Autism Spectrum DisorderNCT05123066
Effect of Aquatic Training on Motor Function in Children With Autism Spectrum Disorder
A study testing Aquatic Exercises and Land Exercises in people with Autism Spectrum Disorder, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Aquatic Exercises and Land Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranges from 3 to 5 years.
- Mild to moderate autistic features according to GARS (scores from 60 to 110).
Who cannot join
- Significant visual or auditory defects.
- History of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder).
- Open wound.
- Dermatological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aquatic Training Versus Land Exercises on Motor Function in Children With Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Aquatic Exercises, Land Exercises
- Keywords
- Autism Spectrum Disorder, Aquatic Therapy, Motor development, Land Exercises
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic ExercisesOther
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.
Land ExercisesOther
All participants were physical therapy intervention according to their level of functional impairment :
| Study group | Role | What they receive |
|---|---|---|
| Aquatic group | Experimental | group I Receives: Other: Aquatic Exercises |
| Land Exersises group | Experimental | group II Receives: Other: Land Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- = 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
Measured: 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
Measured: Treatment for 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Jan 2023
- Primary completion16 Aug 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Abd-elmonem, Cairo University
- Investigators
- Amira M ABD-ELMONEM, PhD, Study chair, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo UniversityMAI E ABBASS, PhD, Study director, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo UniversityAMR A OTHMAN, PhD, Study director, Pediatrics Department, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123066
- Sponsor's protocol ID
- AQUATIC TRAINING
- Status last verified
- Dec 2022
- First submitted
- 5 Nov 2021
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Albadry ES, Ibrahim NM, Othman AA, Abd-Elmonem AM, Abbass ME. Effect of Aquatic Training Versus Land Exercises on Motor Function in Children With Autism Spectrum Disorder: A Randomized Controlled Trial. Physiother Res Int. 2026 Apr;31(2):e70220. doi: 10.1002/pri.70220.
PubMed 41988871
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aquatic Training Versus Land Exercises on Motor Function in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05123066
- Acronym / sponsor ID
- AQUATIC TRAINING
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Aquatic Therapy, Motor development, Land Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic group | Experimental | Other: Aquatic Exercisesgroup I |
| Land Exersises group | Experimental | Other: Land Exercisesgroup II |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age ranges from 3 to 5 years.
- Mild to moderate autistic features according to GARS (scores from 60 to 110).
Key exclusion criteria (4 listed)
- Significant visual or auditory defects.
- History of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder).
- Open wound.
- Dermatological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic ExercisesThese 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. | Other | Aquatic group |
| Land ExercisesAll participants were physical therapy intervention according to their level of functional impairment : | Other | Land Exersises group |
Primary outcome
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
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 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Derived from this study: PubMed 41988871Albadry ES, Ibrahim NM, Othman AA, Abd-Elmonem AM, Abbass ME. Effect of Aquatic Training Versus Land Exercises on Motor Function in Children With Autism Spectrum Disorder: A Randomized Controlled Trial. Physiother Res Int. 2026 Apr;31(2):e70220. doi: 10.1002/pri.70220.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira M ABD-ELMONEM, PhD study chair
Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
MAI E ABBASS, PhD study director
Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
AMR A OTHMAN, PhD study director
Pediatrics Department, Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Exercises and Land Exercises in people with Autism Spectrum Disorder, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Index (time frame: Treatment for 3 monthes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05123066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.