<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/NCT03750045</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 56355416.3.0000.5497</org_study_id>
    <nct_id>NCT03750045</nct_id>
  </id_info>
  <brief_title>Grip Movement Training for Adults With Fine Motor Limitation</brief_title>
  <official_title>Proposal for Grip Movement Training for Adults With Fine Motor Limitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mogi das Cruzes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Mogi das Cruzes</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>
      This study is to test the system composed by a 3D virtual environment, attached to the Leap&#xD;
      Motion, evaluating its effects on the rehabilitation of hand movements in patients with motor&#xD;
      alteration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to elaborate the virtual environment, softwares for 3D content creation were used.&#xD;
      The virtual environment is formed by four phases, each one having three spheres that are&#xD;
      supposed to be inserted, one by one, into a hole located on the scenario floor. Each phase&#xD;
      presents a level of difficulty, from pushing the object to performing the grip movement. By&#xD;
      the end of each phase, a log file is generated with the time spent on it.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">April 12, 2017</completion_date>
  <primary_completion_date type="Actual">August 15, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Virtual environment</measure>
    <time_frame>120 minutes</time_frame>
    <description>The intervention was composed by 8 sessions of 15 minutes each, where the volunteers used a virtual environment attached it to a Leap Motion, which is a sensor that allows to capture the movements that are produced by the hands and reproduce them in a computer through a 3D virtual environment in order to stimulate the execution of their finer movements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wooden box</measure>
    <time_frame>Immediately after at the Session 1, 4 and 8.</time_frame>
    <description>The motor coordination evaluation was made in the first, fourth and eighth sessions. Each volunteer used three balls, or spheres, of different sizes (small, medium, large). The objective was to insert each ball in each orifice. The time was measured with a chronometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamometer JAMAR</measure>
    <time_frame>Immediately after at the Session 1, 4 and 8.</time_frame>
    <description>The grip strength (kgf) was evaluated in the first, fourth and eighth sessions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Hand Injuries and Disorders</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the tests, the volunteers used the access device (Leap Motion) and a computer that were previously installed. The intervention was composed by 8 sessions of 15 minutes each, where the volunteers used a virtual environment attached it to a Leap Motion, which is a sensor that allows to capture the movements that are produced by the hands and reproduce them in a computer through a 3D virtual environment in order to stimulate the execution of their finer movements. The strength (Jamar) and motor coordination (wooden box) evaluations were made in the first, fourth and eighth sessions with the objective of checking the gain progression or not of motion coordination and grip strength.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Jamar</intervention_name>
    <description>The grip strength was evaluated through a dynamometer JAMAR 5030-J, formed by two parallel steel bars, one stationary and a mobile one, which can be adjusted in five different positions. The volunteer was sitting with a neutrally rotated abducted shoulder, elbow flexed at 90°, the forearm in neutral position, and the wrist between 0° and 30° of extension, 0° to 15° of ulnar variance and it was requested that he or she made the grip movement. This test was performed three times with a one-minute-break between each one.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Wooden box</intervention_name>
    <description>The motor coordination evaluation was made through the measurement of the time spent to perform the task of fitting. To do so, a wooden box was built. In its upper part, there is a circular orifice with 6 cm of diameter.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual environment</intervention_name>
    <description>The system proposed is composed by a virtual environment and an access device. The Leap Motion was used as the access device, making it possible to capture the movements performed by the hands.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men and women with age equal or higher than 18 years old;&#xD;
&#xD;
          -  having clinical diagnosis of neurological pathology;&#xD;
&#xD;
          -  presenting fine motor coordination deficit and in grip strength;&#xD;
&#xD;
          -  being able to understand instructions in order to perform the tasks of the virtual&#xD;
             environment;&#xD;
&#xD;
          -  minimum score of 23/24 (from a total of 30) in the Mini-Mental State Examination&#xD;
             (MMSE)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not accepting to participate in this research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Terigi A Scardovelli, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mogi das Cruzes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Terigi Augusto Scardovelli</name>
      <address>
        <city>Mogi das Cruzes</city>
        <state>São Paulo</state>
        <zip>08780-911</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Mogi das Cruzes</investigator_affiliation>
    <investigator_full_name>Terigi Augusto Scardovelli</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hand Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT03750045
org study id: CAAE: 56355416.3.0000.5497
nct id: NCT03750045
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is to test the system composed by a 3D virtual environment, attached to the Leap
      Motion, evaluating its effects on the rehabilitation of hand movements in patients with motor
      alteration.
In order to elaborate the virtual environment, softwares for 3D content creation were used.
      The virtual environment is formed by four phases, each one having three spheres that are
      supposed to be inserted, one by one, into a hole located on the scenario floor. Each phase
      presents a level of difficulty, from pushing the object to performing the grip movement. By
      the end of each phase, a log file is generated with the time spent on it.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Virtual environment
time frame: 120 minutes
description: The intervention was composed by 8 sessions of 15 minutes each, where the volunteers used a virtual environment attached it to a Leap Motion, which is a sensor that allows to capture the movements that are produced by the hands and reproduce them in a computer through a 3D virtual environment in order to stimulate the execution of their finer movements.
measure: Wooden box
time frame: Immediately after at the Session 1, 4 and 8.
description: The motor coordination evaluation was made in the first, fourth and eighth sessions. Each volunteer used three balls, or spheres, of different sizes (small, medium, large). The objective was to insert each ball in each orifice. The time was measured with a chronometer.
measure: Dynamometer JAMAR
time frame: Immediately after at the Session 1, 4 and 8.
description: The grip strength (kgf) was evaluated in the first, fourth and eighth sessions.
arm group label: Experimental group
arm group type: Experimental
description: For the tests, the volunteers used the access device (Leap Motion) and a computer that were previously installed. The intervention was composed by 8 sessions of 15 minutes each, where the volunteers used a virtual environment attached it to a Leap Motion, which is a sensor that allows to capture the movements that are produced by the hands and reproduce them in a computer through a 3D virtual environment in order to stimulate the execution of their finer movements. The strength (Jamar) and motor coordination (wooden box) evaluations were made in the first, fourth and eighth sessions with the objective of checking the gain progression or not of motion coordination and grip strength.
intervention type: Diagnostic Test
intervention name: Jamar
description: The grip strength was evaluated through a dynamometer JAMAR 5030-J, formed by two parallel steel bars, one stationary and a mobile one, which can be adjusted in five different positions. The volunteer was sitting with a neutrally rotated abducted shoulder, elbow flexed at 90°, the forearm in neutral position, and the wrist between 0° and 30° of extension, 0° to 15° of ulnar variance and it was requested that he or she made the grip movement. This test was performed three times with a one-minute-break between each one.
arm group label: Experimental group
intervention type: Diagnostic Test
intervention name: Wooden box
description: The motor coordination evaluation was made through the measurement of the time spent to perform the task of fitting. To do so, a wooden box was built. In its upper part, there is a circular orifice with 6 cm of diameter.
arm group label: Experimental group
intervention type: Other
intervention name: Virtual environment
description: The system proposed is composed by a virtual environment and an access device. The Leap Motion was used as the access device, making it possible to capture the movements performed by the hands.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Terigi A Scardovelli, Ph.D
role: Principal Investigator
affiliation: University of Mogi das Cruzes
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Mogi das Cruzes
investigator full name: Terigi Augusto Scardovelli
investigator title: Principal Investigator
mesh term: Hand Injuries