NCT07321561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 19, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

Autism Spectrum DisorderMotor SkilSensory motor skillMotor Support Program

Outcome Measures

Primary Outcomes (3)

  • Change in Motor Skills as Measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition - Short Form (BOT-2 SF)"

    In this study, the short form of the Bruininks-Oseretsky Motor Competence Test-2 (BOT-2 SF), which was developed to assess the motor skill levels of individuals aged 4-21 years, was used. The short form used in the study consists of a total of eight subtests and 12 items. These subtests include fine motor accuracy, fine motor integration, manual agility, two-way coordination, balance, running speed and agility, hand-arm coordination and strength. The maximum score that can be obtained in the test is 50. As the total score increases, the level of motor skills increases.

    Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).

  • Sensory profile questionnaire to assess sensory motor skills

    The Sensory Profile Scala was designed by Dunn in 1999 to assess children's sensory processing skills and is administered to children aged 3-10 years. The scale aims to assess the sensory reactions of children in their daily lives and is completed by the caregiver. Turkish adaptation, validity and reliability study was conducted by Kayıhan et al. The Sensory Profile Scale consists of three main sections and their sub-sections: (1) Sensory processing, (2) Sensory modulation, and (3) Behavioral-emotional responses. The scale, which consists of 125 items in total, is structured to assess the frequency of children's behaviors in response to different sensory stimuli. The items are scored on a 5-point Likert-type rating system. In this system, "Always" response is evaluated as 1 point and "Never" response is evaluated as 5 points.As the total score on the scale increases, sensory regulation skills improve.

    Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).

  • The Gilliam Autism Rating Scale-2 (GADRS) for the assessment of autism-related symptoms.

    This scale was developed by Gilliam (2006) to diagnose children with autism spectrum disorder. The scale is completed by caregivers. The scale consists of 3 sub-dimensions."0" means never observed while '3' means frequently observed. The scale consists of 42 items. The highest standard score that can be obtained from this scale is 153, and the lowest score is 55. A high total score indicates a high probability of ASD. A low score indicates a low likelihood of ASD. Since the Gilliam Autistic Disorder Rating Scale-2 is a scale that can be used with a certificate, the necessary training and certificate were obtained by the researcher.

    Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).

Study Arms (2)

Motor Support Program

EXPERIMENTAL

The motor support program (MSP) consists of activities prepared by the researchers by taking into account the test protocols used to achieve desired changes in children's gross motor (throwing, jumping, catching, running, etc.), sensory-motor (sensory modulation, sensory processing, sensory inputs related to movement) skill levels and developmental areas.

Other: Motor Support Program

Standard Education (No Motor Support)

NO INTERVENTION

Participants in the control group continued their individual education programs. However, they did not participate in any physiotherapy or motor support programs. Only pre- and post-test measurements were taken.

Interventions

The MSP was administered by the first researcher for 60 minutes, 2 days a week for 12 weeks at the special education center where they were studying. A special program was prepared for the first 10 weeks, and in the last 2 weeks, a choose your activity activity was conducted. During this activity, children were presented with different options consisting of the activities implemented in the first 8 weeks and were asked to choose and implement them. Within each lesson plan, at least 3 different game formats were implemented for children's gross motor skills and sensory motor skills. In the following weeks, different game formats aime

Motor Support Program

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between 4 and 6 years of age
  • Having no health problems that would prevent participation in the study
  • Having been diagnosed with autism according to the Health Board and Guidance and Research Center (RAM) report
  • Not having previously participated in any motor-supported education programs (e.g., occupational therapy sessions)
  • Having no additional diagnoses related to physical or intellectual disabilities other than autism spectrum disorder

You may not qualify if:

  • The participant's failure to attend the training program for three consecutive sessions
  • The participant's failure to fulfill the assigned responsibilities
  • The participant's voluntary withdrawal from the study at any stage for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University

Istanbul, Istanbul, 34320, Turkey (Türkiye)

Location

Related Publications (2)

  • Bruininks RH, & Oseretsky, B. D., 2010, Bruininks-Oseretsky Test Of Motor Proficiency, Second Edition, Brief Form. Bloomington: Psychcorp.

    BACKGROUND
  • Kayıhan H, Günel M. K, Bumin G. Adaptation of the Sensory Profile into Turkish for children aged 3-10 years: A validity and reliability study. Turkish Journal of Physiotherapy and Rehabilitation. 2011; 22(2): 44-53.

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A total of 28 children with ASD participated in the study, 14 students in the experimental group and 14 in the control group. In addition to the special education sessions, the participants in the experimental group received a motor support program for 40 minutes 2 days a week for 12 weeks. In the study, the Gilliam Autistic Disorder Rating Scale-2-TV, the Bruininks-Oseretsky Motor Competence 2 Test Short Form (BOT-2) for the assessment of gross motor skills, and the caregiver sensory profile questionnaire for the assessment of sensory-motor skills were used.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 7, 2026

Study Start

January 5, 2024

Primary Completion

May 10, 2024

Study Completion

June 5, 2024

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations