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Clinical Trials/NCT06393218
NCT06393218
Not yet recruiting
Not Applicable

The Impact of Diaphragm Training on Dysphagia in Bulbar Palsy After Ischemic Stroke: A Randomized Controlled Study

Copka Sonpashan0 sites100 target enrollmentApril 2024
ConditionsBulbar Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bulbar Palsy
Sponsor
Copka Sonpashan
Enrollment
100
Primary Endpoint
Penetration-Aspiration Scale
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding. The observation group will be given Diaphragm Training Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Detailed Description

Dysphagia in patients after stroke continues to be a challenge. This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding. The observation group will be given Diaphragm Training Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Registry
clinicaltrials.gov
Start Date
April 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

Research Director

Chao Phya Abhaibhubejhr Hospital

Eligibility Criteria

Inclusion Criteria

  • age ≥ 18 years;
  • meeting the diagnostic criteria of Bulbar Palsy After Ischemic Stroke;
  • any degree of dysphagia at admission;
  • steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
  • clear mind.

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

Penetration-Aspiration Scale

Time Frame: Day 1 and day 15

The Penetration-Aspiration Scale was conducted under video fluoroscopic swallowing study. The scale is a standardized tool used to assess the safety of swallowing. The scale was developed to evaluate the entry of material into the airway (penetration) and the subsequent passage of material below the vocal folds (aspiration) during swallowing. The scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration.

Secondary Outcomes

  • Functional Oral Intake Scale(Day 1 and day 15)
  • Dysphagia Handicap Index(Day 1 and day 15)

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