- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Beyza Asli BİLSEL, Assistant Professor
- Numer telefonu: +90 534 310 86 86
- E-mail: beyza.bilsel@atlas.edu.tr
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Fine Motor Performance
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Occupational Performance and Satisfaction
Ramy czasowe: 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.
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ATLAS-2026-09-30-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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