NCT06246318

Brief Summary

The aim of the study is to examine the effect of VR application on motor, cognitive and sensory-perceptual skills, and activity and participation levels in children with DCD. The hypotheses on which the study proposal is based are as follows:

  1. 1.H0: VR application has no effect on motor skills in children with DCD. H1: VR application has an effect on motor skills in children with DCD.
  2. 2.H0: VR application has no effect on cognitive skills in children with DCD. H1: VR application has an effect on cognitive skills in children with DCD.
  3. 3.H0: VR application has no effect on sensory-perception skills in children with DCD.
  4. 4.H0: VR application has no effect on the functional independence levels in daily living activities in children with DCD.
  5. 5.H0: VR application has no effect on participation levels in children with DCD. H1: VR application has an effect on participation levels in children with DCD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 17, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

January 25, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

January 17, 2024

Last Update Submit

April 4, 2024

Conditions

Keywords

virtual realityVisual Perceptualmotor skillsDevelopmental Coordination Disordersensory perceptioncognitionparticipation

Outcome Measures

Primary Outcomes (3)

  • Test of Gross Motor Development-2

    Assessment of gross and fine motor skills

    It will be applied 8 weeks after the first evaluations are made.

  • Sensory İntegration and praxis test

    It is a standardized test developed by Ayres that evaluates in detail sensory perception and sensory perception-related skills in children between the ages of 4 and 8 years and 11 months. SIPT consists of a total of 17 subtests.

    It will be applied 8 weeks after the first evaluations are made.

  • Motor-Free Visual Perception Test-3

    Assessment of visual perception

    It will be applied 8 weeks after the first evaluations are made.

Secondary Outcomes (3)

  • Participation and Environment Measure for Children and Youth (PEM-CY)

    It will be applied 8 weeks after the first evaluations are made.

  • CHILDHOOD EXECUTIVE FUNCTIONING INVENTORY (CHEXI) FOR PARENTS AND TEACHERS

    It will be applied 8 weeks after the first evaluations are made.

  • Functional Independence Measure for Children (WeeFIM)

    It will be applied 8 weeks after the first evaluations are made.

Study Arms (2)

virtual reality plus conventional occupational therapy

EXPERIMENTAL

Virtual reality will be given to the study group in addition to the conventional occupational therapy program. Nintendo Wii Fit Plus will be used as the virtual reality method in the research.

Other: virtual realityOther: conventional occupational therapy

conventional occupational therapy

OTHER

This is a control group. Sensory integration and gross motor training approaches are used in the conventional occupational therapy program.

Other: conventional occupational therapy

Interventions

The virtual reality protocol here is based on perceptual-motor activities, supported by Nintendo Wii resources. The user will be able to control a game character in a virtual environment using a remote control with a motion sensor. Wii Fit Plus requires the use of the Wii Balance Board that the player stands on during gameplay. The Wii Balance Board is not a wobbly balance board, but is able to detect and track the user's center of balance, a feature used extensively in the game. Wii Fit Plus includes more than 40 activities including yoga, strength training, aerobics and balance games. During the virtual reality application, different games will be preferred in each session depending on the duration of the games. Virtual reality application will be carried out in a corner prepared for virtual reality application in the room where the conventional occupational therapy session is held. Families have the right to observe and attend all sessions whenever they wish.

virtual reality plus conventional occupational therapy

Sensory integration and gross motor training approaches will be used in the conventional occupational therapy program. A manualized protocol based on Ayres sensory integration principles will be followed (Schaaf et al., 2012). The intervention will be carried out by a licensed occupational therapist trained in sensory integration. This approach suggests that if a child engages in individually adapted sensorimotor activities, the nervous system is better able to modulate, organize, and integrate sensory information and is also more likely to use sensory information in adaptive ways (Ayres, 1972). Components of the intervention include a sensory-rich, playful, child-centered approach, providing a decision challenge, and facilitating increasingly complex adaptive behaviors by engaging the child in individually tailored, developmentally appropriate play interactions

conventional occupational therapyvirtual reality plus conventional occupational therapy

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between 5-8 years old,
  • It is to get 15-46 points from the Developmental Coordination Disorder Questionnaire for ages 5-7 and 15-55 points for ages 8.

You may not qualify if:

  • Those who are receiving any other therapy program,
  • have vision (other than glasses) or hearing problems,
  • Children with any neurological disorder will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Skills DisordersSensation DisordersPatient Participation

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • zeynep kolit, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Sedef şahin, PhD

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 7, 2024

Study Start

January 25, 2024

Primary Completion

March 30, 2024

Study Completion

April 2, 2024

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations