- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07669350
Effect of Aquatic Therapy Program on Balance in Children With Spastic Diplegic Cerebral Palsy
June 20, 2026 updated by: Ibrahim Ahmed Ibrahim Abu Ella, Delta University for Science and Technology
- Evaluate the effect of a structured aquatic therapy programme on static balance in children with spastic diplegic cerebral palsy.
- Assess the effect of the same programme on dynamic balance in this patient population.
- Compare balance outcomes between children receiving aquatic therapy and those receiving conventional land-based physiotherapy.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Cerebral palsy (CP) is the most common cause of permanent motor disability in childhood, with spastic diplegia being the most prevalent subtype, characterized by bilateral lower limb spasticity, impaired postural control, and significantly compromised balance - deficits that restrict functional mobility and participation in daily activities.
These balance impairments arise from disrupted selective motor control, abnormal muscle tone, reduced proprioceptive integration, and impaired neuromuscular coordination, and represent a central therapeutic target in paediatric rehabilitation.
Aquatic therapy exploits the physical properties of water - buoyancy, hydrostatic pressure, warmth, and viscosity - to reduce spasticity, facilitate movement, and promote motor learning in a safe environment, with meta-analytic evidence confirming significant improvements in gross motor function compared to land-based approaches.
However, studies specifically targeting balance as a primary outcome in children with spastic diplegic CP remain limited, representing a clinically important gap that this study seeks to address.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ibrahim A abu ella, Phd
- Phone Number: +201008442281
- Email: ibrahimneuron@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Confirmed diagnosis of spastic diplegic cerebral palsy by a paediatric neurologist or developmental paediatrician
- Age between 5 and 12 years
- Classified at GMFCS levels I-III
- Bilateral lower limb spasticity with a Modified Ashworth Scale (MAS) score of ≥ 1
Exclusion Criteria:
- Athetoid, ataxic, or mixed-type cerebral palsy
- GMFCS levels IV or V (non-ambulatory children)
- Uncontrolled seizure disorder or epilepsy not managed by medication
- Open wounds, skin infections, or active dermatological conditions contraindicating water immersion
- Fear of water (aquaphobia) or inability to tolerate the aquatic environment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study group
study group will receive aquatic exercise therapy
|
Aquatic therapy is a specialized rehabilitation approach that utilizes the physical properties of water, including buoyancy, hydrostatic pressure, and resistance, to facilitate movement and improve functional performance in children with diplegic cerebral palsy.
The aquatic environment reduces weight-bearing demands, allowing safer practice of balance, gait, strength, and motor control activities while minimizing joint stress.
Regular aquatic therapy may enhance muscle strength, postural stability, mobility, and overall participation in daily activities.
|
|
Active Comparator: control group
land exercise program
|
The control group participated in a conventional land-based exercise program consisting of stretching, strengthening, balance, and functional mobility exercises.
The program focused on improving lower-extremity muscle strength, postural control, gait performance, and overall functional abilities through activities performed on a stable surface.
Exercises were progressed according to each participant's abilities while maintaining consistency in treatment duration and frequency across the study groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
static balance
Time Frame: baseline
|
Static and dynamic balance will be assessed using the Biodex Balance System.
Stability indices will be recorded to evaluate postural control and balance performance
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 25, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 15, 2026
Study Registration Dates
First Submitted
June 20, 2026
First Submitted That Met QC Criteria
June 20, 2026
First Posted (Actual)
June 25, 2026
Study Record Updates
Last Update Posted (Actual)
June 25, 2026
Last Update Submitted That Met QC Criteria
June 20, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- trial CP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
confidentiality of the research
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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