- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06882642
Sensory Integration Therapy in a Sample of Children With Autism Spectrum Disorder
Sensory Integration Therapy in a Sample of Children With Autism Spectrum Disorder; an Outcome Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Autism Spectrum Disorder is a neurodevelopmental disorder characterized by deficits in social interactions, social communication and stereotyped behaviours associated with sensory disorders occurring before the age of 3.
According to DSM-5, sensory processing disorders include hyper-reactivity to sensory stimuli which is an adverse response to sensory stimuli (specific sounds or textures, excessive smells), hypo-reactivity as an apparent indifference to sensory stimuli (pain or temperature-hot/cold) and sensory seeking as a strong desire for sensory intake (touching of objects, visual fascination with lights and movements) or unusual sensory interests in the environment.] Multisensory interactions in spatial processing are investigated with functional neuroimaging and electrophysiological recordings. Using fMRI, researchers identified candidate multisensory areas by looking for regions of cortex that are activated by visual and tactile stimuli, showing that multisensory processing in the human brain involves the multisensory areas of ''association'' cortex as well as the modality-specific areas of cortex that are specialized for the processing of stimulus features such as colour, shape and texture.
Ayres Sensory Integration therapy (ASI) is an individualized intervention designed to address the specific underlying sensory-motor issues that may be affecting children's performance during daily routines and activities, including participation within the classroom and in other contexts of the school.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 11591
- Ain Shams University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients included in the study are diagnosed with Autism spectrum disorder according to DSM-V criteria.
- Participants have to have a sensory problem in their diagnostic criteria.
- Age ranges between 3-10 years. (as scope of the study is focused on children)
- Both males and females.
- Parents or guardian agreed to informed consent.
Exclusion Criteria:
- Parents refusing to participate in the research
- Children with comorbid psychiatric and/or neurological disorder
- Children with co-morbid sensory deficit, hearing , vision, and motor deficit
- Intelligence quotient level below 60
- Children who scored typical performance in the sensory profile care-giver questionnaire
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 |
|---|---|
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Experimental: Sensory integration therapy
Autistic patients will undergo sensory integration therapy
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Autistic patients will undergo sensory integration therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of sensory integration therapy
Time Frame: 12 weeks
|
Effect of sensory integration therapy on autism spectrum disorder symptoms and signs and severity.
The sessions are held weekly for 12 weeks, lasting half an hour, and the measurement is done before and after them, taking an hour.
The sensory integration program lasts 12 weeks with 12 sessions, each 30 minutes.
Participants must attend at least 9 sessions.
Afterward, they will be reassessed using CARS and the Sensory Profile Caregiver questionnaire.
The sensory room provides multisensory stimulation through tools like projectors, fibre optics, and auditory devices.
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12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- FMASU MD71/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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