Effect of Oral Enteral Nutrition Feeding in Parkinson Disease

Muhammad

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Device: Intermittent Oro-esophageal Tube; Device: Nasogastric tube; Behavioral: Comprehensive rehabilitation training

Study type: Interventional

Funder types: Other

Identifiers

NCT06303947

IOE-PKS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 3.
• Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Intermittent Oro-esophageal Tube+comprehensive rehabilitation therapy

Experimental group

Description:

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

Treatment:

Device: Intermittent Oro-esophageal Tube

Behavioral: Comprehensive rehabilitation training

Nasogastric Tube+comprehensive rehabilitation therapy

Active Comparator group

Description:

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.

Treatment:

Device: Nasogastric tube

Behavioral: Comprehensive rehabilitation training