Evaluation of the Effects of Hydrotherapy on Balance and Selective Motor Control in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pediatric Balance Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Intervention Group (water-based and conventional exercise) (Other)
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.
干预措施: control group (conventional exercise) (Other)
结局指标
主要结局
Pediatric Balance Scale
时间窗: 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.
次要结局
- Selective Control of Upper Extremity Scale (SCUES)(six weeks)
- Selective Control Assessment of the Lower Extremity (SCALE)(six weeks)
研究者
Melis Gökçe Dağbağ
Medical Doctor
Gaziosmanpasa Research and Education Hospital