NCT06922422

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 3, 2025

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Short Sensory Profile (SSP)

    Change in sensory processing

    16 weeks

  • Berg Balance Scale (BBS)

    Change in functional balance

    16 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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 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.

Control group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport Sciences, Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 10, 2025

Study Start

March 13, 2024

Primary Completion

September 15, 2024

Study Completion

December 15, 2024

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.
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.

Locations