Effect of Diving and Aquatic Exercises on Muscle Spasticity and Motor Function in Children With Spastic Cerebral Palsy

March 29, 2025 updated by: Sarah Kotb Banawi, Benha University
This study aims to evaluate the effect of diving and aquatic exercises on muscle spasticity and motor function in children with spastic cerebral palsy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

37

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

Study Locations

  • Egypt
    • Benha
      • Banhā, Benha, Egypt, 13518
        • Recruiting
        • Benha University (faculty of physical education)
        • Contact:

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:

  • 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.

Exclusion Criteria:

  • Botulinum toxin treatment or surgery in the preceding three months.
  • Botox injections before or during the application of the program.
  • Dorsal rhizotomy.

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive swimming program
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.
Other: Intensive swimming program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks after intensive swimming program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

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 (Actual)

March 29, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 29, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 4-2-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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