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NCT Number: NCT06637033

The Impact of Chewing Food on Stroke Patients

The goal of this clinical trial is to explore the effect of Chewing Food on quality of life and nutritional status in ischemic stroke patients. Patients will be randomly divided into an interventional group and a control group, all receiving routine rehabilitation treatment and enteral nutrition feeding. On this basis, the interventional group will receive Chewing Food training before each feeding for 10 min. Researchers will compare changes in quality of life, and nutritional status of two groups of patients before and after the study to see if Chewing Food can improve the quality of life and nutritional status in ischemic stroke patients.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renmin Hospital of SND, Suzhu, China

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About this study

The study will last 15 days for each participant. The goal of this clinical trial is to explore the effect of Chewing Food on quality of life and nutritional status in ischemic stroke patients. Patients will be randomly divided into an interventional group and a control group, all receiving routine rehabilitation treatment and enteral nutrition feeding. On this basis, the interventional group will receive Chewing Food training before each feeding for 10 min. Researchers will compare changes in quality of life, and nutritional status of two groups of patients before and after the study to see if Chewing Food can improve the quality of life and nutritional status in ischemic stroke patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>18 years.
  • Meeting the diagnostic criteria for ischemic stroke .
  • Dysphagia confirmed by Videofluoroscopic Swallowing Study.
  • Clear consciousness.
  • No history of prior stroke.
  • Stable vital signs.

Exclusion criteria

  • Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
  • Complicated with severe liver and kidney failure, tumors, or hematological disorders.
  • Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
  • Pregnant or nursing females.

Treatment and study plan

Chewing Real Food

Behavioral

Daily foods like candies and dumplings will be cut into small pieces. Patients will chew them before each rehabilitation training and then spit them out, with each training session lasting ten minutes.

routine rehabilitation therapy

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.

Oral tube feeding

Behavioral

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.

Chewing Lotus Root Powder Food

Behavioral

Lotus Root Powder Food will be cut into small pieces. Patients will chew them before each rehabilitation training and then spit them out, with each training session lasting ten minutes.

Primary outcomes

  1. Modified Barium Swallow Impairment Profile

    Time frame: Day 1 and day 15

    The Modified Barium Swallow Impairment Profile is used to assess the clinical severity of oropharyngeal dysphagia. It includes 16 items and incorporates a standard Modified Barium Swallow test and is based on the gold standard of swallowing function assessment, Videofluoroscopic Swallowing Studies. The total score could range from 0 to 51, with higher scores indicating more severe oropharyngeal dysphagia.

Secondary outcomes

  1. Dysphagia Handicap Index

    Time frame: Day 1 and day 15

    The Dysphagia Handicap Index is a 25-item scale to evaluate swallowing-related quality of life. The scale scores range between 0 to 100 and a higher score indicate better quality of life

  2. Penetration-Aspiration Scale

    Time frame: Day 1 and day 15

    The Penetration-Aspiration Scale is used to evaluate airway protection. The level could range between 0 and 8, with higher scores indicating poor swallowing safety.

  3. 7-item Generalized Anxiety Disorder

    Time frame: Day 1 and day 15

    The 7-item Generalized Anxiety Disorder is used to assess anxiety. The total score could range from 0 to 21, with higher scores indicating more severe anxiety.

  4. Stroke Self-Efficacy Questionnaire

    Time frame: Day 1 and day 15

    Stroke Self-Efficacy Questionnaire is used to assess self-efficacy in functional independence and self-management. The total score could range from 0 to 130. A Higher score indicated better self-efficacy.

  5. Rehabilitation adherence

    Time frame: Day 1 and day 15

    Rehabilitation adherence is assessed using a 0-10 visual analog scale. The question is "How would you rate your current acceptance and compliance with rehabilitation training, where 10 is the highest and 0 is the lowest?"

Sponsors and collaborators

Lead sponsor

Zeng Xi

Other Gov

Registry information

Official study title

The Impact of Chewing Food on Stroke Patients With Dysphagia: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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