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IRCT20250720066558N1 IRCT 2025-08-15 Ahvaz University of Medical Sciences Investigating the Effect of Sensorimotor Exercises on Repetitive Behaviors in Children with Autism Evaluation of the effect of sensory integration approach on stereotyped behaviors of children with autism spectrum disorder 2025-11-16 anticipated 60 Complete https://irct.ir/trial/85207 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To allocate 60 participants into two groups of 30 each, a randomization method using blocks of 4 was employed. In this method, each block consisted of 4 individuals, evenly divided between the two groups (two participants in the intervention group and two in the control group). First, all possible combinations of this type of allocation (such as AABB, ABAB, ABBA, etc.) were entered into Excel software. Then, 15 blocks were randomly selected from these combinations so that a total of 60 participants were evenly and randomly assigned to the two groups. To generate random combinations, the Rand Between and Index functions in Excel were used, determining each individual's placement in the intervention or control group. Finally, the results were manually saved to ensure no changes occurred in the allocation after determination. N/A Autism Spectrum Disorder. Intervention 1: Intervention group: The intervention is conducted over 11 consecutive weeks, with 11 sessions using tools such as a soft brush, massager, and ball pool, each session lasting 45 minutes. Sessions are held twice a week by the occupational therapist of the education center under the supervision of the principal investigator. After 11 sessions, the severity of stereotyped behaviors in both groups is reassessed using the GARS tool. The effectiveness of this intervention is evaluated by analyzing the final questionnaire results. Intervention 2: Control group: The control group participants will not receive any sensory integration intervention during the study period and will only receive the usual educational and rehabilitation services and programs of the center. After the completion of the study, if they wish, the sensory integration intervention will also be provided to this group. Yes - There is a plan to make this available What will be shared: De-identified individual participant data, including results for the primary outcome measure (GARS questionnaire scores), will be available upon reasonable request from qualified researchers after completion of data analysis. Other raw data will be shared only in aggregate form without any possibility of identifying participants. When: Access to de-identified individual participant data will be available starting 6 months after publication of the study results and will remain open for 3 years. Access will be granted only to qualified researchers upon submission of a reasonable request and approval by the principal investigator To whom: Data and study documents will be available only to qualified researchers affiliated with accredited academic institutions or recognized research centers, upon submission of a written request and approval by the principal investigator Conditions: Access to anonymized data and study documents will be granted only to researchers affiliated with academic and scientific institutions. Requestors must submit a formal application describing the intended analyses. Use of the data and documents is limited to approved research purposes, and any further sharing or publication requires prior permission from the study’s principal investigator. Compliance with ethical guidelines and confidentiality agreements is mandatory Where to obtain: Applicants requesting study documents or data can submit their written requests via email to the principal investigator. If postal correspondence is required, they may contact the following postal address at Jundishapur University of Medical Sciences, Ahvaz. Contact details are as follows: Contact Person: Dr. Hossein Kemili Sani Email: hossein.kemili@ajums.ac.ir Postal Address: Golestan Street, Jundishapur University of Medical Sciences, Ahvaz, Postal Code 61357-14551, Iran Phone Number: +98 61 3333 1234 Fax Number: +98 61 3333 5678 Priority for receiving requests is via email, and if official documents or formal correspondence are needed, they will be handled through the postal address. How to obtain: Applicants must submit a written request via email or postal mail to the study coordinator. Upon receipt, the request will undergo an initial review by the research team to ensure completeness and validity. Then, the request will be forwarded to the ethics committee and relevant authorities for approval. This process typically takes 2 to 4 weeks. Once approved, de-identified documents or data files will be sent to the applicant electronically. If printed copies or official documents are required, additional time will be needed depending on the delivery method Comments:
public Marzie Zakernejad
No. 17, Nazem Street, Shariati Neighborhood, by the river
Ahvaz Iran (Islamic Republic of) 6197870008 +98 61 3550 7191 marzie.zakernejad@gmail.com Ahvaz University of Medical Sciences scientific Marzie Zakernejad
No. 17, Nazem Street, Shariati Neighborhood, by the river
Ahvaz Iran (Islamic Republic of) 6197870008 +98 61 3550 7191 marzie.zakernejad@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of autism spectrum disorder with mild to moderate severity Enrollment in exceptional education centers for children with autism spectrum disorder in Ahvaz Willingness and consent of the parents of these individuals to participate in the study Regular use of Risperidone and Ritalin medications according to parents’ report 4 years 10 years Both Concurrent diagnosis of severe psychiatric disorders such as psychosis, severe bipolar disorder, personality disorder, or uncontrolled epilepsy Diagnosis of blindness or deafness F84.0 Autistic disorder Rehabilitation Rehabilitation Intervention group: The intervention is conducted over 11 consecutive weeks, with 11 sessions using tools such as a soft brush, massager, and ball pool, each session lasting 45 minutes. Sessions are held twice a week by the occupational therapist of the education center under the supervision of the principal investigator. After 11 sessions, the severity of stereotyped behaviors in both groups is reassessed using the GARS tool. The effectiveness of this intervention is evaluated by analyzing the final questionnaire results. Control group: The control group participants will not receive any sensory integration intervention during the study period and will only receive the usual educational and rehabilitation services and programs of the center. After the completion of the study, if they wish, the sensory integration intervention will also be provided to this group. Change in the severity of stereotyped behaviors in children with autism spectrum disorder based on the GARS questionnaire score. Timepoint: Before and after the intervention (after 11 sessions of the sensory integration approach). Method of measurement: Gilliam Autism Rating Scale (GARS). Ahvaz University of Medical Sciences Approved 2025-07-15 Ethics Committee of Jundishapur University of Medical Sciences No. 17, Nazem Street, Shariati Street End, Jomhouri Alley اهواز Khouzestan Iran (Islamic Republic of)