Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Rehabilitation Treatment Compliance Questionnaire
研究概览
简要总结
The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.
详细描述
The study will last 15 days for each participant. The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（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 of stroke;
- •any degree of dysphagia at admission;
- •steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
- •transferred out within three weeks of hospitalization in the neurology department.
排除标准
- •complicated with other neurological diseases;
- •damaged mucosa or incomplete structure in nasopharynx;
- •tracheostomy tube plugged;
- •unfeasible to the support of parenteral nutrition;
- •simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
研究组 & 干预措施
the observation group
The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists based on the condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups
干预措施: Intermittent Oro-esophageal Tube Feeding (Device)
the control group
the control group was given enteral nutritional support with Nasogastric Tube according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements.
干预措施: Nasogastric Tube Feeding (Device)
结局指标
主要结局
Rehabilitation Treatment Compliance Questionnaire
时间窗: day 1 and day 15
The Rehabilitation Treatment Compliance Questionnaire assesses patient compliance with rehabilitation treatment plans. It consists of 12 items that cover aspects such as the patient's understanding of the treatment plan, attitude towards treatment, compliance, and perception of rehabilitation outcomes. The scoring range for The Rehabilitation Treatment Compliance Questionnaire is typically from 12 to 60 points. A higher score indicates better understanding of the treatment plan, more positive attitude towards treatment, higher compliance with the treatment plan, and better perception of rehabilitation outcomes.
次要结局
- Patient Health Questionnaire-9(day 1 and day 15)
- Swallowing Quality of Life questionnaire(day 1 and day 15)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University