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Clinical Trials/NCT06328881
NCT06328881
Not yet recruiting
Not Applicable

Effect of Intermittent Oral Tube on Dysphagia in Parkinson's Disease Patients: A Randomized Trial

Copka Sonpashan0 sites80 target enrollmentMarch 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Copka Sonpashan
Enrollment
80
Primary Endpoint
Concentration of Hemoglobin
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2024
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Copka Sonpashan
Responsible Party
Sponsor Investigator
Principal Investigator

Copka Sonpashan

The Research Director

Chao Phya Abhaibhubejhr Hospital

Eligibility Criteria

Inclusion Criteria

  • Age \>18 years.
  • Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in
  • 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.

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.

Outcomes

Primary Outcomes

Concentration of Hemoglobin

Time Frame: day 1 and day 15

Hemoglobin was recorded via blood routine test.(Hb, mg/L)

Concentration of Serum albumin

Time Frame: day 1 and day 15

Serum albumin was recorded via blood routine test.(Alb, g/L)

Secondary Outcomes

  • Modified Barthel Index(day 1 and day 15)
  • Functional Oral Intake Scale(day 1 and day 15)

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