sequence with
             the lights alternating automatically, with a 30s break between each block.
  
          3. "Nature movie watching" Participants watched a "scenic relaxation film" for 10 minutes,
             with a 30s break after every minute.
  
        Two outcome measures were used: 1. response time (s), 2. failure (%) of the reaching
        movements, defined as failure to reach the switch in the allotted time (1 sec), or pressing
        the wrong buzzer.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized controlled trial (RCT)
  primary purpose: Other
  masking: Single (Participant)
  measure: Change in response time (s) from baseline to post-test
  time frame: baseline - before the training session, post-test - immediately after the training session
  description: Average time of movements, measured from the time the switch lights up until it is pressed
  measure: Change in response time (s) from post-test to follow up
  time frame: post-test - immediately after the training session, follow up - 24 hours after the training session
  description: Average time of movements, measured from the time the switch lights up until it is pressed
  measure: Change in response time (s) from baseline to follow up
  time frame: baseline - before the training session, follow up - 24 hours after the training session
  description: Average time of movements, measured from the time the switch lights up until it is pressed
  measure: Change in failure (%) from baseline to post-test
  time frame: baseline - before the training session, post-test - immediately after the training session
  description: Percentage of the reaching movements in which the participant failed to reach the switch in the allotted time (1 sec) or pressed the wrong buzzer.
  measure: Change in failure (%) from post-test to follow up
  time frame: post-test - immediately after the training session, follow up - 24 hours after the training session
  description: Percentage of the reaching movements in which the participant failed to reach the switch in the allotted time (1 sec) or pressed the wrong buzzer.
  measure: Change in failure (%) from base line to follow up
  time frame: baseline - before the training session, follow up - 24 hours after the training session
  description: Percentage of the reaching movements in which the participant failed to reach the switch in the allotted time (1 sec) or pressed the wrong buzzer.
  arm group label: Leg training
  arm group type: Experimental
  description: Participants sat on a chair with their left heel resting on the table with the push button switches. participants performed 10 blocks of the aforementioned sequence with their leg, with a 30s break between each block.
  arm group label: Sequence observation
  arm group type: Active Comparator
  description: Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.
  arm group label: Nature movie watching
  arm group type: Other
  description: Participants watched a "scenic relaxation film," for 10 minutes, with a 30s break after every minute.
  intervention type: Behavioral
  intervention name: Leg training
  description: Participants sat on a chair with their left heel resting on the table with the push button switches. participants performed 10 blocks of the aforementioned sequence with their leg, with a 30s break between each block.
  arm group label: Leg training
  intervention type: Behavioral
  intervention name: Sequence observation
  description: Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.
  arm group label: Sequence observation
  intervention type: Other
  intervention name: Nature movie watching
  description: Participants observed 10 blocks of the sequence with the lights alternating automatically, with a 30s break between each block.
  arm group label: Nature movie watching
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Silvi Frenkel-Toledo, PhD
  role: Principal Investigator
  affiliation: Study Principal Investigator
  facility: 
  country: Israel
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: The datasets (Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code generated during and/or analyzed during the current study) will be available from the corresponding author on reasonable request.