Clinical trial NCT06899035: Effects of Hydrotherapy in Children With Cerebral Palsy
Official title: Evaluation of the Effects of Hydrotherapy on Balance and Selective Motor Control in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy Children
Keywords: hydrotherapy
rehabilitation
balance
selective motor control
cerebral palsy
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-27
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups: an intervention group and a control group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pediatric Balance Scale
timeFrame: six weeks
Secondary outcomes:
measure: Selective Control of Upper Extremity Scale (SCUES)
timeFrame: six weeks
measure: Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: six weeks
Other outcomes:
measure: Goal Attainment Scaling (GAS)
timeFrame: six weeks
measure: Pediatric Quality of Life Inventory (PedsQL).
timeFrame: six weeks
measure: Child and Adolescent Scale of Participation (CASP).
timeFrame: six weeks
measure: Pediatric Functional Independence Measure (WeeFIM)
timeFrame: six weeks
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: six weeks
measure: Gross Motor Function Measure (GMFM-88)
timeFrame: six weeks
Locations:
city: Istanbul
country: Turkey
facility: GaziosmanpasaTREH
state: Gaziosmanpasa
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: Ebru Yılmaz Yalçınkaya
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.