A Randomized Controlled Study to Explore The Effect of Stellate Ganglion Block in Cerebral Palsy and Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Penetration-Aspiration Scale
研究概览
简要总结
The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:
• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.
详细描述
Cerebral palsy is a common non-progressive clinical condition characterized by motor disorders and abnormal postures, which significantly impact the quality of life of affected children. Swallowing dysfunction is a common complication in children with Cerebral palsy , affecting their daily eating and communication skills, and hindering their nutritional development and social interaction. Stellate ganglion block has shown certain efficacy in improving swallowing function in children with Cerebral palsy. However, there is limited research on the effects of stellate ganglion block treatment on swallowing dysfunction in children with Cerebral palsy. Therefore, this study aims to explore this topic and provide scientific evidence for its clinical application.
The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:
• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation;
- •age between 4 to 7 years;
- •diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy;
排除标准
- •with dysphagia caused by other diseases or factors;
- •with progressive neurological disease or degenerative neurological disease;
- •with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms;
- •with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract;
- •with poor compliance.
研究组 & 干预措施
routine rehabilitation treatment+Stellate ganglion block
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.The experimental group was given Stellate Ganglion Block.
干预措施: routine rehabilitation treatment (Behavioral)
routine rehabilitation treatment+Stellate ganglion block
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.The experimental group was given Stellate Ganglion Block.
干预措施: Stellate ganglion block (Procedure)
routine rehabilitation treatment+Stellate ganglion block
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.The experimental group was given Stellate Ganglion Block.
干预措施: Lidocaine hydrochloride (Drug)
routine rehabilitation treatment+Placebo
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.
干预措施: routine rehabilitation treatment (Behavioral)
routine rehabilitation treatment+Placebo
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.
干预措施: Placebo injection (Procedure)
结局指标
主要结局
Penetration-Aspiration Scale
时间窗: day 1 and day 10
Penetration-Aspiration Scale is used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food enter the airway and caused penetration or aspiration during the swallowing process. As the level increases, the severity of dysphagia also increases. The scale scores range between 1 and 8.
次要结局
- Functional Oral Intake Scale(day 1 and day 10)
- Swallowing duration(day 1 and day 10)
研究者
Copka Sonpashan
Research Director
Chao Phya Abhaibhubejhr Hospital