Autism Spectrum DisorderNCT07911904
SIT and Deep Pressure Therapy Effects on Motor Coordination in Children With ASD
A study testing Sensory Integration therapy and Deep Pressure therapy and Sensory Integration Therapy in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
To evaluate the combined effect of Sensory Integration Therapy and Deep Pressure Therapy on motor coordination and stereotypical behaviors in children with Autism Spectrum Disorder Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Sensory Integration therapy and Deep Pressure therapy and Sensory Integration Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4-10 years.
- Both male and female children diagnosed with autism spectrum disorder.
- Presence of motor coordination difficulties and stereotypical behaviors.
- Children able to follow simple instructions
Who cannot join
- Children with severe intellectual disability or uncooperative behavior that hinders therapy.
- Children with uncontrolled epilepsy or other neurological conditions apart from ASD.
- Children with severe visual, auditory, or orthopedic impairments affecting motor coordination and behaviors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Army Special Education Academy
Rawalpindi, Punjab Province, 46000
Ayesha Bashir, MS, 03335256920, ayesha.bashir@riphah.edu.pk
Abdullah Jan, MSPT(MSPPT)
About this study
Official title: Combined Effects of Sensory Integration Therapy and Deep Pressure Therapy on Motor Coordination And Stereotypic Behaviors In Children With Autism Spectrum Disorder
To evaluate the combined effect of Sensory Integration Therapy and Deep Pressure Therapy on motor coordination and stereotypical behaviors in children with Autism Spectrum Disorder
- Conditions
- Autism Spectrum Disorder
- Being tested
- Sensory Integration therapy and Deep Pressure therapy, Sensory Integration Therapy
- Keywords
- Motor Coordination, Sensory Integration therapy, Deep Pressure 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 therapy and Deep Pressure therapyOther
Basic sensory integration activities targeting tactile, vestibular, visual, and proprioceptive systems + deep pressure therapy through joint compressions and firm tactile input. Sessions will be conducted 3 times per week for 8 weeks (total 24 sessions), with each session lasting 45 minutes.
Sensory Integration TherapyOther
Basic sensory integration activities targeting tactile, vestibular, and proprioceptive systems. Sessions will be conducted 3 times per week for 8 weeks (total 24 sessions), with each session lasting 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Integration therapy and Deep Pressure therapy | Experimental | Sensory Integration Therapy and Deep Pressure Therapy Combined Effect on Motor Coordination and Stereotypic Behaviors Receives: Other: Sensory Integration therapy and Deep Pressure therapy |
| Sensory Integration Therapy | Active comparator | Sensory Integration Therapy's Effect alone on Motor Coordination and Stereotypic Behaviors Receives: Other: Sensory Integration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor coordination as measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
The BOT-2 is a standardized, performance-based test of fine and gross motor skills. Performance is converted to standard scores (mean 50, SD 10), and higher scores indicate better motor proficiency. Motor coordination will be measured as the change from baseline (week 0) to mid-intervention (week 4) and to post-intervention (week 8).
Measured: Baseline (week 0), week 4, and week 8
Secondary outcomes (1)
Change in stereotypic behavior as measured by the Repetitive Behavior Scale-Revised (RBS-R)
The RBS-R is a 43-item caregiver-rated scale. Each item is scored 0 to 3, and higher scores indicate more severe repetitive behavior. The Stereotyped Behavior subscale (6 items, score range 0 to 18) will be used to measure stereotypic behavior as the change from baseline (week 0) to week 4 and to week 8.
Measured: Baseline (week 0), week 4, and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Jul 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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 Riphah International 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Bashir, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911904
- Sponsor's protocol ID
- REC/MS-PT/02471 Abdullah Jan
- Status last verified
- Nov 2026
- First submitted
- 16 Jul 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wen L, Wu Z. The impact of sensory integration based sports training on motor and social skill development in children with autism spectrum disorder. Sci Rep. 2025 Jun 6;15(1):19974. doi: 10.1038/s41598-025-05393-3.
PubMed 404812161.Pellecchia M, Dickson KS, Vejnoska SF, Stahmer AC. The autism spectrum: Diagnosis and epidemiology. 2021.
Farooq MS, Tehseen R, Sabir M, Atal Z. Detection of autism spectrum disorder (ASD) in children and adults using machine learning. Sci Rep. 2023 Jun 13;13(1):9605. doi: 10.1038/s41598-023-35910-1.
PubMed 37311766Hadad BS, Yashar A. Sensory Perception in Autism: What Can We Learn? Annu Rev Vis Sci. 2022 Sep 15;8:239-264. doi: 10.1146/annurev-vision-093020-035217. Epub 2022 Jul 8.
