CClinicalTrials.gg
Not yet recruitingNCT06393218Updated May 1, 2024

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

An interventional study of Intermittent Oro-esophageal Tube Feeding and Diaphragm Training in Bulbar Palsy, sponsored by Copka Sonpashan. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-01.

Sponsored by Copka Sonpashan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bulbar Palsy

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

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.

05

What researchers measure

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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06393218
Lead sponsor
Copka Sonpashan
Responsible party
Copka Sonpashan (Research Director, Chao Phya Abhaibhubejhr Hospital) — Sponsor-investigator
First posted
May 1, 2024
Start date
Apr 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
May 1, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion