Effects of Hydrotherapy in Children With Cerebral Palsy

NCT06899035 | Recruiting

• 1 other identifier: GaziosmanpasaTREH-FTR-MGDS-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy Children

Keywords

hydrotherapy; rehabilitation; balance; selective motor control; cerebral palsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Selective Control of Upper Extremity Scale (SCUES)

  six weeks

• Selective Control Assessment of the Lower Extremity (SCALE)

  six weeks

Other Outcomes (6)

• Goal Attainment Scaling (GAS)

  six weeks

• Pediatric Quality of Life Inventory (PedsQL).

  six weeks

• Child and Adolescent Scale of Participation (CASP).

  six weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)

Control Group

ACTIVE COMPARATOR

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)

Interventions

Intervention Group (water-based and conventional exercise) OTHER

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.

Intervention Group

control group (conventional exercise) OTHER

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.

Control Group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

GaziosmanpasaTREH

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 27967298 BACKGROUND

• 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.

  PMID: 19923974 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ebru Yılmaz Yalçınkaya

  Gaziosmanpasa Research and Education Hospital

  STUDY DIRECTOR

Central Study Contacts

Melis Gökçe Dağbağ Sağlam

CONTACT

5362602519; melisiel15@gmail.com

Serap Seringeç Karabulut

CONTACT

5057242669; serapseringec@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single blind study, the control group will receive a home exercise program, while the intervention group will receive both a home exercise program and hydrotherapy. Outcome assessments will be conducted by an investigator who is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: two groups: an intervention group and a control group

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 27, 2025
• Study Start: January 22, 2025
• Primary Completion: September 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)