Structured Sensory-Based Occupational Therapy in Children With Autism
2026年9月7日 更新者：Emre DANSUK
Effects of Structured Sensory-Based Occupational Therapy on Occupational Performance and Sensory-Motor Outcomes in Children With Autism Spectrum Disorder: A Controlled Clinical Study
This controlled clinical study will investigate the effects of a 12-week structured sensory-based occupational therapy intervention on occupational performance, sensory processing, gross motor development, and eating behaviors in children with autism spectrum disorder.
Forty children aged 3-9 years will be assigned to either an intervention group receiving face-to-face occupational therapy twice weekly or a control group receiving an individualized home program.
調査の概要
状態
募集
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Emre Dansuk, PhD
- 電話番号：05377790434
- メール：edansuk@medipol.edu.tr
研究連絡先のバックアップ
- 名前：Burak Menek, PhD
研究場所
-
-
Beykoz
-
Istanbul、Beykoz、トルコ（Türkiye）、34815
- 募集
- Emre Dansuk
-
コンタクト：
- Emre Dansuk, PhD
- 電話番号：05377790434
- メール：edansuk@medipol.edu.tr
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Occupational Performance
時間枠：Baseline and Week 12
|
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
時間枠：Baseline and Week 12
|
Satisfaction with occupational performance will be assessed using the satisfaction score of the Canadian Occupational Performance Measure.
Higher scores will indicate greater satisfaction.
|
Baseline and Week 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Sensory Processing
時間枠：Baseline and Week 12
|
Sensory processing will be assessed using the Dunn Sensory Profile.
Scale scores will be interpreted according to the instrument's standardized scoring system.
|
Baseline and Week 12
|
|
Change in Gross Motor Development
時間枠：Baseline and Week 12
|
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.
|
Baseline and Week 12
|
|
Change in Eating Behaviors
時間枠：Baseline and Week 12
|
Eating behaviors will be assessed using the Children's Eating Behaviour Questionnaire and its subscale scores.
|
Baseline and Week 12
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Emre DANSUK, PhD、Medipol University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月28日
一次修了 (推定)
2026年11月1日
研究の完了 (推定)
2026年11月1日
試験登録日
最初に提出
2026年8月24日
QC基準を満たした最初の提出物
2026年8月24日
最初の投稿 (実際)
2026年8月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- E-10840098-202.3.02-4787
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request to the corresponding author for scientifically sound research purposes.
Data access will be subject to approval of the proposed use and completion of an appropriate data-sharing agreement, in accordance with institutional policies and applicable ethical requirements.
IPD 共有時間枠
Beginning immediately after publication and available for five years.
IPD 共有アクセス基準
Data will be made available to qualified researchers who submit a methodologically sound research proposal.
Requests will be reviewed by the corresponding author and will require institutional approval and a signed data-sharing agreement.
Data will be provided solely for the purposes specified in the approved proposal.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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