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

Developmental Coordination Disorder Clinical Trial

Official title:

The Effect of Timocco's Virtual Reality Environment on the Motor Functioning and Participation Abilities Among Children With DCD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02504385
• Other study ID #: COM 0024-14
• Status: Not yet recruiting
• Phase: N/A
• First received: March 29, 2015
• Last updated: July 20, 2015
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: Clalit Health Services
• Contact: Ruth Terkel-Dawer, M.D
• Phone: 50-7961922
• Email: ruthyte[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 4 Years to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Developmental Coordination Disorder
• Motor Skills Disorders

Intervention

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.

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Clalit Health Services	Timocco Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The score in Motor and participation assessments (Henderson, S. & Sugden, D. 1992)		up to 18 weeks	No
Primary	Score in Timocco virtual reality system (number of wrong moves; Correct moves;response time)	data will be gathered using Timocco for the entire intervention	up to 18 weeks	No
Secondary	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).	up to 18 weeks	No
Secondary	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).	up to 18 weeks	No
Secondary	DTVP-2 (developmental test of visual perception, 1993))	Screening test.	Baseline	No
Secondary	Satisfaction questionnaire		up to 18 weeks	No