DivingNCT06902168
Effect of Diving and Aquatic Exercises on Muscle Spasticity and Motor Function in Children With Spastic Cerebral Palsy
A study testing Intensive swimming program in people with Diving and Aquatic, run by Benha University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of diving and aquatic exercises on muscle spasticity and motor function in children with spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Diving, Aquatic, Muscle Spasticity
- What is being tested?
- Intensive swimming program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Mar 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 2 to 5 years.
- Both sexes.
- Children diagnosed with spastic cerebral palsy, categorized according to the Gross motor function classification system (GMFCS) levels IV, V.
Who cannot join
- Botulinum toxin treatment or surgery in the preceding three months.
- Botox injections before or during the application of the program.
- Dorsal rhizotomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Benha University (faculty of physical education)
Banhā, Benha, 13518
Sarah K Banawi, PhD, 00201274908934, sarakotb321@gmail.com
About this study
This study aims to evaluate the effect of diving and aquatic exercises on muscle spasticity and motor function in children with spastic cerebral palsy.
Read the detailed description
Cerebral palsy (CP) is a common neurological disorders that affect movement and muscle coordination in childhood. Hydrotherapy is one of the most popular supplementary treatments for children with neuro-motor impairments, particularly children with CP.
Hydrotherapy may be more suitable for children with CP because of the properties of water, and it may be more motivating for children than land-based exercise. Buoyancy makes it easier for children with moderate to severe mobility limitations to move in the water than to move and exercise on land.
- Conditions
- Diving, Aquatic, Muscle Spasticity, Motor Function, Children, Spastic Cerebral Palsy
- Being tested
- Intensive swimming program
- Medical subject headings
- Muscle Spasticity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive swimming programOther
The participants will be enrolled in an intensive swimming program for 8 weeks (45 minutes) in the swimming pool. The swimming program will be to improve safety and functional independence in the water. The hydrotherapy will be performed at a swimming pool temperature suitable for the weather temperature.
| Study group | Role | What they receive |
|---|---|---|
| Intensive swimming program | Experimental | The participants will be enrolled in an intensive swimming program for 8 weeks (45 minutes) in the swimming pool. The swimming program will be to improve safety and functional independence in the water. The hydrotherapy will be performed at a swimming pool temperature suitable for the weather temperature. Receives: Other: Intensive swimming program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor function measurement-66
The gross motor function measurement-66 (GMFM-66) employs a four-point scoring system for each item. The 66 items are recorded according to the following classification: 0 = child unable to initiate the task; 1 = child initiates the task; 2 = child partially completes the task; 3 = child completes the task; and NT = not tested.
Measured: 8 weeks after intensive swimming program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start29 Mar 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DivingStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Kotb Banawi, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902168
- Sponsor's protocol ID
- RC 4-2-2025
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diving and Aquatic Exercises on Muscle Spasticity and Motor Function in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06902168
- Acronym / sponsor ID
- RC 4-2-2025
- Conditions
- Diving, Aquatic, Muscle Spasticity, Motor Function, Children, Spastic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 30 Mar 2025 (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.
This study aims to evaluate the effect of diving and aquatic exercises on muscle spasticity and motor function in children with spastic cerebral palsy.
Detailed description
Cerebral palsy (CP) is a common neurological disorders that affect movement and muscle coordination in childhood. Hydrotherapy is one of the most popular supplementary treatments for children with neuro-motor impairments, particularly children with CP.
Hydrotherapy may be more suitable for children with CP because of the properties of water, and it may be more motivating for children than land-based exercise. Buoyancy makes it easier for children with moderate to severe mobility limitations to move in the water than to move and exercise on land.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive swimming program | Experimental | Other: Intensive swimming programThe participants will be enrolled in an intensive swimming program for 8 weeks (45 minutes) in the swimming pool. The swimming program will be to improve safety and functional independence in the water. The hydrotherapy will be performed at a swimming pool temperature suitable for the weather temperature. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from 2 to 5 years.
- Both sexes.
- Children diagnosed with spastic cerebral palsy, categorized according to the Gross motor function classification system (GMFCS) levels IV, V.
Key exclusion criteria (3 listed)
- Botulinum toxin treatment or surgery in the preceding three months.
- Botox injections before or during the application of the program.
- Dorsal rhizotomy.
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 |
|---|---|---|
| Intensive swimming programThe participants will be enrolled in an intensive swimming program for 8 weeks (45 minutes) in the swimming pool. The swimming program will be to improve safety and functional independence in the water. The hydrotherapy will be performed at a swimming pool temperature suitable for the weather temperature. | Other | Intensive swimming program |
Primary outcome
Gross motor function measurement-66
Time frame: 8 weeks after intensive swimming program
The gross motor function measurement-66 (GMFM-66) employs a four-point scoring system for each item. The 66 items are recorded according to the following classification: 0 = child unable to initiate the task; 1 = child initiates the task; 2 = child partially completes the task; 3 = child completes the task; and NT = not tested.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive swimming program in people with Diving and Aquatic, run by Benha 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah K Banawi, PhD (00201274908934, sarakotb321@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross motor function measurement-66 (time frame: 8 weeks after intensive swimming program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.