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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore,, Punjab, Pakistan, 54000
        • Recruiting
        • Riphah International University,
        • Contact:
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Sensory Perceptual Motor Training on Individual

  1. Sensory Input

    • Wheelbarrow walks, swimming, and drying off.

  2. Proprioceptive

    • Climbing, pushing, pulling, and carrying heavy objects.

  3. Vestibular

    • Swinging, trampolining, and playground games.

  4. Tactile

    • Stereognosis training, textured paths, and messy play (mud, sand).

  5. Motor Planning

    • Statue spinning, crawling through/under objects, and quick movements.

  6. Balance and Posture

    • Various balance positions (e.g., hands and knees).

  7. Ocular Control

    • Catching and tossing balls.

  8. Bilateral Coordination

    • Activities using both sides of the body (e.g., stick ball).

  9. Visual-Spatial

    • Walking, stair climbing, and puzzles.

  10. Fine Motor Skills

    • Puzzles, bead stringing, and drawing.

  11. Gross Motor

    • Standing, walking, running, and throwing games.
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
Other: Sensory Perceptual Motor Training on Group

  1. Sensory Input

    • Wheelbarrow walks, swimming, and drying off.

  2. Proprioceptive

    • Climbing, pushing, pulling, and carrying heavy objects.

  3. Vestibular

    • Swinging, trampolining, and playground games.

  4. Tactile

    • Stereognosis training, textured paths, and messy play (mud, sand).

  5. Motor Planning

    • Statue spinning, crawling through/under objects, and quick movements.

  6. Balance and Posture

    • Various balance positions (e.g., hands and knees).

  7. Ocular Control

    • Catching and tossing balls.

  8. Bilateral Coordination

    • Activities using both sides of the body (e.g., stick ball).

  9. Visual-Spatial

    • Walking, stair climbing, and puzzles.

  10. Fine Motor Skills

    • Puzzles, bead stringing, and drawing.

  11. Gross Motor

    • Standing, walking, running, and throwing games.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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