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Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Down Syndrome focused on measuring Virtual Reality

Eligibility Criteria

11 Years - 28 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • medical diagnosis of DS and the ability to understand the task.

Exclusion Criteria:

  • disorders in cognitive function that would prevent comprehension of the experimental instruction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Down Syndrome Group

    Typical Development Group

    Arm Description

    Group with Down Syndrome

    Control group with typical development

    Outcomes

    Primary Outcome Measures

    Motor Learning test by using a timing coincident task in virtual reality
    Improvement on their performance, by reaching the task with precision

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2016
    Last Updated
    March 24, 2016
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02719600
    Brief Title
    Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome
    Official Title
    Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 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
    Background: Down syndrome (DS) has unique physical, motor and cognitive characteristics. Despite cognitive and motor difficulties, there is a possibility of intervention based on the knowledge of motor learning. However, it is important to study the motor learning process in individuals with DS during a virtual reality task to justify the use of virtual reality to organize intervention programs. The aim of this study was to analyze the motor learning process in individuals with DS during a virtual reality task. Methods: A total of 40 individuals participated in this study, 20 of which were with DS (24 males and 8 females, ranging between 11-28 yrs.) and 20 typically developing individuals matched by age and gender to the individuals with DS. To examine this issue, we used software that uses 3D images and reproduced a coincidence timing task.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Down Syndrome
    Keywords
    Virtual Reality

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Down Syndrome Group
    Arm Type
    Experimental
    Arm Description
    Group with Down Syndrome
    Arm Title
    Typical Development Group
    Arm Type
    Active Comparator
    Arm Description
    Control group with typical development
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual reality
    Intervention Description
    Evaluation of observational motor learning using virtual reality
    Primary Outcome Measure Information:
    Title
    Motor Learning test by using a timing coincident task in virtual reality
    Description
    Improvement on their performance, by reaching the task with precision
    Time Frame
    four months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    28 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: medical diagnosis of DS and the ability to understand the task. Exclusion Criteria: disorders in cognitive function that would prevent comprehension of the experimental instruction
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos B Monteiro, PhD.
    Organizational Affiliation
    University of Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No interest on sharing individual participant data
    Citations:
    PubMed Identifier
    28410583
    Citation
    de Mello Monteiro CB, da Silva TD, de Abreu LC, Fregni F, de Araujo LV, Ferreira FHIB, Leone C. Short-term motor learning through non-immersive virtual reality task in individuals with down syndrome. BMC Neurol. 2017 Apr 14;17(1):71. doi: 10.1186/s12883-017-0852-z.
    Results Reference
    derived

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    Motor Learning Through Virtual Reality Task in Individuals With Down Syndrome

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