- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07576907
Ayre's Sensory-Motor Integration Exercises and Sensory Modulation And Motor Skills In Children With ASD
Effects of Ayre's Sensory-Motor Integration Exercises On Sensory Modulation And Motor Skills In Children With Autism Spectrum Disorder
Study Overview
Status
Intervention / Treatment
Detailed Description
Autism Spectrum Disorder (ASD) is increasingly affecting children around the globe, bringing with it a variety of behavioral, social, and developmental hurdles.
One of the more subtle yet significant challenges faced by many children with ASD is trouble with sensory modulation and motor coordination. These kids often find it hard to process sensory information in a way that allows them to engage meaningfully with their surroundings. As a result, they may experience behavioral issues, struggle with motor planning, and have a harder time participating in daily activities. To help with this, sensory-motor integration exercises are designed to enhance how the nervous system interprets and reacts to sensory input, leading to smoother and more coordinated physical responses. While these therapies have been looked into in various parts of the world, their application in structured and culturally relevant ways in South Asia is still quite limited. This project seeks to explore how a sensory-motor integration intervention can impact sensory responsiveness and motor skill development in children with ASD. This study will adopt a quasi-experimental design, featuring assessments before and after the intervention for both the experimental and control groups. We plan to recruit thirty children aged 9 to 11 years, all diagnosed with ASD, from a local clinical setting. Participants will be randomly assigned to either a treatment group, which will undergo 12 sessions of sensory-motor integration exercises, or a control group that will receive standard care. Each session will include structured sensory-based activities based on Ayres Sensory Integration® principles. We will utilize tools TGMD and Sensory Modulation Assessment Tool to evaluate outcomes. The quantitative data collected will be analyzed to compare improvements in sensory and motor skills between the two groups. The goal is to support the incorporation of sensory-motor strategies into rehabilitation programs for children with ASD, especially in low-resource settings.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, PhD*
- Phone Number: +923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
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Punjab Province
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Faisalābad, Punjab Province, Pakistan
- Recruiting
- Allied Hospital
-
Principal Investigator:
- Maha Sattar, MS-PPT
-
Sub-Investigator:
- Eram Aslam, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of Autism Spectrum Disorder (ASD) confirmed by a psychiatrist/psychologist.
- Children aged 9-11 years.
- Moderate severity of ASD.
Exclusion Criteria:
- Use of any sedative/hypnotic drugs.
- Comorbid psychological or neurological disorders (e.g., epilepsy).
- Withdrawal of consent at any point during the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ayre's sensoray integration exercises
Conducted over 12 sessions (3 times/week for 4 weeks), each session lasting ~45 minutes. Exercises based on Ayres' sensory integration therapy and included, Activities for tactile, proprioceptive, and vestibular stimulation. Tasks like pressing play dough, crawling, balancing, jumping, swinging, and obstacle navigation. Sessions were individualized and child-centred to promote adaptive responses |
Ayres' Sensory-Motor Integration Exercises are play-based therapeutic activities designed to improve how children process sensory information.
They target tactile, proprioceptive, and vestibular systems through tasks like swinging, balancing, crawling, and object manipulation.
Sessions are individualized and child-centered to promote adaptive responses, motor coordination, and functional skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TGMD-2
Time Frame: 3rd Day
|
The Test of Gross Motor Development-2 (TGMD-2) is a standardized assessment used to evaluate gross motor skills in children aged 3-10 years.
It measures locomotor and object control skills, with each performance criterion scored as 1 (present) or 0 (absent).
The raw score for each subtest ranges from 0 (lowest) to 48 (highest), while the overall Gross Motor Quotient (GMQ) ranges from 46 to 160, with higher scores indicating better motor performance.
|
3rd Day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eram Aslam, MS, Riphah International University
Publications and helpful links
General Publications
- Miller LJ, Anzalone ME, Lane SJ, Cermak SA, Osten ET. Concept evolution in sensory integration: a proposed nosology for diagnosis. Am J Occup Ther. 2007 Mar-Apr;61(2):135-40. doi: 10.5014/ajot.61.2.135. No abstract available.
- Lu M, Pang F, Wang R, Liu Y, Peng T. The association between autistic traits and excessive smartphone use in Chinese college students: The chain mediating roles of social interaction anxiety and loneliness. Res Dev Disabil. 2022 Dec;131:104369. doi: 10.1016/j.ridd.2022.104369. Epub 2022 Oct 26.
- Martel M, Finos L, Bahmad S, Koun E, Salemme R, Sonie S, Fourneret P, Schmitz C, Roy AC. Motor deficits in autism differ from that of developmental coordination disorder. Autism. 2024 Feb;28(2):415-432. doi: 10.1177/13623613231171980. Epub 2023 May 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah/G-III/RCR&AHS/B45-185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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