- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07859345
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 (VR-FAD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beyza Asli BİLSEL, Assistant Professor
- Phone Number: +90 534 310 86 86
- Email: beyza.bilsel@atlas.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Leap Motion-Based Virtual Reality Intervention
Participants will receive a structured Leap Motion-based virtual reality intervention designed to support fine motor skills and functional performance. |
Participants will receive structured, task-oriented virtual reality activities using Leap Motion technology to practice hand and finger movements and support fine motor performance. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline and immediately after completion of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occupational Performance and Satisfaction
Time Frame: At baseline and immediately after completion of the intervention.
|
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. |
At baseline and immediately after completion of the intervention.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Falivene 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.
- Abdel 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.
- Mohd 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATLAS-2026-09-30-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.