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临床试验/NCT07321561
NCT07321561已完成不适用

The Effect of Motor Support Program Applıed to Chıldren wıth Autısm Spectrum Dısorder on Gross Motor and Sensory Motor

Istanbul Aydın University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2024年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Change in Motor Skills as Measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition - Short Form (BOT-2 SF)"

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Motor Support Program (Other)

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.

结局指标

主要结局

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

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

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.

Sensory profile questionnaire to assess sensory motor skills

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

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.

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

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

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.

次要结局

未报告次要终点

研究者

发起方
Istanbul Aydın University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gökçe Oktay

Assistant Professor

Istanbul Aydın University

研究点 (1)

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