PubMed 35804481Kirby AV, Bilder DA, Wiggins LD, Hughes MM, Davis J, Hall-Lande JA, Lee LC, McMahon WM, Bakian AV. Sensory features in autism: Findings from a large population-based surveillance system. Autism Res. 2022 Apr;15(4):751-760. doi: 10.1002/aur.2670. Epub 2022 Jan 18.
PubMed 35040592Hazen EP, Stornelli JL, O'Rourke JA, Koesterer K, McDougle CJ. Sensory symptoms in autism spectrum disorders. Harv Rev Psychiatry. 2014 Mar-Apr;22(2):112-24. doi: 10.1097/01.HRP.0000445143.08773.58.
PubMed 24614766Randell E, Wright M, Milosevic S, Gillespie D, Brookes-Howell L, Busse-Morris M, Hastings R, Maboshe W, Williams-Thomas R, Mills L, Romeo R, Yaziji N, McKigney AM, Ahuja A, Warren G, Glarou E, Delport S, McNamara R. Sensory integration therapy for children with autism and sensory processing difficulties: the SenITA RCT. Health Technol Assess. 2022 Jun;26(29):1-140. doi: 10.3310/TQGE0020.
PubMed 35766242Singhi P, Malhi P. Early Diagnosis of Autism Spectrum Disorder: What the Pediatricians Should Know. Indian J Pediatr. 2023 Apr;90(4):364-368. doi: 10.1007/s12098-022-04363-1. Epub 2022 Oct 18.
PubMed 36255651Bestbier L, Williams TI. The Immediate Effects of Deep Pressure on Young People with Autism and Severe Intellectual Difficulties: Demonstrating Individual Differences. Occup Ther Int. 2017 Jan 9;2017:7534972. doi: 10.1155/2017/7534972. eCollection 2017.
PubMed 29097980Bremer E, Cairney J. The Interrelationship Between Motor Coordination and Adaptive Behavior in Children With Autism Spectrum Disorder. Front Psychol. 2018 Nov 27;9:2350. doi: 10.3389/fpsyg.2018.02350. eCollection 2018.
PubMed 30538659Negin F, Ozyer B, Agahian S, Kacdioglu S, Ozyer GT. Vision-assisted recognition of stereotype behaviors for early diagnosis of autism spectrum disorders. Neurocomputing. 2021;446:145-55.
Losinski M, Cook K, Hirsch S, Sanders S. The effects of deep pressure therapies and antecedent exercise on stereotypical behaviors of students with autism spectrum disorders. Behavioral Disorders. 2017;42(4):196-208.
Hemati Alamdarloo G, Mradi H. The effectiveness of sensory integration intervention on the emotional-behavioral problems of children with autism spectrum disorder. Advances in Autism. 2021;7(2):152-66.
Samad A, Aslam FM, Khan H, Tabassum M. Effects of sensory integration to manage behavior problems of children with autism spectrum disorder. Allied Medical Research Journal. 2024;2(1):203-12.
Bruininks RH, Bruininks BD. Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2). Minneapolis (MN): Pearson Assessment; 2005.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Sensory Integration Therapy and Deep Pressure Therapy on Motor Coordination And Stereotypic Behaviors In Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07911904
- Acronym / sponsor ID
- REC/MS-PT/02471 Abdullah Jan
- Conditions
- Autism Spectrum Disorder
- Keywords
- Motor Coordination, Sensory Integration therapy, Deep Pressure Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
To evaluate the combined effect of Sensory Integration Therapy and Deep Pressure Therapy on motor coordination and stereotypical behaviors in children with Autism Spectrum Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory Integration therapy and Deep Pressure therapy | Experimental | Other: Sensory Integration therapy and Deep Pressure therapySensory Integration Therapy and Deep Pressure Therapy Combined Effect on Motor Coordination and Stereotypic Behaviors |
| Sensory Integration Therapy | Active comparator | Other: Sensory Integration TherapySensory Integration Therapy's Effect alone on Motor Coordination and Stereotypic Behaviors |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 4-10 years.
- Both male and female children diagnosed with autism spectrum disorder.
- Presence of motor coordination difficulties and stereotypical behaviors.
- Children able to follow simple instructions
Key exclusion criteria (3 listed)
- Children with severe intellectual disability or uncooperative behavior that hinders therapy.
- Children with uncontrolled epilepsy or other neurological conditions apart from ASD.
