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The Effect of Virtual Reality on Motor Functioning and Participation Abilities Among Children With DCD

Primary Purpose

Developmental Coordination Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality Timocco
Conventional OT intervention
Sponsored by
Clalit Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Coordination Disorder

Eligibility Criteria

4 Years - 6 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Children,
  • native Hebrew speakers, between the ages of 4 and 6 diagnosed with DCD.

Exclusion Criteria:

  • Children with complicated special needs (e.g., limited cognitive abilities, CP, ASD),
  • children who received occupational or physical therapy interventions in the last 12 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Virtual Reality Timocco

    Conventional OT intervention

    Arm Description

    The study group will integrate the use of Timocco in occupational therapy sessions. The session will begin with 15 minutes of spatial activity involving sensory-motor practice, 15 minutes of activity in a virtual environment, and 15 minutes of structured activity at a desk.

    The control group will be given conventional occupational therapy without using Timocco. In order to ensure that the therapy sessions in this group have a structure similar to that one used in the study group, each session will include 25 to 30 minutes of spatial sensory-motor activity, followed by 15 to 20 minutes of structured practice at a desk.

    Outcomes

    Primary Outcome Measures

    The score in Motor and participation assessments (Henderson, S. & Sugden, D. 1992)
    Score in Timocco virtual reality system (number of wrong moves; Correct moves;response time)
    data will be gathered using Timocco for the entire intervention

    Secondary Outcome Measures

    DCD-Q (BN. Wilson, BJ. Kaplan, SG. Crawford and G. Roberts, 2009)
    The questionnaire will be filled once at the beginning, once again at the end of phase 1 (in the clinic) , and last time after home practice (the second phase).
    Participation questionnaire (Yarus, 2010)
    The questionnaire will be filled once at the beginning, once again at the end of phase 1 (in the clinic) , and last time after home practice (the second phase).
    DTVP-2 (developmental test of visual perception, 1993))
    Screening test.
    Satisfaction questionnaire

    Full Information

    First Posted
    March 29, 2015
    Last Updated
    July 20, 2015
    Sponsor
    Clalit Health Services
    Collaborators
    Timocco Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02504385
    Brief Title
    The Effect of Virtual Reality on Motor Functioning and Participation Abilities Among Children With DCD
    Official Title
    The Effect of Timocco's Virtual Reality Environment on the Motor Functioning and Participation Abilities Among Children With DCD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    August 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clalit Health Services
    Collaborators
    Timocco Ltd

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The subjet of this study is to explore the effect of using virtual reality environment at the clinic and at home (using Timocco) on the motor and participation abilities of children with DCD (Developmental Coordination Disorder). The study will examine the efficacy of using virtual reality gaming environment (Timocco) for treating children with DCD and the use of remote therapy, by shifting the focus of therapy from the clinic to the home environment, using the remote control system of Timocco for home practice.
    Detailed Description
    The efficacy of using VR (Virtual Reality) as a therapeutic tool as an integral part of Occupational Therapy intervention will be examined in this study. The study will be conducted in two stages: the first will be conducted at the Child Development Center of the Clalit HMO (Health Maintenance Organization), and the second will take place in the child's home. The first intervention will take approximately 8 to 10 weeks, during which eight data collection sessions will be conducted, each of 45 minutes duration. The study group will integrate the use of Timocco in occupational therapy sessions while the control group will be given conventional occupational therapy without using Timocco. In the second intervention, the study group will be given access to the virtual-reality environment of Timocco to be used at home, and will not include therapy sessions at the Child Development Center. An assessment before and after intervention will be held for both groups for comparison.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Developmental Coordination Disorder

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual Reality Timocco
    Arm Type
    Experimental
    Arm Description
    The study group will integrate the use of Timocco in occupational therapy sessions. The session will begin with 15 minutes of spatial activity involving sensory-motor practice, 15 minutes of activity in a virtual environment, and 15 minutes of structured activity at a desk.
    Arm Title
    Conventional OT intervention
    Arm Type
    Active Comparator
    Arm Description
    The control group will be given conventional occupational therapy without using Timocco. In order to ensure that the therapy sessions in this group have a structure similar to that one used in the study group, each session will include 25 to 30 minutes of spatial sensory-motor activity, followed by 15 to 20 minutes of structured practice at a desk.
    Intervention Type
    Device
    Intervention Name(s)
    Virtual Reality Timocco
    Intervention Description
    Timocco virtual reality system is a motion based comuter games that was designed for child development therpay. The children will play Timocco for 15 minutes every session.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional OT intervention
    Intervention Description
    Traditional Occupational Therapy intervention will be givven to the control group.
    Primary Outcome Measure Information:
    Title
    The score in Motor and participation assessments (Henderson, S. & Sugden, D. 1992)
    Time Frame
    up to 18 weeks
    Title
    Score in Timocco virtual reality system (number of wrong moves; Correct moves;response time)
    Description
    data will be gathered using Timocco for the entire intervention
    Time Frame
    up to 18 weeks
    Secondary Outcome Measure Information:
    Title
    DCD-Q (BN. Wilson, BJ. Kaplan, SG. Crawford and G. Roberts, 2009)
    Description
    The questionnaire will be filled once at the beginning, once again at the end of phase 1 (in the clinic) , and last time after home practice (the second phase).
    Time Frame
    up to 18 weeks
    Title
    Participation questionnaire (Yarus, 2010)
    Description
    The questionnaire will be filled once at the beginning, once again at the end of phase 1 (in the clinic) , and last time after home practice (the second phase).
    Time Frame
    up to 18 weeks
    Title
    DTVP-2 (developmental test of visual perception, 1993))
    Description
    Screening test.
    Time Frame
    Baseline
    Title
    Satisfaction questionnaire
    Time Frame
    up to 18 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children, native Hebrew speakers, between the ages of 4 and 6 diagnosed with DCD. Exclusion Criteria: Children with complicated special needs (e.g., limited cognitive abilities, CP, ASD), children who received occupational or physical therapy interventions in the last 12 months.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ruth Terkel-Dawer, M.D
    Phone
    50-7961922
    Ext
    972
    Email
    ruthyte@clalit.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarit Tresser, M.Sc
    Phone
    544428294
    Ext
    972
    Email
    sarit@timocco.com

    12. IPD Sharing Statement

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    The Effect of Virtual Reality on Motor Functioning and Participation Abilities Among Children With DCD

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