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

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ClinicalTrials.gov Identifier: NCT02504385
Recruitment Status : Unknown
Verified July 2015 by Clalit Health Services.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2015
Last Update Posted : July 21, 2015
Sponsor:
Collaborator:
Timocco Ltd
Information provided by (Responsible Party):
Clalit Health Services

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.


Condition or disease Intervention/treatment Phase
Developmental Coordination Disorder Device: Virtual Reality Timocco Other: Conventional OT intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Timocco's Virtual Reality Environment on the Motor Functioning and Participation Abilities Among Children With DCD
Study Start Date : August 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Virtual Reality Timocco
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.
Device: Virtual Reality Timocco
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.

Active Comparator: Conventional OT intervention
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.
Other: Conventional OT intervention
Traditional Occupational Therapy intervention will be givven to the control group.




Primary Outcome Measures :
  1. The score in Motor and participation assessments (Henderson, S. & Sugden, D. 1992) [ Time Frame: up to 18 weeks ]
  2. Score in Timocco virtual reality system (number of wrong moves; Correct moves;response time) [ Time Frame: up to 18 weeks ]
    data will be gathered using Timocco for the entire intervention


Secondary Outcome Measures :
  1. DCD-Q (BN. Wilson, BJ. Kaplan, SG. Crawford and G. Roberts, 2009) [ Time Frame: up to 18 weeks ]
    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).

  2. Participation questionnaire (Yarus, 2010) [ Time Frame: up to 18 weeks ]
    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).

  3. DTVP-2 (developmental test of visual perception, 1993)) [ Time Frame: Baseline ]
    Screening test.

  4. Satisfaction questionnaire [ Time Frame: up to 18 weeks ]


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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504385


Contacts
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Contact: Ruth Terkel-Dawer, M.D 50-7961922 ext 972 ruthyte@clalit.org.il
Contact: Sarit Tresser, M.Sc 544428294 ext 972 sarit@timocco.com

Sponsors and Collaborators
Clalit Health Services
Timocco Ltd

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Responsible Party: Clalit Health Services
ClinicalTrials.gov Identifier: NCT02504385     History of Changes
Other Study ID Numbers: COM 0024-14
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Motor Skills Disorders
Neurodevelopmental Disorders
Mental Disorders