NCT06661369

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

October 24, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

autism spectrum disordersensory perceptual motor trainingTest of Movement Battery for children,DSM-5

Outcome Measures

Primary Outcomes (1)

  • THE DEVELOPMENTAL COORDINATION The Developmental Coordination Disorder Questionnaire

    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 Outcomes (1)

  • Short Sensory Profile

    2-5 hours

Study Arms (2)

Individual ASD Children

EXPERIMENTAL

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

Group of ASD Children

EXPERIMENTAL

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

Interventions

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.

Group of ASD Children

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.

Individual ASD Children

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University,

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sara Sattar, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It will be randomized control trial in which non probability convenient sampling will be used. Two groups of 4-12 age will be formed in which participants will be randomly divided. Group A: individually SPM training will be given, Group B: Grouped SPM training given
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 28, 2024

Study Start

September 26, 2024

Primary Completion

January 15, 2025

Study Completion

January 20, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations