- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06661369
Study Comparing the Effects of SPM Techniques, Individually vs. Grouped in Children With ASD
December 20, 2024 updated by: Riphah International University
Comparative Effects of Individual and Grouped Sensory Perceptual Motor Training on Gross Motor Skills and Quality of Life in Children With Autism Spectrum Disorder
Autism is the most prevalent disorder as it affects attention, awareness, cognitive development, social development, and emotional aspects too.
It is one of the comprehensive developmental disorders in the early stage, which is characterized by weak social learning and communication, limited activities, interests, learning, insufficient imaginative and stereotypical thinking or non-functional thinking of movements and verbalities.
A lack of sensory perception leads to a leading autistic child's sensitivity to sensory stimuli or weak sensitivity and the child is not aware of the surrounding environment.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The current study will be randomized control trial; data will be collected from Lahore Garrison Institute of Special Education.
This study will be conducted with 32 participants equally divided into two groups.
Inclusion criteria will be Children who diagnosed with Autism Spectrum Disorder (mild & moderate) according to Diagnostic and Statistical Manual of Mental Disorders, (DSM-5), Have an IQ 70 according to Stanford-Binet Intelligence Scales and be able to understand and follow instructions, Children whose age between 4 to 12 and All participants had to be able to sit and walk without support according to GMFCS.
Exclusion criteria for the study include Children who will associate with attention deficit hyperactivity disorder signs, Upper limb musculoskeletal injuries, Visual or auditory impairments, Children who had received sensory integration therapy for > 3 months within the past 6 months and Children with speech delay, hearing impairment, or intellectual disability.
SPM training will be given each child individually in the first group.
In the second group techniques will be apply in a group therapy.
The SPM training programme will apply for 10 months.
Outcomes, including the Test of Movement Battery for Children, Quality of life scale will be use.
Data analysis will be performed using SPSS version 23.00
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: IMRAN AMJAD, PHD
- Phone Number: +9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS
- Phone Number: +923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore,, Punjab, Pakistan, 54000
- Recruiting
- Riphah International University,
-
Contact:
- IMRAN AMJAD, PHD
- Phone Number: +9233224390125
- Email: imran.amjad@riphah.edu.pk
-
Contact:
- Muhammad Asif Javed, MS
- Phone Number: +923224209422
- Email: a.javed@riphah.edu.pk
-
Principal Investigator:
- Sara Sattar, MS*
-
Sub-Investigator:
- Mahrukh Badar, MS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children who diagnosed with Autism Spectrum Disorder (mild & moderate) according to Diagnostic and Statistical Manual of Mental Disorders, (DSM-5)
- Have an IQ 70 according to Stanford-Binet Intelligence Scales
- Children whose age between 4 to 12
- All participants had to be able to sit and walk without support
Exclusion Criteria:
- Children who will associate with attention deficit hyperactivity disorder signs
- Upper limb musculoskeletal injuries
- Visual or auditory impairments
- Children who had received sensory integration therapy for > 3 months within the past 6 months
- Children with speech delay, hearing impairment, or intellectual disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individual ASD Children
Activities were applied individually for the IND group.
Individual training was applied according to the treatment protocol, activities done by step by step from simple to complex.
Each activities for individuals training will be applied for 2 hours, three sessions per week, for ten successive months
|
|
|
Experimental: Group of ASD Children
Activities were applied in group .
Group training was applied according to the treatment protocol, activities done by step by step from simple to complex.
each activities for group training will be applied for 2 hours, three sessions per week, for ten successive months
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
THE DEVELOPMENTAL COORDINATION The Developmental Coordination Disorder Questionnaire
Time Frame: 10-15 minutes
|
The Developmental Coordination Disorder Questionnaire (DCDQ) is a parent-report screening tool for identifying motor coordination difficulties in children aged 5 to 15 years, 11 months.
It includes 15 items across three domains: Control During Movement, Fine Motor/Handwriting, and General Coordination, rated on a 5-point Likert scale.
Scores below age-specific cutoffs suggest potential Developmental Coordination Disorder (DCD).
It is reliable, quick (10-15 min), but not diagnostic, requiring further evaluation.
|
10-15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Sensory Profile
Time Frame: 2-5 hours
|
The Short Sensory Profile (SSP) is a caregiver-completed questionnaire used to assess sensory processing difficulties in children aged 3-14 years.
It includes 38 items across seven domains (e.g., tactile sensitivity, auditory filtering), rated on a 5-point scale.
Scores help identify sensory modulation issues affecting daily activities.
The SSP is quick, reliable, and widely used, but it is a screening tool, not a diagnostic instrument.
|
2-5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sara Sattar, MS*, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 26, 2024
Primary Completion (Estimated)
January 15, 2025
Study Completion (Estimated)
January 20, 2025
Study Registration Dates
First Submitted
October 24, 2024
First Submitted That Met QC Criteria
October 25, 2024
First Posted (Actual)
October 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 20, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/Sara Sattar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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