The Impact of Chewing Food on Stroke Patients With Dysphagia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Modified Barium Swallow Impairment Profile
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Chewing Food Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with real food for 15 days.
Intervention: routine rehabilitation therapy (Behavioral)
Chewing Food Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with real food for 15 days.
Intervention: Oral tube feeding (Behavioral)
Control Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with lotus root powder for 15 days.
Intervention: routine rehabilitation therapy (Behavioral)
Chewing Food Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with real food for 15 days.
Intervention: Chewing Real Food (Behavioral)
Control Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with lotus root powder for 15 days.
Intervention: Oral tube feeding (Behavioral)
Control Group
This group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with lotus root powder for 15 days.
Intervention: Chewing Lotus Root Powder Food (Behavioral)
Outcomes
Primary Outcomes
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
- Rehabilitation adherence(Day 1 and day 15)
- 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)
Investigators
Zeng Xi
The Research Director
Buraidah Central Hospital