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

Lead sponsor

Copka Sonpashan is the lead sponsor of 40 studies on the registry; 38 are open to participants now.

Study arms

• Experimental
  Routine rehabilitation+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.

  Device: Intermittent Oro-esophageal Tube Feeding · Behavioral: Diaphragm Training · Behavioral: Routine rehabilitation

• Active comparator
  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.

  Device: Intermittent Oro-esophageal Tube Feeding · Behavioral: Routine rehabilitation

Interventions

• DeviceIntermittent Oro-esophageal Tube Feeding

  Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.

• BehavioralDiaphragm Training

  Diaphragm training includes both active and passive methods. Passive training involves placing weights on the participant's abdomen to provide resistance during breathing. Active training involves instructing participants to practice diaphragmatic breathing techniques.

• BehavioralRoutine rehabilitation

  Including： 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.

Primary outcomes

1. Penetration-Aspiration Scale

   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.

   Time frame: Day 1 and day 15

Secondary outcomes

1. Functional Oral Intake Scale

   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.

   Time frame: Day 1 and day 15

2. Dysphagia Handicap Index

   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.

   Time frame: Day 1 and day 15