A Randomized Trial to Explore the Effect of Oral Enteral Nutrition Feeding in Parkinson Disease
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
- Serum albumin level
研究概览
简要总结
The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:
• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.
Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.
详细描述
Nasogastric tube feeding has been widely used in patients with Parkinson's disease but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy.
The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:
• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.
Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years.
- •Meeting the diagnostic criteria for Parkinson's disease.
- •Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
- •Water swallow test> Level
- •Stable vital signs, conscious, able to cooperate with assessment and treatment.
排除标准
- •Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
- •Complicated with cognitive impairment or consciousness dysfunction.
- •Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
- •Complicated with severe liver and kidney failure, tumors, or hematological disorders.
研究组 & 干预措施
Intermittent Oro-esophageal Tube+comprehensive rehabilitation therapy
Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows:
Basic treatment, including corresponding control of risk factors and education on healthy lifestyles.
Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
The group was given enteral nutritional support with Intermittent Oro-esophageal Tube Feeding
干预措施: Intermittent Oro-esophageal Tube (Device)
Intermittent Oro-esophageal Tube+comprehensive rehabilitation therapy
Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows:
Basic treatment, including corresponding control of risk factors and education on healthy lifestyles.
Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
The group was given enteral nutritional support with Intermittent Oro-esophageal Tube Feeding
干预措施: Comprehensive rehabilitation training (Behavioral)
Nasogastric Tube+comprehensive rehabilitation therapy
Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows:
Basic treatment, including corresponding control of risk factors and education on healthy lifestyles.
Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
Besides, the group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines.
干预措施: Nasogastric tube (Device)
Nasogastric Tube+comprehensive rehabilitation therapy
Assigned by the random number table. During the treatment, all patients were provided with comprehensive rehabilitation therapy as follows:
Basic treatment, including corresponding control of risk factors and education on healthy lifestyles.
Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
Besides, the group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines.
干预措施: Comprehensive rehabilitation training (Behavioral)
结局指标
主要结局
Serum albumin level
时间窗: day 1 and day 15
Serum albumin was recorded via blood routine test.(Alb, g/L)
Hemoglobin
时间窗: day 1 and day 15
Hemoglobin was recorded via blood routine test.(Hb, mg/L)
次要结局
- Modified Barthel Index(day 1 and day 15)
- Functional Oral Intake Scale(day 1 and day 15)
研究者
Muhammad
Research Director
Ahmadu Bello University Teaching Hospital