Effects of Hydrotherapy in Children With Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Cerebral Palsy Children

• Registration Number: NCT06899035
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

The goal of this observational study is to learn the effects of hydrotherapy in children with cerebral palsy. It aims to answer if hydrotherapy is affective on balance and selective motor control of the children with cerebral palsy.

Detailed Description

Children diagnosed with cerebral palsy by a pediatric neurologist and followed up at the Pediatric Rehabilitation Outpatient Clinic of the Physical Medicine and Rehabilitation Department at Sağlık Bilimleri University Gaziosmanpaşa Training and Research Hospital, aged between 4 and 18 years, with a Gross Motor Function Classification System (GMFCS) level of 1-4, will be included in the study.

Patients scheduled for hydrotherapy treatment will be enrolled in the study. The participants will be randomly assigned into two groups using the envelope randomization method. The first group will be the study group, while the second group will be the control group. The control group will receive hydrotherapy after the study is completed.

Demographic data such as age, height, weight, and body mass index (BMI) of the included children will be recorded. Functional status will be assessed using the Gross Motor Function Classification System (GMFCS) and the Gross Motor Function Measure (GMFM-88) sections D and E. Balance will be evaluated with the Pediatric Balance Scale (PBS), selective motor control for upper and lower extremities with SCUES (Selective Control of Upper Extremity Scale) and SCALE (Selective Control Assessment of the Lower Extremity), activity with the Pediatric Functional Independence Measure (WeeFIM), participation with the Child and Adolescent Scale of Participation (CASP), quality of life with the Pediatric Quality of Life Inventory (PedsQL), and goal achievement with the Goal Attainment Scale (GAS).

Patients in the study group will undergo individualized water-based exercises (including standing, balance, weight shifting, breathing exercises, range of motion, stretching, and strengthening exercises) under the supervision of an experienced physiotherapist, 2-3 times per week for six weeks. Additionally, routine conventional exercises will be continued daily for six weeks.

Patients in the control group will continue passive, active, active-assisted, or resistance-based upper and lower extremity conventional exercises appropriate to their functional level and muscle strength. They will be instructed to perform these exercises 2-3 times per week, with each session lasting no more than 45 minutes, for six weeks.

Assessments conducted at the beginning of the study will be repeated at the end of six weeks and one month after the completion of the intervention. The results will be compared accordingly.

\* Conventional exercise therapy consists of range of motion, stretching, and strengthening exercises applied to patients diagnosed with cerebral palsy.

This is a single-center, single-blind, prospective clinical study. A total of 36 patients, including 18 in the study group and 18 in the control group, are planned to be included between January 1, 2024, and September 15, 2025.

Study Timeline

• Study Start: 2025-01-22
• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-09-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Diagnosed with Cerebral Palsy by a specialist physician
• Aged between 4-18 years
• Cooperative with physiotherapy applications
• Gross Motor Function Classification System (GMFCS) levels 1-4
• Willing to participate in the study and undergo assessments

Exclusion Criteria

• Mental retardation or insufficient cognitive function to comply with study assessments
• GMFCS level 5
• Presence of an intrathecal baclofen pump for spasticity treatment or history of soft tissue and/or bone surgery
• Active infection or localized skin infection at the injection site
• History of active seizures
• Presence of contractures
• Serious systemic disease that may prevent exercise participation
• Injury and/or surgery within the last 6 months
• Botulinum toxin injection within the last 6 months
• Contraindications to hydrotherapy, including severe fear of water, behavioral problems, shortness of breath at rest, infection, incontinence, known chlorine allergy, open wounds, acute systemic illness, epilepsy, tracheostomy, permanent drains, immunodeficiency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pediatric Balance Scale	six weeks	The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills during tasks that mimic experiences of everyday living in school-aged children. The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

Secondary Outcome Measures

Name	Time	Method
Selective Control of Upper Extremity Scale (SCUES)	six weeks	Selective Control of Upper Extremity Scale is a clinical assessment tool used to evaluate selective motor control (SMC) in the upper extremities of individuals with neurological impairments, such as cerebral palsy. It is adapted from the Selective Control Assessment of the Lower Extremity (SCALE) and focuses on assessing isolated joint movements in the shoulder, elbow, forearm, wrist, and fingers while minimizing synergistic patterns or involuntary movements.
Selective Control Assessment of the Lower Extremity (SCALE)	six weeks	Selective Control Assessment of the Lower Extremity is a clinical tool used to evaluate selective voluntary motor control (SVMC) in individuals with neuromotor disorders, such as cerebral palsy. It assesses the ability to perform isolated joint movements in the lower extremities without involuntary movements or abnormal muscle synergies.

Trial Locations

Locations (1)

GaziosmanpasaTREH; 🇹🇷 Istanbul, Gaziosmanpasa, Turkey