NCT06902168

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

March 29, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 22, 2025

Last Update Submit

March 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks after intensive swimming program

Study Arms (1)

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.

Other: Intensive swimming program

Interventions

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.

Intensive swimming program

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University (faculty of physical education)

Banhā, Benha, 13518, Egypt

RECRUITING

MeSH Terms

Conditions

Muscle SpasticityCerebral Palsy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Central Study Contacts

Sarah K Banawi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD in Philosophy, Faculty of Physical Education, Benha University, Egypt.

Study Record Dates

First Submitted

March 22, 2025

First Posted

March 30, 2025

Study Start

March 29, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations