Fine Motor SkillsVR-FADNCT07859345
Effects of Virtual Reality-Based Interventions on Fine Motor and Activities of Daily Living Skills in Children Aged 5-10 Years With Autism Spectrum Disorder
A study testing Leap Motion-Based Virtual Reality Intervention in people with Fine Motor Skills and Occupational Performance, run by Beyza Asli Bilsel.
Trial summary
This study will investigate the effects of a Leap Motion-based virtual reality intervention on fine motor skills and daily living performance in children aged 5-10 years with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Fine Motor Skills, Occupational Performance, Virtual Reality (VR) Technology
- What is being tested?
- Leap Motion-Based Virtual Reality Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 27 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5-10 years. A diagnosis of autism spectrum disorder (ASD). Currently receiving occupational therapy services at the study setting. Ability to follow simple verbal instructions and participate in structured intervention activities.
- Ability to use the Leap Motion-based virtual reality system with appropriate assistance if needed.
- Written informed consent obtained from a parent or legal guardian.
Who cannot join
- Presence of a neurological, orthopedic, or other medical condition that significantly affects upper-extremity motor performance.
- Severe visual or hearing impairment that prevents participation in the intervention.
- Significant behavioral difficulties that prevent completion of the assessment or intervention sessions.
- Previous experience with the same Leap Motion-based virtual reality intervention, if applicable.
- Failure to complete the required assessment or intervention sessions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study will investigate the effects of a Leap Motion-based virtual reality intervention on fine motor skills and daily living performance in children aged 5-10 years with autism spectrum disorder (ASD). Children with ASD may experience difficulties in motor coordination, hand use, attention, and daily activities, which may affect their participation in everyday life.
The study will include children with ASD who attend occupational therapy sessions and meet the study eligibility criteria. Participants will receive a structured virtual reality-based intervention using Leap Motion technology. The intervention will provide controlled, repetitive, and task-oriented activities involving hand and finger movements.
Read more
Fine motor skills, daily living performance, and cognitive functioning will be assessed before and after the intervention using standardized assessment tools, including the Nine Hole Peg Test, the Canadian Occupational Performance Measure, and the Mini-Mental State Examination. Changes in fine motor performance and daily living performance from before to after the intervention will be examined.
The study aims to determine whether a Leap Motion-based virtual reality intervention may support fine motor skills and functional performance in children with ASD.
Read the detailed description
Recent research has increasingly explored the use of virtual reality (VR) and technology-assisted approaches to support motor performance and functional abilities in children with autism spectrum disorder (ASD). Technology-based interventions can provide structured, repetitive, and predictable task environments, which may facilitate practice and allow performance to be monitored under standardized conditions.
Leap Motion is a contact-free motion capture technology that detects three-dimensional hand and finger movements using infrared sensors. Its ability to capture parameters such as movement speed, accuracy, and coordination provides an opportunity to deliver interactive tasks involving targeted hand and finger movements. The contact-free nature of the technology may also be useful for children who experience sensory sensitivities or difficulties tolerating physical equipment during therapeutic activities.
Previous studies suggest that technology-assisted interventions may provide advantages such as immediate visual feedback, repeated task practice, adjustable task difficulty, and opportunities for performance-based progression. These characteristics may support engagement and motor learning while allowing activities to be adapted to individual performance levels.
Although VR-based approaches have been increasingly investigated in pediatric rehabilitation, further research is needed to clarify their effects on fine motor performance and functional daily living outcomes in children with ASD. In particular, examining Leap Motion-based applications may provide additional information about the potential of contact-free hand-tracking technology as an approach for supporting fine motor performance and functional abilities.
Therefore, this study will investigate the effects of a Leap Motion-based VR intervention on fine motor skills and daily living performance in children aged 5-10 years with ASD. Changes in selected motor and functional outcomes before and after the intervention will be examined.
- Conditions
- Fine Motor Skills, Occupational Performance, Virtual Reality (VR) Technology, Autism Spectrum Disorder
- Being tested
- Leap Motion-Based Virtual Reality Intervention
- Keywords
- Daily Living Activities, Autism Spectrum Disorder, Fine Motor Skills, Virtual Reality
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leap Motion-Based Virtual Reality InterventionBehavioural
Participants will receive structured, task-oriented virtual reality activities using Leap Motion technology to practice hand and finger movements and support fine motor performance.
| Study group | Role | What they receive |
|---|---|---|
| Leap Motion-Based Virtual Reality Intervention | Experimental | Participants will receive a structured Leap Motion-based virtual reality intervention designed to support fine motor skills and functional performance. Receives: Behavioral: Leap Motion-Based Virtual Reality Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fine Motor Performance
Fine motor performance will be assessed using the Nine Hole Peg Test (NHPT). The test measures the time required to place and remove nine pegs, with shorter completion times indicating better fine motor performance.
