Effects of VR in Children With DCD: Randomized Controlled Trial

Virtual Reality Clinical Trial

Official title:

Effects of Virtual Reality in Children With Developmental Coordination Disorder: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06246318
• Other study ID #: VR24
• Status: Completed
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: April 2, 2024

Study information

• Verified date: April 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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. 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. H0: VR application has no effect on sensory-perception skills in children with DCD.

H1: VR application has an effect on sensory-perception skills in children with DCD.

4. H0: VR application has no effect on the functional independence levels in daily living activities in children with DCD.

H1: VR application has an effect on the functional independence levels in daily living activities in children with DCD.

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.

Description:

Within the scope of our aims;

• To determine the gross motor skill levels of children with DCD and to obtain the effect of VR application on gross motor skill levels.

• To determine the executive function skill levels of children with DCD and to obtain the effect of VR application on executive function skill levels.

• To determine the sensory-perception skill levels of children with DCD and to obtain the effect of VR application on sensory-perception skill levels.

• To determine the functional independence of children with DCD in daily life and to obtain the effect of VR application on their functional independence levels.

• It is aimed to determine the participation levels of children with DCD and to obtain the effect of VR application on their participation levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Developmental Coordination Disorder
• Executive Dysfunction
• Motor Skills Disorders
• Participation, Patient
• Sensation Disorders
• Sensory Disorder
• Virtual Reality

Intervention

Other:
• virtual reality
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.
• 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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Sihhiye

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Sensory Integration 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.
Primary	Motor-Free Visual Perception Test-3	Assessment of visual perception	It will be applied 8 weeks after the first evaluations are made.
Secondary	Participation and Environment Measure for Children and Youth (PEM-CY)	The PEM-CY is a measure that evaluates participation in the home, at school, and in the community, alongside environmental factors within each of these settings.	It will be applied 8 weeks after the first evaluations are made.
Secondary	CHILDHOOD EXECUTIVE FUNCTIONING INVENTORY (CHEXI) FOR PARENTS AND TEACHERS	Working memory and inhibitory control levels will be evaluated with CHEXI.	It will be applied 8 weeks after the first evaluations are made.
Secondary	Functional Independence Measure for Children (WeeFIM)	functional independence was assessed with the Functional Independence Measure for Children (WeeFIM).	It will be applied 8 weeks after the first evaluations are made.