The Impact of Chewing Food on Stroke Patients

NCT06637033 | Completed DMC

• 1 other identifier: Jujue-stroke
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Modified Barium Swallow Impairment Profile

  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.

  Day 1 and day 15

Secondary Outcomes (5)

• Dysphagia Handicap Index

  Day 1 and day 15

• Penetration-Aspiration Scale

  Day 1 and day 15

• 7-item Generalized Anxiety Disorder

  Day 1 and day 15

• Stroke Self-Efficacy Questionnaire

  Day 1 and day 15

• Rehabilitation adherence

  Day 1 and day 15

Study Arms (2)

Chewing Food Group

EXPERIMENTAL

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

Behavioral: Chewing Real Food; Behavioral: routine rehabilitation therapy; Behavioral: Oral tube feeding

Control Group

ACTIVE COMPARATOR

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

Behavioral: routine rehabilitation therapy; Behavioral: Oral tube feeding; Behavioral: Chewing Lotus Root Powder Food

Interventions

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.

Chewing Food Group

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.

Chewing Food Group; Control Group

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 Food Group; Control Group

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.

Control Group

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 for ischemic stroke .
• Dysphagia confirmed by Videofluoroscopic Swallowing Study.
• Clear consciousness.
• No history of prior stroke.
• Stable vital signs.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Babujinaya Cela: lead

Study Sites (2)

Renmin Hospital of SND

Suzhu, China

Location

ZZU No.1 Hospital

Zhenzhou, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Hongji Zeng, PhD

  ZZU First Hospital

  PRINCIPAL INVESTIGATOR

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: The Research Director

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 15, 2024
• Study Start: November 15, 2024
• Primary Completion: October 16, 2025
• Study Completion: October 31, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (2)