Autism Spectrum Disorder (ASD)SMIE-ASDNCT06922422
Sensory-Motor Integration for Sensory Processing and Balance in ASD
A study testing Sensory-Motor Integration Exercises and Conventional therapy group in people with Autism Spectrum Disorder (ASD), run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- Sensory-Motor Integration Exercises and Conventional therapy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Mar 2024to 15 Dec 2024
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Significant physical impairments or medical conditions affecting participation
- Recent (within 6 months) participation in sensory integration therapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Sport Sciences, Assiut University
Asyut, Asyut Governorate, 71515
About this study
Official title: The Effects of Sensory-Motor Integration Exercises on Sensory Processing and Balance in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
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.
Read the detailed description
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
- Autism Spectrum Disorder (ASD)
- Being tested
- Sensory-Motor Integration Exercises, Conventional therapy group
- 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-Motor Integration ExercisesBehavioural
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.
Conventional therapy groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Conventional therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Sensory Profile (SSP)
Change in sensory processing
Measured: 16 weeks
Berg Balance Scale (BBS)
Change in functional balance
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start13 Mar 2024
- Primary completion15 Sep 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud University, Taif University
- Responsible party
- Principal investigator, Mohamed Aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922422
- Sponsor's protocol ID
- EgyCTR102024002
- Acronym
- SMIE-ASD
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sensory-Motor Integration Exercises on Sensory Processing and Balance in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06922422
- Acronym / sponsor ID
- SMIE-ASD / EgyCTR102024002
- Conditions
- Autism Spectrum Disorder (ASD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- King Saud University, Taif University
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 10 Apr 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.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Sensory-Motor Integration ExercisesParticipants 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). |
| Control group | Active comparator | Behavioral: Conventional therapy groupParticipants 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Significant physical impairments or medical conditions affecting participation
- Recent (within 6 months) participation in sensory integration therapy
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-Motor Integration ExercisesA 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. | Behavioural | Intervention group |
| Conventional therapy groupConventional 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. | Behavioural | Control group |
Primary outcome
Short Sensory Profile (SSP)
Time frame: 16 weeks
Change in sensory processing
Berg Balance Scale (BBS)
Time frame: 16 weeks
Change in functional balance
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 10 Apr 2025.
- Individual participant dataSharing planned: Yes. 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.
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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-Motor Integration Exercises and Conventional therapy group in people with Autism Spectrum Disorder (ASD), run by Assiut 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 4 inclusion and 2 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 10 Apr 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?
Short Sensory Profile (SSP) (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2025.