Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 5:45 PM
Study NCT ID:
NCT07321561
Status:
COMPLETED
Last Update Posted:
2026-01-07
First Post:
2025-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Motor Support Program in Children With Autism
Sponsor:
Istanbul Aydın University
Organization:
Study Overview
Official Title:
The Effect of Motor Support Program Applıed to Chıldren wıth Autısm Spectrum Dısorder on Gross Motor and Sensory Motor
Status:
COMPLETED
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study examined a motor support program applied for 40 minutes, two days per week, over a period of 12 weeks in children aged 4-6 years diagnosed with autism spectrum disorder. A total of 28 children with autism spectrum disorder participated in the study, including 14 children in the experimental group and 14 children in the control group. In addition to their regular special education sessions, participants in the experimental group received the motor support program for 40 minutes, two days per week, for 12 weeks. Data collection instruments included the Gilliam Autistic Disorder Rating Scale-Second Edition, Turkish Version (GARS-2-TV), the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, Short Form (BOT-2) for the assessment of gross motor skills, and the caregiver-completed Sensory Profile Questionnaire for the assessment of sensory-motor skills.
Detailed Description:
This study is a quasi-experimental research design including pretest-posttest experimental and control groups, and one of the previously determined groups was randomly assigned as the experimental group and the other as the control group. The study was conducted with a total of 28 children, including 14 children in the control group (CG) and 14 children in the experimental group (EG), aged between 4 and 6 years, diagnosed with autism spectrum disorder, who were continuing their education in special education and rehabilitation centers located in the Bayrampaşa and Esenyurt districts of Istanbul. The number of participants was determined using G\*Power analysis, with a statistical power of 0.80, an effect size of 0.05, and a margin of error of 0.05. The inclusion criteria were defined as being between the ages of 4 and 6 years, having a diagnosis of autism spectrum disorder, having no additional intellectual disability, and having no health condition that would prevent participation in physical activity. Data collection instruments included the Gilliam Autistic Disorder Rating Scale-Second Edition, Turkish Version (GARS-2-TV), the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, Short Form (BOT-2) for the assessment of gross motor skills, and the caregiver-completed Sensory Profile Questionnaire for the assessment of sensory-motor skills. The BOT-2 Short Form was administered in approximately 20-25 minutes per child. The GARS-2-TV, administered through interviews with caregivers, was completed in approximately 25-30 minutes per child. The Sensory Profile Questionnaire was completed by caregivers in approximately 30-35 minutes per child. As the GARS-2-TV requires certification for administration, the required training and certification were obtained by the evaluator.The motor support program (MSP) consisted of activities prepared in accordance with test protocols to support children's gross motor skills (e.g., throwing, jumping, catching, running) and sensory-motor skills (e.g., sensory modulation, sensory processing, and movement-related sensory input). The MSP was implemented for 60 minutes per session, two days per week, over a period of 12 weeks at the special education centers attended by the participants. A structured program was applied during the first 10 weeks, and during the final 2 weeks, a "choose-your-activity" approach was implemented, in which children selected activities from those applied during the previous weeks. Within each session, at least three different game-based activity formats targeting gross motor and sensory-motor skills were implemented. In subsequent weeks, different game formats were included to address multiple developmental domains.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: