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Virtual Reality in Individuals With Duchenne Muscular Dystrophy

Primary Purpose

Duchenne Muscular Dystrophy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DMD gesture task
DMD button-press task
Control group gesture task
Control group button-press task
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Duchenne Muscular Dystrophy

Eligibility Criteria

12 Years - 32 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • medical diagnosis of Duchenne Muscular Dystrophy confirmed by molecular method and/or protein expression in skeletal muscle;
  • signing of an informed consent form from the individual or person legally responsible.

Exclusion Criteria:

  • presence of associated comorbidities;
  • inability in comprehension of the task.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    DMD gesture task

    DMD button-press task

    Control group gesture task

    Control group button-press task

    Arm Description

    Experimental group that made the task using a gesture in front of a webcam

    Experimental group that made the task pressing the button

    Control group that made the task using a gesture in front of a webcam

    Control group that made the task pressing the button

    Outcomes

    Primary Outcome Measures

    Motor Learning test by using a timing coincident task in virtual reality

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2016
    Last Updated
    April 8, 2017
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03002298
    Brief Title
    Virtual Reality in Individuals With Duchenne Muscular Dystrophy
    Official Title
    Motor Learning From Virtual to Natural Environments in Individuals With Duchenne Muscular Dystrophy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    October 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
    With the growing accessibility of computer-assisted technology, one option for rehabilitation programs for individuals with Duchenne muscular dystrophy (DMD) is the use of virtual reality environments to enhance motor practice. Thus, it is important to examine whether performance improvements in the virtual environment generalize to the natural environment. To examine this issue, we had 64 individuals, 32 of which were individuals with DMD and 32 were typically developing individuals. The groups practiced two coincidence timing tasks. In the more tangible button-press task, the individuals were required to 'intercept' a falling virtual object at the moment it reached the interception point by pressing a key on the computer. In the more abstract task, they were instructed to 'intercept' the virtual object by making a hand movement in a virtual environment using a webcam.
    Detailed Description
    The Department of Electronic System Engineering of the Polytechnic School of the University of São Paulo (Brazil) developed the software that superimposes virtual objects over images of real world, captured with a webcam. The coincidence timing task could either have a virtual or a real interface. For the real interface, a keyboard was used. For the virtual interface, a webcam recorded a marker on the table alongside the keyboard of the computer. The images were fed into the computer and analyzed online. Using the custom-made software, it was determined whether or not the participant's hand occluded the marker, which was then fed back to the virtual environment. The coincidence timing task was based on the Bassin Anticipation Timer. To this end, 10 3D-cubes were displayed simultaneously in a vertical column on a monitor. The cubes were turned on (i.e., they changed from white to green) and off sequentially (from top to bottom) until the target cube (i.e., the tenth cube) was reached. The task for the participant was to either press the space bar on the keyboard (i.e., tangible button press task, by physical contact, represented on figure 1A and 1B) or to make a sideward hand gesture as if hitting the target object (i.e., the more abstract gesture task, with no physical contact, represented on the figure 1C and 1D), i.e., occluding the marker at the exact moment the target cube turned green. Participants performed the task individually in a quiet room with only the examiner who gave the instructions present. The computer was placed on a table. The participants were seated in their wheelchair, which was adjusted according to the needs of the individual. The examiner explained the task verbally and gave three demonstrations of how to perform the coincidence timing tasks. The participants were instructed to place the preferred hand (i.e., the less affected hand) on a mark aside to the target (The location was individually adjusted but ranged from 2 to 4 cm from the target). Once the first top cube turned on, the individual had to move his hand to either touch the target key on the keyboard or to make a hitting gesture in front of the webcam, exactly at the moment coinciding with the bottom target cube turning on. Different sounds were provided as feedback for either a hit or miss during acquisition, retention and transfer, the range of error being -200 to 200ms. Participants with DMD and TD were divided into two subgroups randomly: (a) button-press task group (BPT) - in this group during the acquisition phase the participants should press the space button on keyboard to complete the coincidence timing task (more real interface) and (b) gesture task group (GT) - in this group during the acquisition phase the participants should cross a virtual target created by a webcam to complete the coincidence timing task instead of press the computer button (more virtual interface). For all tasks (button-press and gesture), during the acquisition phase, all groups started performing 20 attempts of the coincidence timing task and, after five minutes with no contact with the task, they performed five more repetitions for the retention phase (both phases in slower speed - with the turning on and off of the lights in an interval of 400ms), finally they performed five repetitions for two different transfers phases: the first transfer was performed with a faster speed - 300ms of lights interval (transfer with speed increase - TSI). The second transfer was performed with change task (transfer with exchange of en vironment - TEE) between groups by doing 5 attempts transfer phase in another interface. It means, the group that has done the acquisition phase in button-press task performed the transfer on gesture task and vice versa.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Duchenne Muscular Dystrophy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    DMD gesture task
    Arm Type
    Experimental
    Arm Description
    Experimental group that made the task using a gesture in front of a webcam
    Arm Title
    DMD button-press task
    Arm Type
    Experimental
    Arm Description
    Experimental group that made the task pressing the button
    Arm Title
    Control group gesture task
    Arm Type
    Active Comparator
    Arm Description
    Control group that made the task using a gesture in front of a webcam
    Arm Title
    Control group button-press task
    Arm Type
    Active Comparator
    Arm Description
    Control group that made the task pressing the button
    Intervention Type
    Behavioral
    Intervention Name(s)
    DMD gesture task
    Intervention Description
    Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task
    Intervention Type
    Behavioral
    Intervention Name(s)
    DMD button-press task
    Intervention Description
    Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control group gesture task
    Intervention Description
    Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control group button-press task
    Intervention Description
    Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard
    Primary Outcome Measure Information:
    Title
    Motor Learning test by using a timing coincident task in virtual reality
    Time Frame
    1 day

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    32 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: medical diagnosis of Duchenne Muscular Dystrophy confirmed by molecular method and/or protein expression in skeletal muscle; signing of an informed consent form from the individual or person legally responsible. Exclusion Criteria: presence of associated comorbidities; inability in comprehension of the task.
    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

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