Effects of VR in Children With DCD: Randomized Controlled Trial
Effects of Virtual Reality in Children With Developmental Coordination Disorder: Randomized Controlled Trial
1 other identifier
interventional
48
1 country
1
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.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.
- 4.H0: VR application has no 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
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
CompletedStudy Start
First participant enrolled
January 25, 2024
CompletedFirst Posted
Study publicly available on registry
February 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2024
CompletedApril 5, 2024
April 1, 2024
2 months
January 17, 2024
April 4, 2024
Conditions
Keywords
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
EXPERIMENTALVirtual 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.
conventional occupational therapy
OTHERThis is a control group. Sensory integration and gross motor training approaches are used in the conventional occupational therapy program.
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.
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
Eligibility Criteria
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
zeynep kolit, MSc
Hacettepe University
- STUDY DIRECTOR
Sedef şahin, PhD
Hacettepe University
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