<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/NCT03002285</url>
  </required_header>
  <id_info>
    <org_study_id>14652713.9.0000.0082</org_study_id>
    <nct_id>NCT03002285</nct_id>
  </id_info>
  <brief_title>Fitts Law in People With Cerebral Palsy</brief_title>
  <official_title>Evaluation of Speed-accuracy Trade-off in a Computer Task in Individuals With Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Cerebral palsy (CP) is a non-progressive disorder in the brain which makes the&#xD;
      control and execution of movements difficult. One of the possible ways to analyze motor&#xD;
      control in these individuals could be through analysis of movement speed and accuracy.&#xD;
      Objective: To verify the speed-accuracy trade-off in individuals with CP. Method: 96&#xD;
      individuals were evaluated, 48 with CP and 48 with typical development (TD), matched by age&#xD;
      and sex. The software used was the &quot;Fitts' Reciprocal Aiming Task v.1.0 (Horizontal)&quot;,&#xD;
      performed on a computer using an external optical mouse, with progressive indices of&#xD;
      difficulty (IDs): ID2, ID4a and ID4b. Each index of difficulty was performed three times and&#xD;
      the total time/touches captured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The software used in this study was &quot;Fitts' Reciprocal Aiming Task v.1.0 (Horizontal)&quot;&#xD;
      developed by Okazaki, in the public domain and available on the Internet, which was performed&#xD;
      on a Toshiba notebook®, model Satellite A60-S1561 System Unit, with the use of an external&#xD;
      optical mouse, Fortrek® OM-302.&#xD;
&#xD;
      This instrument can be used to verify motor control through analysis of the speed and&#xD;
      accuracy of movement, which can be determined through the log-linear relation between&#xD;
      movement time and task difficulty using a mathematical equation, and analyzed by Fitts' law,&#xD;
      which describes the relation between movement accuracy and speed, associated with target size&#xD;
      and distance11. Thus, the task used in this study was composed of targets of different sizes,&#xD;
      being that the smaller targets require more time to execute due to the necessity of increased&#xD;
      accuracy and, if the distance between targets reduces, the speed of movement becomes greater&#xD;
      and the accuracy decreases.&#xD;
&#xD;
      In relation to target size (W) and distance between targets (D), the equation log2 (2D/W)&#xD;
      results in an index of difficulty (ID), where the higher the ID, the more difficult the task,&#xD;
      a fact that necessitates greater movement time.&#xD;
&#xD;
      To evaluate the speed and accuracy, two different indices of difficulty were used in this&#xD;
      study (ID2 and ID4). The difficulty level was increased by changing the width and distance&#xD;
      between the bars. In addition, ID4 was used in two different ways (ID4a and ID4b), for which&#xD;
      the distance between the bars and the width were different, but the ID was maintained.&#xD;
&#xD;
      3 Procedure and design The experiment was composed of three trials at each of the two IDs: 2&#xD;
      and 4 (ID 4 had two kinds of measurement - ID4a and ID4b), and the participants performed the&#xD;
      tasks individually in a room, with only the evaluator present, seated on a chair (or their&#xD;
      own wheelchair), which was adjusted in height according to the needs of the individual. A&#xD;
      footrest was available, when necessary. The computer was placed on a table, and each&#xD;
      participant was given instructions and presented with the task, in which the individual,&#xD;
      after hearing an alarm from the computer, was required to click with an external mouse cursor&#xD;
      on two parallel bars which were arranged vertically, intermittently, with the greatest speed&#xD;
      and accuracy possible, for a period of 10 seconds, followed by a second alarm which indicated&#xD;
      the end of the attempt.&#xD;
&#xD;
      Directly following the attempt, the total movement time was registered, by dividing the&#xD;
      seconds obtained in each attempt by the number of &quot;clicks&quot; on targets. If more than two&#xD;
      clicks were wrong, the individual repeated the task.&#xD;
&#xD;
      Procedure and design The experiment was composed of three trials at each of the two IDs: 2&#xD;
      and 4 (ID 4 had two kinds of measurement - ID4a and ID4b), and the participants performed the&#xD;
      tasks individually in a room, with only the evaluator present, seated on a chair (or their&#xD;
      own wheelchair), which was adjusted in height according to the needs of the individual. A&#xD;
      footrest was available, when necessary. The computer was placed on a table, and each&#xD;
      participant was given instructions and presented with the task, in which the individual,&#xD;
      after hearing an alarm from the computer, was required to click with an external mouse cursor&#xD;
      on two parallel bars which were arranged vertically, intermittently, with the greatest speed&#xD;
      and accuracy possible, for a period of 10 seconds, followed by a second alarm which indicated&#xD;
      the end of the attempt.&#xD;
&#xD;
      Directly following the attempt, the total movement time was registered, by dividing the&#xD;
      seconds obtained in each attempt by the number of &quot;clicks&quot; on targets. If more than two&#xD;
      clicks were wrong, the individual repeated the task.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motor control test by using a fitts law task in computational task</measure>
    <time_frame>one day</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Cerebral Palsy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group with Cerebral Palsy that performed the Fitts law in a computer task</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group with typical development that performed the Fitts law in a computer task</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cerebral Palsy group</intervention_name>
    <description>Group with Cerebral Palsy that performed the Fitts law in a computer task</description>
    <arm_group_label>Cerebral Palsy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Group with typical development that performed the Fitts law in a computer task</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medical diagnosis of CP;&#xD;
&#xD;
          -  levels I to IV according to the GMFCS;&#xD;
&#xD;
          -  levels I to III according to MACS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of surgery or a chemical neuromuscular blockade in the upper limbs within six&#xD;
             months prior to participation in the study;&#xD;
&#xD;
          -  lack of comprehension of the experimental instructions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos BM Monteiro, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Carlos Bandeira de Mello Monteiro</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>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03002285
org study id: 14652713.9.0000.0082
nct id: NCT03002285
lead sponsor: 
has dmc: No
Introduction: Cerebral palsy (CP) is a non-progressive disorder in the brain which makes the
      control and execution of movements difficult. One of the possible ways to analyze motor
      control in these individuals could be through analysis of movement speed and accuracy.
      Objective: To verify the speed-accuracy trade-off in individuals with CP. Method: 96
      individuals were evaluated, 48 with CP and 48 with typical development (TD), matched by age
      and sex. The software used was the "Fitts' Reciprocal Aiming Task v.1.0 (Horizontal)",
      performed on a computer using an external optical mouse, with progressive indices of
      difficulty (IDs): ID2, ID4a and ID4b. Each index of difficulty was performed three times and
      the total time/touches captured.
The software used in this study was "Fitts' Reciprocal Aiming Task v.1.0 (Horizontal)"
      developed by Okazaki, in the public domain and available on the Internet, which was performed
      on a Toshiba notebook®, model Satellite A60-S1561 System Unit, with the use of an external
      optical mouse, Fortrek® OM-302.

