- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07789704
Structured Sensory-Based Occupational Therapy in Children With Autism
Effects of Structured Sensory-Based Occupational Therapy on Occupational Performance and Sensory-Motor Outcomes in Children With Autism Spectrum Disorder: A Controlled Clinical Study
연구 개요
상태
정황
상세 설명
This controlled clinical study will evaluate the effects of a structured sensory-based occupational therapy intervention on occupational performance, sensory processing, gross motor development, and eating behaviors in children with autism spectrum disorder.
A total of 40 children aged 3-9 years with Level 2 autism spectrum disorder will be assigned to a structured sensory-based occupational therapy group (n=20) or a control group (n=20). The intervention group will receive 40-minute, face-to-face occupational therapy sessions twice weekly for 12 weeks. The sessions will be structured according to each child's sensory and functional needs and will be progressively adapted based on the child's clinical development. The control group will receive individualized home recommendations, which will be monitored weekly using information and visual records provided by caregivers.
Assessments will be performed at baseline and after 12 weeks. Occupational performance and satisfaction will be evaluated using the Canadian Occupational Performance Measure, sensory processing using the Dunn Sensory Profile, gross motor development using the Test of Gross Motor Development-Third Edition, and eating behaviors using the Children's Eating Behaviour Questionnaire.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Emre Dansuk, PhD
- 전화번호: 05377790434
- 이메일: edansuk@medipol.edu.tr
연구 연락처 백업
- 이름: Burak Menek, PhD
연구 장소
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Beykoz
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Istanbul, Beykoz, 터키 (Türkiye), 34815
- 모병
- Emre Dansuk
-
연락하다:
- Emre Dansuk, PhD
- 전화번호: 05377790434
- 이메일: edansuk@medipol.edu.tr
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children aged 3-9 years
- Diagnosis of autism spectrum disorder according to DSM-5 criteria
- Level 2 autism spectrum disorder
- Residence in Istanbul
- Written informed consent provided by a parent or legal guardian
Exclusion Criteria:
- Presence of an additional neurological, psychiatric, genetic, or developmental diagnosis
- Regular medication use that may affect study outcomes
- History of epilepsy or seizures
- Inability to participate in the assessment or intervention procedures
- Participation in another structured sensory-based occupational therapy program during the study period
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Structured Sensory-Based Occupational Therapy Group
Participants in this group will receive 40-minute, face-to-face structured sensory-based occupational therapy sessions twice weekly for 12 weeks.
The intervention will be individualized according to each child's sensory and functional needs and will include tactile, proprioceptive, vestibular, visual-motor, gross motor, feeding-related, and occupational performance activities.
Session content will be progressively adapted according to the child's development.
Caregivers will also receive brief recommendations for home practice.
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The intervention will consist of individualized sensory-based occupational therapy activities addressing tactile, proprioceptive, vestibular, visual-motor, gross motor, feeding-related, and occupational performance needs.
It will be delivered face-to-face for 40 minutes, twice weekly, over 12 weeks, and will be progressively adapted according to each child's clinical needs and development.
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활성 비교기: Home Program Control Group
Participants in this group will receive individualized home-based activity recommendations using materials available in the home environment.
The home program will be implemented for 12 weeks and will be monitored weekly for approximately 10 minutes using verbal information and visual records provided by caregivers.
Participants will not receive face-to-face structured sensory-based occupational therapy during the study period.
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Caregivers will implement individualized home-based sensory and functional activity recommendations using materials available in the home environment.
The program will continue for 12 weeks and adherence will be monitored weekly through caregiver reports and visual records.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Occupational Performance
기간: Baseline and Week 12
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Occupational performance will be assessed using the performance score of the Canadian Occupational Performance Measure.
Higher scores will indicate better perceived occupational performance.
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Baseline and Week 12
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Change in Satisfaction with Occupational Performance
기간: Baseline and Week 12
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Satisfaction with occupational performance will be assessed using the satisfaction score of the Canadian Occupational Performance Measure.
Higher scores will indicate greater satisfaction.
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Baseline and Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Sensory Processing
기간: Baseline and Week 12
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Sensory processing will be assessed using the Dunn Sensory Profile.
Scale scores will be interpreted according to the instrument's standardized scoring system.
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Baseline and Week 12
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Change in Gross Motor Development
기간: Baseline and Week 12
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Gross motor development will be assessed using the Test of Gross Motor Development Third Edition, including locomotor and ball skills subscales.
Higher scores will indicate better gross motor performance.
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Baseline and Week 12
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Change in Eating Behaviors
기간: Baseline and Week 12
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Eating behaviors will be assessed using the Children's Eating Behaviour Questionnaire and its subscale scores.
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Baseline and Week 12
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Emre DANSUK, PhD, Medipol University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- E-10840098-202.3.02-4787
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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