Effect of Intermittent Oro-esophageal Tube Feeding on Dysphagic Patients With Parkinson Disease

Z

Zeng Changhao

Status

Withdrawn

Conditions

Parkinson Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06206122
2024-KY-0102-016

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

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

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

The observation group
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 observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube Feeding
Treatment:
Behavioral: Comprehensive rehabilitation training
Device: Intermittent Oro-esophageal Tube
The control group
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 control group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines.
Treatment:
Behavioral: Comprehensive rehabilitation training
Device: Nasogastric tube

Trial contacts and locations

1

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Central trial contact

Weiji Zhao, Master; Zhefeng Wang, Doctor

Data sourced from clinicaltrials.gov

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