- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05123066
Effect of Aquatic Training on Motor Function in Children With Autism Spectrum Disorder
Effect of Aquatic Training Versus Land Exercises on Motor Function in Children With Autism Spectrum Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eman S Albadry, Master
- Phone Number: 01016536369
- Email: monyalbadry12@gmail.com
Study Locations
-
-
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Giza, Egypt, 12662
- Recruiting
- Eman S Albadry
-
Contact:
- Eman S Albadry, Master
- Phone Number: 01016536369
- Email: monyalbadry12@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ranges from 3 to 5 years.
- Mild to moderate autistic features according to GARS (scores from 60 to 110).
Exclusion Criteria:
- Significant visual or auditory defects.
- History of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder).
- Open wound.
- Dermatological diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aquatic group
group I
|
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:
|
Experimental: Land Exersises group
group II
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All participants were physical therapy intervention according to their level of functional impairment :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autism Index
Time Frame: Treatment for 3 monthes
|
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
Time Frame: Treatment for 3 monthes
|
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
|
Treatment for 3 monthes
|
Pediatric Quality of life Inventory Scale
Time Frame: Treatment for 3 monthes
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amira M ABD-ELMONEM, PhD, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
- Study Director: 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AQUATIC TRAINING
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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