Autism Spectrum DisorderNCT07921199
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
A study testing Augumented Reality-Based Training and Sensory-Integration Therapy in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine and contrast the effects of Sensory Integration Therapy (SIT) and Augmented Reality-Based Training (AR) on gross motor skills, assessed using the Test of Gross Motor Development-Third Edition (TGMD-3), 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?
- Augumented Reality-Based Training 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
- Nov 2026to Jun 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.
- Diagnosed with Autism Spectrum Disorder according to DSM-5.
- CARS (Childhood Autism Rating Scale) score of 30-36 (mild to moderate autism).
- Able to follow simple verbal instructions and cooperate with assessment.
- Parental/guardian written informed consent obtained.
Who cannot join
- Severe visual or auditory impairment precluding participation in AR-based interventions.
- Co-existing genetic syndromes (e.g., Down syndrome, Rett syndrome).
- Orthopedic deformities or musculoskeletal conditions limiting movement.
- History of recent surgery within the past 6 months.
- Currently receiving any other structured motor or sensory rehabilitation program.
- Seizure disorder or epilepsy not controlled by medications.
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
Smart Start Academe SSA G-8 Markaz
Islamabad, Federal, 44000
Umama Waheed, Ms-PPT*, 03355823347, umem.kkhan@gmail.com
Umama Waheed, Ms-PPT*
About this study
Official title: Comparative Effectivness of Sensory-integration Therapy Verses Augumented Reality-based Training on Gross Motor Skills and Balance in Children With Autism Spectrum Disorder
To determine and contrast the effects of Sensory Integration Therapy (SIT) and Augmented Reality-Based Training (AR) on gross motor skills, assessed using the Test of Gross Motor Development-Third Edition (TGMD-3), in children with Autism Spectrum Disorder. To assess the impact of Sensory Integration Therapy and Augmented Reality-Based Training on balance, measured using the Pediatric Balance Scale (PBS), and determine which intervention yields superior outcomes in children with Autism Spectrum Disorder.To examine post-intervention Short Sensory Profile (SSP) scores between the two treatments groups following 8 weeks of intervention, in order to identify differential improvements in sensory processing. To determine changes in autism severity, using the Childhood Autism Rating Scale (CARS), from baseline to post-intervention, and to analyze whether Sensory Integration Therapy or Augmented Reality Based Training results in greater improvement.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Augumented Reality-Based Training, 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.
Augumented Reality-Based TrainingOther
The experimental will receive Augmented Reality (AR)-based training involving interactive virtual reaching, stepping, locomotor, and balance exercises with real-time visual and auditory feedback. In both groups, the intervention intensity and task complexity will be progressively increased throughout the 8-week program to optimize improvements in gross motor skills and balance.
Sensory-Integration TherapyOther
Participants in both groups will receive supervised interventions 3 times per week for eight weeks (24 sessions), with each session lasting 45-60 minutes, including a 5-minute warm-up, 35-50 minutes of intervention, and a 5minute cool-down.
The control group will receive conventional Sensory Integration-Therapy (SIT), comprising vestibular, tactile, gross motor, and balance activities with progressive therapist-guided difficulty over the period of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Augumented Reality-Based Training | Experimental | Not described Receives: Other: Augumented Reality-Based Training |
| Sensory-Integration Therapy | Active comparator | Not described Receives: Other: Sensory-Integration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Gross Motor Development-Third Edition
To compare the effects of sensory integration therapy and augmented reality-based training on gross motor skills using TGMD-3. According to the TGMD-3 scoring guidance, each performance criterion receives 0 or 1 point. The assessment includes 13 skills, with six locomotor skills and seven ball skills.
Measured: 8 weeks
Pediatric Balance Scale
14-item scale assessing static and dynamic balance. Measured at baseline and post-intervention.The PBS assesses functional balance in children through 14 tasks. Each task is scored from 0 to 4, giving a maximum total score of 56.
Measured: 8 weeks
Secondary outcomes (2)
Short Sensory Profile
The Short Sensory Profile (SSP) is a 38-item caregiver questionnaire used to identify sensory processing difficulties in children with ASD . Each item is scored from 1 to 5, giving a total score ranging from 38 to 190.
