Autism Spectrum DisorderNCT06882642
Sensory Integration Therapy in a Sample of Children With Autism Spectrum Disorder
A study testing Sensory integration therapy in people with Autism Spectrum Disorder and Children, run by Ain Shams University at 1 site in Egypt.
Trial summary
The objective of this study is to determine the effects of therapy in sensory rooms with multisensory environment on the severity of autism spectrum disorder and stereotyped and repetitive behaviours in a sample of Egyptian children with autism spectrum disorder Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder, Children, Therapy
- What is being tested?
- Sensory integration therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensory Integration Therapy in a Sample of Children With Autism Spectrum Disorder; an Outcome Study
The objective of this study is to determine the effects of therapy in sensory rooms with multisensory environment on the severity of autism spectrum disorder and stereotyped and repetitive behaviours in a sample of Egyptian children with autism spectrum disorder
Read the 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.
- Conditions
- Autism Spectrum Disorder, Children, Therapy
- Being tested
- Sensory integration therapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory integration therapyProcedure or surgery
Autistic patients will undergo sensory integration therapy
| Study group | Role | What they receive |
|---|---|---|
| Sensory integration therapy | Experimental | Autistic patients will undergo sensory integration therapy Receives: Procedure: Sensory integration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of sensory integration therapy
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 May 2023
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahaf Mohamed Abdelrahman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882642
- Sponsor's protocol ID
- FMASU MD71/2023
- Status last verified
- May 2025
- First submitted
- 27 Feb 2025
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Rahman RMA, Sayed MM, Samei AMA, El Sheikh MM, Mohamed MY. Outcomes of sensory integration therapy in children with autism spectrum disorder: a non-randomized pre-post intervention study. BMC Pediatr. 2026 Oct 22;26(1):1094. doi: 10.1186/s12887-026-07568-x.
PubMed 42972283
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Integration Therapy in a Sample of Children With Autism Spectrum Disorder; an Outcome Study
- ClinicalTrials.gov ID
- NCT06882642
- Acronym / sponsor ID
- FMASU MD71/2023
- Conditions
- Autism Spectrum Disorder, Children, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the effects of therapy in sensory rooms with multisensory environment on the severity of autism spectrum disorder and stereotyped and repetitive behaviours in a sample of Egyptian children with autism spectrum disorder
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sensory integration therapy | Experimental | Procedure: Sensory integration therapyAutistic patients will undergo sensory integration therapy |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory integration therapyAutistic patients will undergo sensory integration therapy | Procedure or surgery | Sensory integration therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 42972283Rahman RMA, Sayed MM, Samei AMA, El Sheikh MM, Mohamed MY. Outcomes of sensory integration therapy in children with autism spectrum disorder: a non-randomized pre-post intervention study. BMC Pediatr. 2026 Oct 22;26(1):1094. doi: 10.1186/s12887-026-07568-x.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory integration therapy in people with Autism Spectrum Disorder and Children, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of sensory integration therapy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06882642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.