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Clinical Trials/NCT06328920
NCT06328920
Not Yet Recruiting
N/A

A Randomized Controlled Study to Explore the Effect of Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients

Copka Sonpashan0 sites80 target enrollmentMarch 2024
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Copka Sonpashan
Enrollment
80
Primary Endpoint
Rehabilitation Treatment Compliance Questionnaire
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

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 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Rehabilitation Treatment Compliance Questionnaire

Time Frame: 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.

Secondary Outcomes

  • Patient Health Questionnaire-9(day 1 and day 15)
  • Swallowing Quality of Life questionnaire(day 1 and day 15)

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