Measured: 8 weeks
Childhood Autism Rating Scale
The Childhood Autism Rating Scale (CARS) is used to assess autism-related behaviors and help determine the severity of autism-related characteristics.Each item is scored from 1 to 4, using half-point increments when appropriate. There are 15 items, so the total score ranges from 15 to 60.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qamar Mahmood, Phd, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921199
- Sponsor's protocol ID
- REC/MS-PT/02579
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectivness of Sensory-integration Therapy Verses Augumented Reality-based Training on Gross Motor Skills and Balance in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07921199
- Acronym / sponsor ID
- REC/MS-PT/02579
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 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 determine and contrast the effects of Sensory Integration Therapy (SIT) and Augmented Reality-Based Training (AR) on gross motor skills, assessed using the Test of Gross Motor Development-Third Edition (TGMD-3), in children with Autism Spectrum Disorder. To assess the impact of Sensory Integration Therapy and Augmented Reality-Based Training on balance, measured using the Pediatric Balance Scale (PBS), and determine which intervention yields superior outcomes in children with Autism Spectrum Disorder.To examine post-intervention Short Sensory Profile (SSP) scores between the two treatments groups following 8 weeks of intervention, in order to identify differential improvements in sensory processing. To determine changes in autism severity, using the Childhood Autism Rating Scale (CARS), from baseline to post-intervention, and to analyze whether Sensory Integration Therapy or Augmented Reality Based Training results in greater improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augumented Reality-Based Training | Experimental | Other: Augumented Reality-Based Training |
| Sensory-Integration Therapy | Active comparator | Other: Sensory-Integration Therapy |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 4-10 years.
- Diagnosed with Autism Spectrum Disorder according to DSM-5.
- CARS (Childhood Autism Rating Scale) score of 30-36 (mild to moderate autism).
- Able to follow simple verbal instructions and cooperate with assessment.
- Parental/guardian written informed consent obtained.
Key exclusion criteria (6 listed)
- Severe visual or auditory impairment precluding participation in AR-based interventions.
- Co-existing genetic syndromes (e.g., Down syndrome, Rett syndrome).
- Orthopedic deformities or musculoskeletal conditions limiting movement.
- History of recent surgery within the past 6 months.
- Currently receiving any other structured motor or sensory rehabilitation program.
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 |
|---|---|---|
| Augumented Reality-Based TrainingThe experimental will receive Augmented Reality (AR)-based training involving interactive virtual reaching, stepping, locomotor, and balance exercises with real-time visual and auditory feedback. In both groups, the intervention intensity and task complexity will be progressively increased throughout the 8-week program to optimize improvements in gross motor skills and balance. | Other | Augumented Reality-Based Training |
| Sensory-Integration TherapyParticipants in both groups will receive supervised interventions 3 times per week for eight weeks (24 sessions), with each session lasting 45-60 minutes, including a 5-minute warm-up, 35-50 minutes of intervention, and a 5minute cool-down. The control group will receive conventional Sensory Integration-Therapy (SIT), comprising vestibular, tactile, gross motor, and balance activities with progressive therapist-guided difficulty over the period of 8 weeks. | Other | Sensory-Integration Therapy |
Primary outcome
Test of Gross Motor Development-Third Edition
Time frame: 8 weeks
To compare the effects of sensory integration therapy and augmented reality-based training on gross motor skills using TGMD-3. According to the TGMD-3 scoring guidance, each performance criterion receives 0 or 1 point. The assessment includes 13 skills, with six locomotor skills and seven ball skills.
Pediatric Balance Scale
Time frame: 8 weeks
14-item scale assessing static and dynamic balance. Measured at baseline and post-intervention.The PBS assesses functional balance in children through 14 tasks. Each task is scored from 0 to 4, giving a maximum total score of 56.
2 secondary outcomes
Short Sensory Profile
Time frame: 8 weeks
Childhood Autism Rating Scale
Time frame: 8 weeks
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 6 Nov 2026.
- 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.
Qamar Mahmood, Phd principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augumented Reality-Based Training 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 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 Qamar Mahmood, PhD (03335151063, qamarmahmood@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Gross Motor Development-Third Edition (time frame: 8 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 6 Nov 2026.