- Children with severe visual, auditory, or orthopedic impairments affecting motor coordination and behaviors
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 therapy and Deep Pressure therapyBasic sensory integration activities targeting tactile, vestibular, visual, and proprioceptive systems + deep pressure therapy through joint compressions and firm tactile input. Sessions will be conducted 3 times per week for 8 weeks (total 24 sessions), with each session lasting 45 minutes. | Other | Sensory Integration therapy and Deep Pressure therapy |
| Sensory Integration TherapyBasic sensory integration activities targeting tactile, vestibular, and proprioceptive systems. Sessions will be conducted 3 times per week for 8 weeks (total 24 sessions), with each session lasting 45 minutes. | Other | Sensory Integration Therapy |
Primary outcome
Change in motor coordination as measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Time frame: Baseline (week 0), week 4, and week 8
The BOT-2 is a standardized, performance-based test of fine and gross motor skills. Performance is converted to standard scores (mean 50, SD 10), and higher scores indicate better motor proficiency. Motor coordination will be measured as the change from baseline (week 0) to mid-intervention (week 4) and to post-intervention (week 8).
1 secondary outcome
Change in stereotypic behavior as measured by the Repetitive Behavior Scale-Revised (RBS-R)
Time frame: Baseline (week 0), week 4, and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 40481216Wen L, Wu Z. The impact of sensory integration based sports training on motor and social skill development in children with autism spectrum disorder. Sci Rep. 2025 Jun 6;15(1):19974. doi: 10.1038/s41598-025-05393-3.
- Background1.Pellecchia M, Dickson KS, Vejnoska SF, Stahmer AC. The autism spectrum: Diagnosis and epidemiology. 2021.
- Background: PubMed 37311766Farooq MS, Tehseen R, Sabir M, Atal Z. Detection of autism spectrum disorder (ASD) in children and adults using machine learning. Sci Rep. 2023 Jun 13;13(1):9605. doi: 10.1038/s41598-023-35910-1.
- Background: PubMed 35804481Hadad BS, Yashar A. Sensory Perception in Autism: What Can We Learn? Annu Rev Vis Sci. 2022 Sep 15;8:239-264. doi: 10.1146/annurev-vision-093020-035217. Epub 2022 Jul 8.
- Background: PubMed 35040592Kirby AV, Bilder DA, Wiggins LD, Hughes MM, Davis J, Hall-Lande JA, Lee LC, McMahon WM, Bakian AV. Sensory features in autism: Findings from a large population-based surveillance system. Autism Res. 2022 Apr;15(4):751-760. doi: 10.1002/aur.2670. Epub 2022 Jan 18.
- Background: PubMed 24614766Hazen EP, Stornelli JL, O'Rourke JA, Koesterer K, McDougle CJ. Sensory symptoms in autism spectrum disorders. Harv Rev Psychiatry. 2014 Mar-Apr;22(2):112-24. doi: 10.1097/01.HRP.0000445143.08773.58.
- Background: PubMed 35766242Randell E, Wright M, Milosevic S, Gillespie D, Brookes-Howell L, Busse-Morris M, Hastings R, Maboshe W, Williams-Thomas R, Mills L, Romeo R, Yaziji N, McKigney AM, Ahuja A, Warren G, Glarou E, Delport S, McNamara R. Sensory integration therapy for children with autism and sensory processing difficulties: the SenITA RCT. Health Technol Assess. 2022 Jun;26(29):1-140. doi: 10.3310/TQGE0020.
- Background: PubMed 36255651Singhi P, Malhi P. Early Diagnosis of Autism Spectrum Disorder: What the Pediatricians Should Know. Indian J Pediatr. 2023 Apr;90(4):364-368. doi: 10.1007/s12098-022-04363-1. Epub 2022 Oct 18.
- Background: PubMed 29097980Bestbier L, Williams TI. The Immediate Effects of Deep Pressure on Young People with Autism and Severe Intellectual Difficulties: Demonstrating Individual Differences. Occup Ther Int. 2017 Jan 9;2017:7534972. doi: 10.1155/2017/7534972. eCollection 2017.
- Background: PubMed 30538659Bremer E, Cairney J. The Interrelationship Between Motor Coordination and Adaptive Behavior in Children With Autism Spectrum Disorder. Front Psychol. 2018 Nov 27;9:2350. doi: 10.3389/fpsyg.2018.02350. eCollection 2018.
- BackgroundNegin F, Ozyer B, Agahian S, Kacdioglu S, Ozyer GT. Vision-assisted recognition of stereotype behaviors for early diagnosis of autism spectrum disorders. Neurocomputing. 2021;446:145-55.
- BackgroundLosinski M, Cook K, Hirsch S, Sanders S. The effects of deep pressure therapies and antecedent exercise on stereotypical behaviors of students with autism spectrum disorders. Behavioral Disorders. 2017;42(4):196-208.
- Individual participant dataSharing planned: No
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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.
Ayesha Bashir, MS principal investigator
Riphah International University
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 and Deep Pressure therapy and Sensory Integration Therapy in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
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 3 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayesha Bashir, MS (03335256920, ayesha.bashir@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor coordination as measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (time frame: Baseline (week 0), week 4, and week 8). 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 NCT07911904, which also lists 17 linked publications.
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 3 Nov 2026.