Back to resultsEffect of Aquatic Training on Motor Function in Children With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aquatic Exercises
Land Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Aquatic Therapy, Motor development, Land Exercises
Eligibility Criteria
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
Sites / Locations
- Eman S AlbadryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Aquatic group
Land Exersises group
Arm Description
group I
group II
Outcomes
Primary Outcome Measures
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
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
= 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
= child performs item according to the criteria specified for mastering the skill
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05123066
Brief Title
Effect of Aquatic Training on Motor Function in Children With Autism Spectrum Disorder
Official Title
Effect of Aquatic Training Versus Land Exercises on Motor Function in Children With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Hydrotherapy is an environment that may be conducive to encouraging physical activity in children with Autism Spectrum Disorder. The buoyancy of water can assist with movement, balance, and coordination .Water also provides an opportunity for social interaction through aquatic games and activities.Based on the literature, Aquatic therapy appears to be particularly beneficial for children with Autism Spectrum Disorder who need strong sensory stimulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, Aquatic Therapy, Motor development, Land Exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
They will be allocated randomly into two groups of equal numbers, group I (the aquatic training group) and the group II (land exercises).
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aquatic group
Arm Type
Experimental
Arm Description
group I
Arm Title
Land Exersises group
Arm Type
Experimental
Arm Description
group II
Intervention Type
Other
Intervention Name(s)
Aquatic Exercises
Intervention Description
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:
Each participant will use Noodles to ensure safety.
Each participant will train individually to ensure safety and avoid distraction.
Each participant will use special swimming suit in case of lack of bowel and/or bladder control.
Intervention Type
Other
Intervention Name(s)
Land Exercises
Intervention Description
All participants were physical therapy intervention according to their level of functional impairment :
Primary Outcome Measure Information:
Title
Autism Index
Description
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
Time Frame
Treatment for 3 monthes
Title
Motor Development
Description
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
= 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
= child performs item according to the criteria specified for mastering the skill
Time Frame
Treatment for 3 monthes
Title
Pediatric Quality of life Inventory Scale
Description
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
Time Frame
Treatment for 3 monthes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman S Albadry, Master
Phone
01016536369
Email
monyalbadry12@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira M ABD-ELMONEM, PhD
Organizational Affiliation
Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
MAI E ABBASS, PhD
Organizational Affiliation
Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
AMR A OTHMAN, PhD
Organizational Affiliation
Pediatrics Department, Faculty of Medicine, Sohag University
Official's Role
Study Director
Facility Information:
Facility Name
Eman S Albadry
City
Giza
ZIP/Postal Code
12662
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman S Albadry, Master
Phone
01016536369
Email
monyalbadry12@gmail.com
12. IPD Sharing Statement
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Effect of Aquatic Training on Motor Function in Children With Autism Spectrum Disorder
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