Sensory-Motor Integration for Sensory Processing and Balance in ASD (SMIE-ASD)

The Effects of Sensory-Motor Integration Exercises on Sensory Processing and Balance in Children With Autism Spectrum Disorder: A Randomized Controlled Trial

This randomized controlled trial evaluates the effectiveness of a 16-week structured sensory-motor integration exercise program compared to conventional therapy (Applied Behavior Analysis and massage therapy) in improving sensory processing abilities and balance in children aged 6-12 years diagnosed with Autism Spectrum Disorder (ASD). Outcomes are measured using the Short Sensory Profile and Berg Balance Scale at baseline and after 16 weeks of intervention. Findings aim to demonstrate the clinical utility of sensory-motor integration exercises in enhancing functional outcomes for children with ASD.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Behavioral: Sensory-Motor Integration Exercises; Behavioral: Conventional therapy group

Detailed Description

Children with Autism Spectrum Disorder often experience significant sensory processing issues and motor coordination challenges, particularly balance deficits. This study evaluates a sensory-motor integration intervention aimed at improving sensory modulation and motor abilities. Participants aged 6 to 12 years are randomized into two groups: an intervention group participating in structured sensory-motor exercises (64 sessions, 4 times weekly, 45 minutes per session), and a control group receiving conventional therapy (primarily Applied Behavior Analysis and massage therapy). Outcomes are assessed using standardized measures: the Short Sensory Profile (SSP) for sensory processing and the Berg Balance Scale (BBS) for balance, at baseline and immediately following the intervention period.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Faculty of Sport Sciences, Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 6-12 years
• Diagnosed with Autism Spectrum Disorder (DSM-5 criteria)
• Mild-to-moderate ASD severity (CARS score ≤ 39.5)
• Ability to participate in structured sessions

Exclusion Criteria:

• Significant physical impairments or medical conditions affecting participation
• Recent (within 6 months) participation in sensory integration therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants received structured sensory-motor integration exercises, consisting of sensory play activities tailored to enhance sensory processing and balance. Sessions lasted 45 minutes each, conducted 4 times weekly for 16 weeks (64 total sessions).	Behavioral: Sensory-Motor Integration Exercises; A structured sensory-motor integration program based on sensory play activities designed to enhance sensory processing and balance. Each session lasted 45 minutes, conducted four times per week, for a total of 64 sessions over 16 weeks. Activities targeted multiple sensory modalities, including tactile, proprioceptive, and vestibular inputs.
Active Comparator: Control group; Participants received conventional therapy including Applied Behavior Analysis (ABA) and massage therapy, conducted for 45 minutes per session, 4 times weekly, for 16 weeks (64 total sessions). These sessions did not include sensory-specific interventions.	Behavioral: Conventional therapy group; Conventional therapy sessions consisting of Applied Behavior Analysis (ABA) and massage therapy without specific sensory-motor integration activities. Each session lasted 45 minutes, conducted four times weekly, for a total of 64 sessions over 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Sensory Profile (SSP)	Change in sensory processing	16 weeks
Berg Balance Scale (BBS)	Change in functional balance	16 weeks

Collaborators and Investigators

• Sponsor: Assiut University
• Collaborators: King Saud University; Taif University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: EgyCTR102024002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) collected during the trial will be shared, including baseline characteristics, Short Sensory Profile (SSP) scores, and Berg Balance Scale (BBS) outcomes. No personally identifiable information will be shared.
• IPD Sharing Time Frame: IPD and supporting documents will be made available beginning 6 months after publication of the primary results and will remain accessible for at least 5 years.
• IPD Sharing Access Criteria: Qualified researchers and healthcare professionals can request access to the data for scientific purposes. Requests should include a brief research proposal and data use agreement. Access will be granted through a secure platform or upon direct request to the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No