search
Back to results

Fitts Law in People With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cerebral Palsy group
Control group
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

7 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • medical diagnosis of CP;
  • levels I to IV according to the GMFCS;
  • levels I to III according to MACS.

Exclusion Criteria:

  • presence of surgery or a chemical neuromuscular blockade in the upper limbs within six months prior to participation in the study;
  • lack of comprehension of the experimental instructions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cerebral Palsy group

    Control group

    Arm Description

    Group with Cerebral Palsy that performed the Fitts law in a computer task

    Group with typical development that performed the Fitts law in a computer task

    Outcomes

    Primary Outcome Measures

    Motor control test by using a fitts law task in computational task

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2016
    Last Updated
    December 20, 2016
    Sponsor
    University of Sao Paulo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03002285
    Brief Title
    Fitts Law in People With Cerebral Palsy
    Official Title
    Evaluation of Speed-accuracy Trade-off in a Computer Task in Individuals With Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cerebral Palsy group
    Arm Type
    Experimental
    Arm Description
    Group with Cerebral Palsy that performed the Fitts law in a computer task
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Group with typical development that performed the Fitts law in a computer task
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cerebral Palsy group
    Intervention Description
    Group with Cerebral Palsy that performed the Fitts law in a computer task
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control group
    Intervention Description
    Group with typical development that performed the Fitts law in a computer task
    Primary Outcome Measure Information:
    Title
    Motor control test by using a fitts law task in computational task
    Time Frame
    one day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: medical diagnosis of CP; levels I to IV according to the GMFCS; levels I to III according to MACS. Exclusion Criteria: presence of surgery or a chemical neuromuscular blockade in the upper limbs within six months prior to participation in the study; lack of comprehension of the experimental instructions.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos BM Monteiro, Ph.D.
    Organizational Affiliation
    University of Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28750603
    Citation
    Fernani DCGL, Prado MTA, da Silva TD, Massetti T, de Abreu LC, Magalhaes FH, Dawes H, de Mello Monteiro CB. Evaluation of speed-accuracy trade-off in a computer task in individuals with cerebral palsy: a cross-sectional study. BMC Neurol. 2017 Jul 27;17(1):143. doi: 10.1186/s12883-017-0920-4.
    Results Reference
    derived

    Learn more about this trial

    Fitts Law in People With Cerebral Palsy

    We'll reach out to this number within 24 hrs