The Impact of Chewing Food on Stroke Patients

NCT ID: NCT06637033

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2025-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chewing Food Group

This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with real food for 15 days.

Group Type: EXPERIMENTAL

Chewing Real Food

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Control Group

This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with lotus root powder for 15 days.

Group Type: ACTIVE_COMPARATOR

routine rehabilitation therapy

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

Chewing Real Food

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.

Intervention Type: BEHAVIORAL

routine rehabilitation therapy

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.

Intervention Type: BEHAVIORAL

Oral 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.

Intervention Type: BEHAVIORAL

Chewing Lotus Root Powder Food

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Babujinaya Cela

OTHER_GOV

Sponsor Role: lead

Responsible Party

Babujinaya Cela

The Research Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hongji Zeng, PhD

Role: PRINCIPAL_INVESTIGATOR

ZZU First Hospital

Locations

Renmin Hospital of SND

Suzhu, , China

ZZU No.1 Hospital

Zhenzhou, , China

Countries

China

Other Identifiers

Jujue-stroke

Identifier Type: -

Identifier Source: org_study_id