Spastik Hemiparetik Serebral Palsili Bireylerde Robotik Destekli Yürüyüş Eğitimi, Hidroterapi ve Konvansiyoel Fizyoterapi Yöntemlerinin Kas Kuvveti, Denge, Fonksiyonel Mobilite ve Ruhsal Uyum Üzerindeki Etkileri
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Muscle Strength
研究概览
简要总结
This study aims to evaluate the effects of three different physiotherapy approaches-robot-assisted gait training, hydrotherapy, and conventional physiotherapy-on muscle strength, balance, functional mobility, and psychological adjustment in children diagnosed with spastic hemiparetic cerebral palsy. A total of 45 ambulatory children aged 5 to 15 years will be randomly assigned to one of the three intervention groups. All participants will receive therapy twice a week for six weeks.
Muscle strength will be assessed using a handheld dynamometer, balance with the Pediatric Balance Scale, mobility with the Timed Up and Go test, and psychological adjustment with a standardized behavioral checklist. The study will help determine which therapeutic approach provides the most benefit in improving physical function and emotional well-being. Results may guide healthcare providers and families in selecting the most effective rehabilitation method for children with cerebral palsy.
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
- None
盲法说明
No masking will be implemented in this study. All participants, care providers, investigators, and outcome assessors will be aware of the assigned interventions due to the nature of the treatment protocols.
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 5 and 15 years
- •Diagnosed with spastic hemiparetic cerebral palsy
- •Classified as Level I or II on the Gross Motor Function Classification System (GMFCS)
- •Able to follow simple instructions and participate in therapy sessions
- •Written informed consent obtained from parents or legal guardians
排除标准
- •Severe cognitive or mental impairment that interferes with communication
- •Lower extremity joint contractures preventing use of robotic gait device
- •Uncontrolled cardiac disease
- •Active infection at the time of intervention
- •Open skin lesions on the legs or trunk
- •Inability to properly fit orthoses required for therapy
- •Withdrawal of consent by the child or parent/guardian
- •Failure to complete the assessment tests
- •New illness or surgical intervention during the study period
结局指标
主要结局
Muscle Strength
时间窗: Baseline and Week 6
Change in lower extremity muscle strength measured by hand-held dynamometer (MicroFET® 2) at baseline and after 6 weeks of intervention.
Balance
时间窗: Baseline and Week 6
Change in balance performance assessed by Pediatric Balance Scale (PBS).
Functional Mobility
时间窗: Baseline and Week 6
Change in mobility measured using the Timed Up and Go (TUG) test.
次要结局
- Treatment Tolerance and Adherence(Ongoing through 6 weeks)
- Psychological Adjustment(Baseline and Week 6)
研究者
Ozge Baykan Copuroglu
Asst. Prof.
Istanbul Arel University