      This instrument can be used to verify motor control through analysis of the speed and
      accuracy of movement, which can be determined through the log-linear relation between
      movement time and task difficulty using a mathematical equation, and analyzed by Fitts' law,
      which describes the relation between movement accuracy and speed, associated with target size
      and distance11. Thus, the task used in this study was composed of targets of different sizes,
      being that the smaller targets require more time to execute due to the necessity of increased
      accuracy and, if the distance between targets reduces, the speed of movement becomes greater
      and the accuracy decreases.

      In relation to target size (W) and distance between targets (D), the equation log2 (2D/W)
      results in an index of difficulty (ID), where the higher the ID, the more difficult the task,
      a fact that necessitates greater movement time.

      To evaluate the speed and accuracy, two different indices of difficulty were used in this
      study (ID2 and ID4). The difficulty level was increased by changing the width and distance
      between the bars. In addition, ID4 was used in two different ways (ID4a and ID4b), for which
      the distance between the bars and the width were different, but the ID was maintained.

      3 Procedure and design The experiment was composed of three trials at each of the two IDs: 2
      and 4 (ID 4 had two kinds of measurement - ID4a and ID4b), and the participants performed the
      tasks individually in a room, with only the evaluator present, seated on a chair (or their
      own wheelchair), which was adjusted in height according to the needs of the individual. A
      footrest was available, when necessary. The computer was placed on a table, and each
      participant was given instructions and presented with the task, in which the individual,
      after hearing an alarm from the computer, was required to click with an external mouse cursor
      on two parallel bars which were arranged vertically, intermittently, with the greatest speed
      and accuracy possible, for a period of 10 seconds, followed by a second alarm which indicated
      the end of the attempt.

      Directly following the attempt, the total movement time was registered, by dividing the
      seconds obtained in each attempt by the number of "clicks" on targets. If more than two
      clicks were wrong, the individual repeated the task.

      Procedure and design The experiment was composed of three trials at each of the two IDs: 2
      and 4 (ID 4 had two kinds of measurement - ID4a and ID4b), and the participants performed the
      tasks individually in a room, with only the evaluator present, seated on a chair (or their
      own wheelchair), which was adjusted in height according to the needs of the individual. A
      footrest was available, when necessary. The computer was placed on a table, and each
      participant was given instructions and presented with the task, in which the individual,
      after hearing an alarm from the computer, was required to click with an external mouse cursor
      on two parallel bars which were arranged vertically, intermittently, with the greatest speed
      and accuracy possible, for a period of 10 seconds, followed by a second alarm which indicated
      the end of the attempt.

      Directly following the attempt, the total movement time was registered, by dividing the
      seconds obtained in each attempt by the number of "clicks" on targets. If more than two
      clicks were wrong, the individual repeated the task.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Motor control test by using a fitts law task in computational task
time frame: one day
arm group label: Cerebral Palsy group
arm group type: Experimental
description: Group with Cerebral Palsy that performed the Fitts law in a computer task
arm group label: Control group
arm group type: Active Comparator
description: Group with typical development that performed the Fitts law in a computer task
intervention type: Behavioral
intervention name: Cerebral Palsy group
description: Group with Cerebral Palsy that performed the Fitts law in a computer task
arm group label: Cerebral Palsy group
intervention type: Behavioral
intervention name: Control group
description: Group with typical development that performed the Fitts law in a computer task
arm group label: Control group
criteria: 
gender: All
minimum age: 7 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carlos BM Monteiro, Ph.D.
role: Principal Investigator
affiliation: University of Sao Paulo
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Carlos Bandeira de Mello Monteiro
investigator title: Associate Professor
mesh term: Cerebral Palsy
sharing ipd: Undecided