- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02504385
The Effect of Virtual Reality on Motor Functioning and Participation Abilities Among Children With DCD
The Effect of Timocco's Virtual Reality Environment on the Motor Functioning and Participation Abilities Among Children With DCD
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ruth Terkel-Dawer, M.D
- Phone Number: 972 50-7961922
- Email: ruthyte@clalit.org.il
Study Contact Backup
- Name: Sarit Tresser, M.Sc
- Phone Number: 972 544428294
- Email: sarit@timocco.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
|
Traditional Occupational Therapy intervention will be givven to the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The score in Motor and participation assessments (Henderson, S. & Sugden, D. 1992)
Time Frame: up to 18 weeks
|
up to 18 weeks
|
|
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
|
up to 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
up to 18 weeks
|
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).
|
up to 18 weeks
|
DTVP-2 (developmental test of visual perception, 1993))
Time Frame: Baseline
|
Screening test.
|
Baseline
|
Satisfaction questionnaire
Time Frame: up to 18 weeks
|
up to 18 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COM 0024-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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