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

NCT06393218 | Not Yet Recruiting

• 1 other identifier: GEJI-Zhenqiu
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bulbar Palsy

Outcome Measures

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.

  Day 1 and day 15

Secondary Outcomes (2)

• Functional Oral Intake Scale

  Day 1 and day 15

• Dysphagia Handicap Index

  Day 1 and day 15

Study Arms (2)

Routine rehabilitation+Diaphragm Training

EXPERIMENTAL

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

Routine rehabilitation

ACTIVE COMPARATOR

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

Intermittent Oro-esophageal Tube Feeding DEVICE

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.

Routine rehabilitation; Routine rehabilitation+Diaphragm Training

Diaphragm Training BEHAVIORAL

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.

Routine rehabilitation+Diaphragm Training

Routine rehabilitation BEHAVIORAL

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.

Routine rehabilitation; Routine rehabilitation+Diaphragm Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copka Sonpashan: lead

MeSH Terms

Conditions

Bulbar Palsy, Progressive

Condition Hierarchy (Ancestors)

Motor Neuron Disease; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04