Virtual RealityNCT06246318
Effects of VR in Children With DCD: Randomized Controlled Trial
A study testing virtual reality and conventional occupational therapy in people with Virtual Reality and Developmental Coordination Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Virtual Reality, Developmental Coordination Disorder, Visual Perceptual Weakness
- What is being tested?
- virtual reality and conventional occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2024to 2 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Virtual Reality in Children With Developmental Coordination Disorder: Randomized Controlled Trial
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:
- 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.
- 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.
- 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.
- 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.
- 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.
Read the detailed 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.
- Conditions
- Virtual Reality, Developmental Coordination Disorder, Visual Perceptual Weakness, Motor Skills Disorders, Sensory Disorder, Executive Dysfunction
- Being tested
- virtual reality, conventional occupational therapy
- Keywords
- virtual reality, Visual Perceptual, motor skills, Developmental Coordination Disorder, sensory perception, cognition, participation
- Medical subject headings
- Motor Skills Disorders, Sensation Disorders, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityOther
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 therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: virtual reality; Other: 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. Receives: Other: conventional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Gross Motor Development-2
Assessment of gross and fine motor skills
Measured: 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.
Measured: It will be applied 8 weeks after the first evaluations are made.
Motor-Free Visual Perception Test-3
Assessment of visual perception
Measured: 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)
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.
Measured: It will be applied 8 weeks after the first evaluations are made.
CHILDHOOD EXECUTIVE FUNCTIONING INVENTORY (CHEXI) FOR PARENTS AND TEACHERS
Working memory and inhibitory control levels will be evaluated with CHEXI.
Measured: It will be applied 8 weeks after the first evaluations are made.
Functional Independence Measure for Children (WeeFIM)
functional independence was assessed with the Functional Independence Measure for Children (WeeFIM).
Measured: It will be applied 8 weeks after the first evaluations are made.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start25 Jan 2024
- Primary completion30 Mar 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZEYNEP KOLİT, Hacettepe University
- Investigators
- zeynep kolit, MSc, Principal investigator, Hacettepe UniversitySedef şahin, PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246318
- Sponsor's protocol ID
- VR24
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality in Children With Developmental Coordination Disorder: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06246318
- Acronym / sponsor ID
- VR24
- Conditions
- Virtual Reality, Developmental Coordination Disorder, Visual Perceptual Weakness, Motor Skills Disorders, Sensory Disorder, Executive Dysfunction
- Keywords
- virtual reality, Visual Perceptual, motor skills, Developmental Coordination Disorder, sensory perception, cognition, participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality plus conventional occupational therapy | Experimental | Other: virtual reality, Other: conventional occupational therapyVirtual 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 | Other | Other: conventional occupational therapyThis is a control group. Sensory integration and gross motor training approaches are used in the conventional occupational therapy program. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual realityThe 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. | Other | virtual reality plus conventional occupational therapy |
| conventional occupational therapySensory 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 | Other | conventional occupational therapy, virtual reality plus conventional occupational therapy |
Primary outcome
Test of Gross Motor Development-2
Time frame: It will be applied 8 weeks after the first evaluations are made.
Assessment of gross and fine motor skills
Sensory İntegration and praxis test
Time frame: It will be applied 8 weeks after the first evaluations are made.
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.
Motor-Free Visual Perception Test-3
Time frame: It will be applied 8 weeks after the first evaluations are made.
Assessment of visual perception
3 secondary outcomes
Participation and Environment Measure for Children and Youth (PEM-CY)
Time frame: It will be applied 8 weeks after the first evaluations are made.
CHILDHOOD EXECUTIVE FUNCTIONING INVENTORY (CHEXI) FOR PARENTS AND TEACHERS
Time frame: It will be applied 8 weeks after the first evaluations are made.
Functional Independence Measure for Children (WeeFIM)
Time frame: It will be applied 8 weeks after the first evaluations are made.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zeynep kolit, MSc principal investigator
Hacettepe University
Sedef şahin, PhD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality and conventional occupational therapy in people with Virtual Reality and Developmental Coordination Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Gross Motor Development-2 (time frame: It will be applied 8 weeks after the first evaluations are made.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.