The Impact of Diaphragm Training on Dysphagia in Bulbar Palsy After Ischemic Stroke

Not Applicable

Not yet recruiting

• Conditions: Bulbar Palsy
• Interventions: Device: Intermittent Oro-esophageal Tube Feeding; Behavioral: Routine rehabilitation; Behavioral: Diaphragm Training

• Registration Number: NCT06393218
• Lead Sponsor: Copka Sonpashan

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.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04
• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-04-27
• Last Update Submitted: 2024-04-27
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine rehabilitation	Routine rehabilitation	Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The observation group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding.
Routine rehabilitation+Diaphragm Training	Intermittent Oro-esophageal Tube Feeding	Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The observation group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding. Diaphragm Training will be given twice a day and 30min per time.
Routine rehabilitation+Diaphragm Training	Diaphragm Training	Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The observation group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding. Diaphragm Training will be given twice a day and 30min per time.
Routine rehabilitation+Diaphragm Training	Routine rehabilitation	Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The observation group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding. Diaphragm Training will be given twice a day and 30min per time.
Routine rehabilitation	Intermittent Oro-esophageal Tube Feeding	Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The observation group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding.

Primary Outcome Measures

Name	Time	Method
Penetration-Aspiration Scale	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 Outcome Measures

Name	Time	Method
Functional Oral Intake Scale	Day 1 and day 15	The scale reflects the patient's oral intake. Studies have shown that this scale can also serve as an independent measure of intake for post-stroke dysphagia patients. The scale is divided into 7 levels, with the level positively correlated with swallowing function. Level 7 indicates normal swallowing function.
Dysphagia Handicap Index	Day 1 and day 15	Dysphagia Handicap Index is a self-reported questionnaire used to assess the impact of dysphagia on an individual's quality of life. It typically consists of multiple questions related to the physical, functional, and emotional aspects of swallowing difficulties. The total score range varies between 0 and 100. A higher score indicates a greater perceived impact of dysphagia on the individual's quality of life.