Measured: Baseline and immediately after completion of the intervention
Secondary outcomes (1)
Occupational Performance and Satisfaction
Occupational performance and satisfaction will be assessed using the Canadian Occupational Performance Measure (COPM). Participants and their caregivers will identify occupational problems that are important in daily life, and performance and satisfaction with these activities will be rated. Higher scores indicate better self-perceived occupational performance and satisfaction.
Measured: At baseline and immediately after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion27 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fine Motor SkillsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of children with autism spectrum disorder will receive the Leap Motion-based virtual reality intervention. Fine motor skills and daily living performance will be assessed before and after the intervention to examine changes following the intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beyza Asli Bilsel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beyza Asli Bilsel, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859345
- Sponsor's protocol ID
- ATLAS-2026-09-30-01
- Acronym
- VR-FAD
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Talkar T, Williamson JR, Hannon D, Rao HM, Yuditskaya S, Claypool K, Sturim D, Nowinski L, Saro H, Stamm C, Mody M, McDougle CJ, Quatieri TF. Assessment of speech and fine motor coordination in children with autism spectrum disorder. IEEE Access. 2020;8:127535-127545. doi: 10.1109/ACCESS.2020.3007348. Epub 2020 Jul 10.
PubMed 33747676Falivene A, Scaccabarozzi G, Busti Ceccarelli S, Molteni M, Klingels K, Verbecque E, Storm FA, Biffi E, Crippa A. Virtual Reality-Based Postural Balance Training in Autistic Children: A Pilot Randomized Controlled Trial. J Clin Med. 2025 Aug 8;14(16):5616. doi: 10.3390/jcm14165616.
PubMed 40869441Abdel Ghafar MA, Abdelraouf OR, Harraz EM, Seyam MK, Morsy WE, Amin WM, Abd-Elfattah HM. Virtual Reality Rehabilitation Helps to Improve Postural Balance in Children with Autism Spectrum Disorder: A Randomized Control Trial. Phys Occup Ther Pediatr. 2025;45(4):423-436. doi: 10.1080/01942638.2025.2466555. Epub 2025 Mar 6.
PubMed 40051021Mohd Nordin A, Ismail J, Kamal Nor N. Motor Development in Children With Autism Spectrum Disorder. Front Pediatr. 2021 Sep 15;9:598276. doi: 10.3389/fped.2021.598276. eCollection 2021.
PubMed 34604128
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality-Based Interventions on Fine Motor and Activities of Daily Living Skills in Children Aged 5-10 Years With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07859345
- Acronym / sponsor ID
- VR-FAD / ATLAS-2026-09-30-01
- Conditions
- Fine Motor Skills, Occupational Performance, Virtual Reality (VR) Technology, Autism Spectrum Disorder
- Keywords
- Daily Living Activities, Autism Spectrum Disorder, Fine Motor Skills, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beyza Asli BilselUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 27 Apr 2027 (estimated)
- First posted
- 5 Oct 2026 (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.
This study will investigate the effects of a Leap Motion-based virtual reality intervention on fine motor skills and daily living performance in children aged 5-10 years with autism spectrum disorder (ASD). Children with ASD may experience difficulties in motor coordination, hand use, attention, and daily activities, which may affect their participation in everyday life.
The study will include children with ASD who attend occupational therapy sessions and meet the study eligibility criteria. Participants will receive a structured virtual reality-based intervention using Leap Motion technology. The intervention will provide controlled, repetitive, and task-oriented activities involving hand and finger movements.
Fine motor skills, daily living performance, and cognitive functioning will be assessed before and after the intervention using standardized assessment tools, including the Nine Hole Peg Test, the Canadian Occupational Performance Measure, and the Mini-Mental State Examination. Changes in fine motor performance and daily living performance from before to after the intervention will be examined.
The study aims to determine whether a Leap Motion-based virtual reality intervention may support fine motor skills and functional performance in children with ASD.
Detailed description
Recent research has increasingly explored the use of virtual reality (VR) and technology-assisted approaches to support motor performance and functional abilities in children with autism spectrum disorder (ASD). Technology-based interventions can provide structured, repetitive, and predictable task environments, which may facilitate practice and allow performance to be monitored under standardized conditions.
Leap Motion is a contact-free motion capture technology that detects three-dimensional hand and finger movements using infrared sensors. Its ability to capture parameters such as movement speed, accuracy, and coordination provides an opportunity to deliver interactive tasks involving targeted hand and finger movements. The contact-free nature of the technology may also be useful for children who experience sensory sensitivities or difficulties tolerating physical equipment during therapeutic activities.
