NCT07576907

Brief Summary

This study will adopt a quasi-experimental design, featuring assessments before and after the intervention for both the experimental and control groups. We plan to recruit thirty children aged 9 to 11 years, all diagnosed with ASD, from a local clinical setting. Participants will be randomly assigned to either a treatment group, which will undergo 12 sessions of sensory-motor integration exercises, or a control group that will receive standard care. Each session will include structured sensory-based activities based on Ayres Sensory Integration® principles.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Apr 2026Jul 2026

Study Start

First participant enrolled

April 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Motor Skills DisordersSensory Processing Disorder

Keywords

Autism Spectrum DisorderSensory IntegrationMotor SkillsSensory Processing Disorders

Outcome Measures

Primary Outcomes (1)

  • TGMD-2

    The Test of Gross Motor Development-2 (TGMD-2) is a standardized assessment used to evaluate gross motor skills in children aged 3-10 years. It measures locomotor and object control skills, with each performance criterion scored as 1 (present) or 0 (absent). The raw score for each subtest ranges from 0 (lowest) to 48 (highest), while the overall Gross Motor Quotient (GMQ) ranges from 46 to 160, with higher scores indicating better motor performance.

    3rd Day

Study Arms (1)

Ayre's sensoray integration exercises

EXPERIMENTAL

Conducted over 12 sessions (3 times/week for 4 weeks), each session lasting \~45 minutes. Exercises based on Ayres' sensory integration therapy and included, Activities for tactile, proprioceptive, and vestibular stimulation. Tasks like pressing play dough, crawling, balancing, jumping, swinging, and obstacle navigation. Sessions were individualized and child-centred to promote adaptive responses

Other: Ayre's Sensory-Motor Integration Exercises

Interventions

Ayre's Sensory-Motor Integration ExercisesOTHER

Ayres' Sensory-Motor Integration Exercises are play-based therapeutic activities designed to improve how children process sensory information. They target tactile, proprioceptive, and vestibular systems through tasks like swinging, balancing, crawling, and object manipulation. Sessions are individualized and child-centered to promote adaptive responses, motor coordination, and functional skills.

Ayre's sensoray integration exercises

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of Autism Spectrum Disorder (ASD) confirmed by a psychiatrist/psychologist.
  • Children aged 9-11 years.
  • Moderate severity of ASD.

You may not qualify if:

  • Use of any sedative/hypnotic drugs.
  • Comorbid psychological or neurological disorders (e.g., epilepsy).
  • Withdrawal of consent at any point during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allied Hospital

Faisalābad, Punjab Province, Pakistan

RECRUITING

Related Publications (3)

  • Lu M, Pang F, Wang R, Liu Y, Peng T. The association between autistic traits and excessive smartphone use in Chinese college students: The chain mediating roles of social interaction anxiety and loneliness. Res Dev Disabil. 2022 Dec;131:104369. doi: 10.1016/j.ridd.2022.104369. Epub 2022 Oct 26.

    PMID: 36306598BACKGROUND

  • Miller LJ, Anzalone ME, Lane SJ, Cermak SA, Osten ET. Concept evolution in sensory integration: a proposed nosology for diagnosis. Am J Occup Ther. 2007 Mar-Apr;61(2):135-40. doi: 10.5014/ajot.61.2.135. No abstract available.

    PMID: 17436834BACKGROUND

  • Martel M, Finos L, Bahmad S, Koun E, Salemme R, Sonie S, Fourneret P, Schmitz C, Roy AC. Motor deficits in autism differ from that of developmental coordination disorder. Autism. 2024 Feb;28(2):415-432. doi: 10.1177/13623613231171980. Epub 2023 May 25.

    PMID: 37226824BACKGROUND

MeSH Terms

Conditions

Motor Skills DisordersAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersChild Development Disorders, Pervasive

Study Officials

  • Eram Aslam, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125imran.amjad@riphah.edu.pk

Muhammad Asif Javed, PhD*

CONTACT

+923224209422a.javed@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)