Sensory-Motor Integration for Sensory Processing and Balance in ASD

NCT ID: NCT06922422

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2024-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder (ASD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventions:

* Experimental: Sensory-Motor Integration Exercises
* Sessions: 64 (45 min/session, 4 days/week)
* Duration: 16 weeks
* Components: Tactile, proprioceptive, and vestibular activities designed for individual sensory profiles.
* Active Comparator: Conventional Therapy
* Applied Behavior Analysis (ABA)
* Massage therapy
* Sessions: Same duration (45 min/session, 4 days/week)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Sensory-Motor Integration Exercises

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Conventional therapy group

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Saud University

OTHER

Sponsor Role collaborator

Taif University

OTHER

Sponsor Role collaborator

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Aly

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Sport Sciences, Assiut University

Asyut, Asyut Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EgyCTR102024002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.