Previous studies suggest that technology-assisted interventions may provide advantages such as immediate visual feedback, repeated task practice, adjustable task difficulty, and opportunities for performance-based progression. These characteristics may support engagement and motor learning while allowing activities to be adapted to individual performance levels.
Although VR-based approaches have been increasingly investigated in pediatric rehabilitation, further research is needed to clarify their effects on fine motor performance and functional daily living outcomes in children with ASD. In particular, examining Leap Motion-based applications may provide additional information about the potential of contact-free hand-tracking technology as an approach for supporting fine motor performance and functional abilities.
Therefore, this study will investigate the effects of a Leap Motion-based VR intervention on fine motor skills and daily living performance in children aged 5-10 years with ASD. Changes in selected motor and functional outcomes before and after the intervention will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of children with autism spectrum disorder will receive the Leap Motion-based virtual reality intervention. Fine motor skills and daily living performance will be assessed before and after the intervention to examine changes following the intervention.
| Arm | Type | Receives |
|---|---|---|
| Leap Motion-Based Virtual Reality Intervention | Experimental | Behavioral: Leap Motion-Based Virtual Reality InterventionParticipants will receive a structured Leap Motion-based virtual reality intervention designed to support fine motor skills and functional performance. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 5-10 years. A diagnosis of autism spectrum disorder (ASD). Currently receiving occupational therapy services at the study setting. Ability to follow simple verbal instructions and participate in structured intervention activities.
- Ability to use the Leap Motion-based virtual reality system with appropriate assistance if needed.
- Written informed consent obtained from a parent or legal guardian.
Key exclusion criteria (5 listed)
- Presence of a neurological, orthopedic, or other medical condition that significantly affects upper-extremity motor performance.
- Severe visual or hearing impairment that prevents participation in the intervention.
- Significant behavioral difficulties that prevent completion of the assessment or intervention sessions.
- Previous experience with the same Leap Motion-based virtual reality intervention, if applicable.
- Failure to complete the required assessment or intervention sessions.
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 |
|---|---|---|
| Leap Motion-Based Virtual Reality InterventionParticipants will receive structured, task-oriented virtual reality activities using Leap Motion technology to practice hand and finger movements and support fine motor performance. | Behavioural | Leap Motion-Based Virtual Reality Intervention |
Primary outcome
Fine Motor Performance
Time frame: Baseline and immediately after completion of the intervention
Fine motor performance will be assessed using the Nine Hole Peg Test (NHPT). The test measures the time required to place and remove nine pegs, with shorter completion times indicating better fine motor performance.
1 secondary outcome
Occupational Performance and Satisfaction
Time frame: At baseline and immediately after completion of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 33747676Talkar T, Williamson JR, Hannon D, Rao HM, Yuditskaya S, Claypool K, Sturim D, Nowinski L, Saro H, Stamm C, Mody M, McDougle CJ, Quatieri TF. Assessment of speech and fine motor coordination in children with autism spectrum disorder. IEEE Access. 2020;8:127535-127545. doi: 10.1109/ACCESS.2020.3007348. Epub 2020 Jul 10.
- Background: PubMed 40869441Falivene A, Scaccabarozzi G, Busti Ceccarelli S, Molteni M, Klingels K, Verbecque E, Storm FA, Biffi E, Crippa A. Virtual Reality-Based Postural Balance Training in Autistic Children: A Pilot Randomized Controlled Trial. J Clin Med. 2025 Aug 8;14(16):5616. doi: 10.3390/jcm14165616.
- Background: PubMed 40051021Abdel Ghafar MA, Abdelraouf OR, Harraz EM, Seyam MK, Morsy WE, Amin WM, Abd-Elfattah HM. Virtual Reality Rehabilitation Helps to Improve Postural Balance in Children with Autism Spectrum Disorder: A Randomized Control Trial. Phys Occup Ther Pediatr. 2025;45(4):423-436. doi: 10.1080/01942638.2025.2466555. Epub 2025 Mar 6.
- Background: PubMed 34604128Mohd Nordin A, Ismail J, Kamal Nor N. Motor Development in Children With Autism Spectrum Disorder. Front Pediatr. 2021 Sep 15;9:598276. doi: 10.3389/fped.2021.598276. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Leap Motion-Based Virtual Reality Intervention in people with Fine Motor Skills and Occupational Performance, run by Beyza Asli Bilsel.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beyza Asli BİLSEL, Assistant Professor (+90 534 310 86 86, beyza.bilsel@atlas.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fine Motor Performance (time frame: Baseline and immediately after completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07859345, which also lists 4 linked publications.
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 Oct 2026.