Effects of Hydrotherapy in Children With Cerebral Palsy

Evaluation of the Effects of Hydrotherapy on Balance and Selective Motor Control in Children With Cerebral Palsy

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy Children
• Intervention / Treatment: Other: Intervention Group (water-based and conventional exercise); Other: control group (conventional exercise)

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melis Gökçe Dağbağ Sağlam; Phone Number: +90 5362602519; Email: melisiel15@gmail.com
• Study Contact Backup: Name: Serap Seringeç Karabulut; Phone Number: +90 5057242669; Email: serapseringec@hotmail.com

Study Locations

• Turkey
  • Gaziosmanpasa
    • Istanbul, Gaziosmanpasa, Turkey, 34255
      • Recruiting
      • GaziosmanpasaTREH
      • Contact: Serap Seringeç Karabulut; Phone Number: +90 5057242669; Email: serapseringec@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Other: Intervention Group (water-based and conventional exercise); 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.
Active Comparator: Control Group; 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.	Other: control group (conventional exercise); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Balance Scale	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.	six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Selective Control of Upper Extremity Scale (SCUES)	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.	six weeks
Selective Control Assessment of the Lower Extremity (SCALE)	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.	six weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goal Attainment Scaling (GAS)	Goal Attainment Scaling is a method of scoring the extent to which patient's individual goals are achieved in the course of intervention. In effect, each patient has their own outcome measure but this is scored in a standardised way as to allow statistical analysis.	six weeks
Pediatric Quality of Life Inventory (PedsQL).	Pediatric Quality of Life Inventory is a standardized tool designed to measure health-related quality of life (HRQoL) in children and adolescents. It assesses the physical, emotional, social, and school functioning of children with various health conditions, including cerebral palsy.	six weeks
Child and Adolescent Scale of Participation (CASP).	Child and Adolescent Scale of Participation is a standardized assessment tool used to measure the extent of participation of children and adolescents in daily life activities across various settings, such as home, school, and community. It is particularly useful for children with disabilities or developmental disorders, including cerebral palsy.	six weeks
Pediatric Functional Independence Measure (WeeFIM)	Pediatric Functional Independence Measure is a standardized tool used to assess functional independence in children with disabilities, including cerebral palsy. It evaluates a child's ability to perform daily activities and tracks their level of assistance required in different domains.	six weeks
Gross Motor Function Classification System (GMFCS)	The Gross Motor Function Classification System is a standardized tool used to classify gross motor function in children and adolescents with cerebral palsy. It categorizes mobility levels based on self-initiated movement, need for assistive devices, and functional limitations.	six weeks
Gross Motor Function Measure (GMFM-88)	The Gross Motor Function Measure is a standardized clinical tool used to assess gross motor function in children with cerebral palsy and other motor impairments. It evaluates changes in motor abilities over time and helps guide rehabilitation planning.	six weeks

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Study Director: Ebru Yılmaz Yalçınkaya, Gaziosmanpasa Research and Education Hospital

Publications and helpful links

General Publications

• Roostaei M, Baharlouei H, Azadi H, Fragala-Pinkham MA. Effects of Aquatic Intervention on Gross Motor Skills in Children with Cerebral Palsy: A Systematic Review. Phys Occup Ther Pediatr. 2017 Oct 20;37(5):496-515. doi: 10.1080/01942638.2016.1247938. Epub 2016 Dec 14.
• Retarekar R, Fragala-Pinkham MA, Townsend EL. Effects of aquatic aerobic exercise for a child with cerebral palsy: single-subject design. Pediatr Phys Ther. 2009 Winter;21(4):336-44. doi: 10.1097/PEP.0b013e3181beb039.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: rehabilitation; cerebral palsy; balance; selective motor control; hydrotherapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: GaziosmanpasaTREH-FTR-MGDS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No