NCT05123066

Brief Summary

Clinically, infants with Autism Spectrum Disorder often display gross motor delays in supine, prone, and sitting skills in their first year of life . Studies reveal that motor abnormalities in Autism Spectrum Disorder can occur very early in developmental trajectory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2022

Enrollment Period

8 months

First QC Date

November 5, 2021

Last Update Submit

December 2, 2025

Conditions

Keywords

Autism Spectrum DisorderAquatic TherapyMotor developmentLand Exercises

Outcome Measures

Primary Outcomes (3)

  • Autism Index

    Gilliam autism rating scale: Items on the developmental subscale address behaviors and milestones in the first 36 months of life. Items on the first three behavioral subscales are rated on a four point like scale ranging from Never Observed (0) to Frequently Observed (3). After completing it, the examiner calculated the total raw scores then converted into scaled scores and percentile ranks according to the examiner's manual. Higher scaled scores on a subscale represent severe autistic behavior. Finally, the total scaled scores were calculated to measure the autism index according to the examiner's manual. The higher the autism index, the higher the probability the individual has autism and the more severe the autistic behavior

    Treatment for 3 monthes

  • Motor Development

    The Peabody Developmental Motor Scales-Second Edition: The gross motor function domain will be assessed in the current study. The gross motor function domains contain four subtests. Reflexes, Stationary ,Locomotion and Object Manipulation . Grading and Scoring of the PDMS-2 The therapist will ask the child to do a specific item and observes how the child is doing the task. Items are scored as 2, 1 or 0. 0 = child cannot or will not attempt an item or the attempt does not indicate that the specific skill is emerging 1. = child's performance shows a clear resemblance to item mastery criteria but does not fully meet the criteria or there are signs of an emerging skill 2. = child performs item according to the criteria specified for mastering the skill

    Treatment for 3 monthes

  • Pediatric Quality of life Inventory Scale

    Pediatric Quality of life Inventory Scale: The Arabic version will be used to assess quality of life. It contains questions about child's physical, emotional, social, and school functioning in the past 7 days. Parents/ child self-administered the quality of life after introductory instructions from the administrator. On the quality of life Generic Core Scales, for ease of interpretability, items are 22 reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related quality of Life. To reverse score, transform the 0-4 scale items to 0-100 as follows: 0-100, 1=75, 2= 50, 3= 25 and 4= 0. Finally, the Scale Score for each dimension and Total Scale Score were calculated

    Treatment for 3 monthes

Study Arms (2)

Aquatic group

EXPERIMENTAL

group I

Other: Aquatic Exercises

Land Exersises group

EXPERIMENTAL

group II

Other: Land Exercises

Interventions

All participants were physical therapy intervention according to their level of functional impairment :

Land Exersises group

These 3 sets were the following: Set 1: warming up exercise as floating exercise 24 Set 2: Standing education/training Set 3: Walking education/training The exercises will be conducted taking in consideration safety measures as: 1. Each participant will use Noodles to ensure safety. 2. Each participant will train individually to ensure safety and avoid distraction. 3. Each participant will use special swimming suit in case of lack of bowel and/or bladder control.

Aquatic group

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age ranges from 3 to 5 years.
  • Mild to moderate autistic features according to GARS (scores from 60 to 110).

You may not qualify if:

  • Significant visual or auditory defects.
  • History of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder).
  • Open wound.
  • Dermatological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eman S Albadry

Giza, Giza Governorate, 12662, Egypt

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Amira M ABD-ELMONEM, PhD

    Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University

    STUDY CHAIR
  • MAI E ABBASS, PhD

    Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University

    STUDY DIRECTOR
  • AMR A OTHMAN, PhD

    Pediatrics Department, Faculty of Medicine, Sohag University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
They will be allocated randomly into two groups of equal numbers, group I (the aquatic training group) and the group II (land exercises).
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof. physical therapy for pediatric department, faculty of physical therappy

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 17, 2021

Study Start

January 1, 2023

Primary Completion

August 16, 2023

Study Completion

October 20, 2023

Last Updated

December 8, 2025

Record last verified: 2022-12

Locations