Effect of Intermittent Oro-esophageal Tube Feeding on Dysphagic Patients With Parkinson Disease
- Conditions
- Parkinson Disease
- Interventions
- Device: Nasogastric tubeDevice: Intermittent Oro-esophageal TubeBehavioral: Comprehensive rehabilitation training
- Registration Number
- NCT06206122
- Lead Sponsor
- Zeng Changhao
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age >18 years.
- Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.
- Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
- Water swallow test> Level 3.
- Stable vital signs, conscious, able to cooperate with assessment and treatment.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The control group Nasogastric tube 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 control group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines. The observation group Comprehensive rehabilitation training 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 observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube Feeding The observation group Intermittent Oro-esophageal Tube 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 observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube Feeding The control group Comprehensive rehabilitation training 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 control group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines.
- Primary Outcome Measures
Name Time Method Video Fluoroscopic Swallowing Study day 1 and day 15 Video Fluoroscopic Swallowing Study, which is considered as the "gold standard", swallowing process is divided into four periods: cognitive, oral, pharyngeal, and esophageal periods with a total score of 10 and a higher score indicates better swallowing ability (less dysphagia).
- Secondary Outcome Measures
Name Time Method Serum albumin day 1 and day 15 Serum albumin was recorded via blood routine test.(Alb, g/L)
Hemoglobin day 1 and day 15 Hemoglobin was recorded via blood routine test.(Hb, mg/L)
Modified Barthel Index day 1 and day 15 The activities of daily living was assessed utilizing the Modified Barthel Index (MBI). Modified Barthel Index includes the following 10 subscales. For each subscale, choices encoded with the score 10, 8, 5, 2, 0 are set with the decreasing level of self-dependence, while the final total is positively correlated with Activities of daily living. Cronbach's α of questionnaire adopted is 0.916.
Functional Oral Intake Scale day 1 and day 15 During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted.
Trial Locations
- Locations (1)
Zheng da yi fu yuan hospital
🇨🇳Zhengzhou, China