NCT02504385

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

March 29, 2015

Last Update Submit

July 20, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • The score in Motor and participation assessments (Henderson, S. & Sugden, D. 1992)

    up to 18 weeks

  • 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

Secondary Outcomes (4)

  • DCD-Q (BN. Wilson, BJ. Kaplan, SG. Crawford and G. Roberts, 2009)

    up to 18 weeks

  • Participation questionnaire (Yarus, 2010)

    up to 18 weeks

  • DTVP-2 (developmental test of visual perception, 1993))

    Baseline

  • Satisfaction questionnaire

    up to 18 weeks

Study Arms (2)

Virtual Reality Timocco

EXPERIMENTAL

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

Conventional OT intervention

ACTIVE COMPARATOR

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

Interventions

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.

Virtual Reality Timocco

Traditional Occupational Therapy intervention will be givven to the control group.

Conventional OT intervention

Eligibility Criteria

Age4 Years - 6 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Central Study Contacts

Ruth Terkel-Dawer, M.D

CONTACT

Sarit Tresser, M.Sc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2015

First Posted

July 21, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

July 21, 2015

Record last verified: 2015-07