StrokeNCT06637033
The Impact of Chewing Food on Stroke Patients
A study testing Chewing Real Food, routine rehabilitation therapy and Oral tube feeding in people with Stroke, run by Zeng Xi at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Chewing Real Food, routine rehabilitation therapy and Oral tube feeding
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 15 Nov 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Impact of Chewing Food on Stroke Patients With Dysphagia: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Chewing Real Food, routine rehabilitation therapy, Oral tube feeding, Chewing Lotus Root Powder Food
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing Real FoodBehavioural
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 therapyBehavioural
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 feedingBehavioural
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 FoodBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: routine rehabilitation therapy; Behavioral: Oral tube feeding; Behavioral: Chewing Lotus Root Powder Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and day 15
Secondary outcomes (5)
Dysphagia Handicap Index
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
Measured: Day 1 and day 15
Penetration-Aspiration Scale
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.
Measured: Day 1 and day 15
7-item Generalized Anxiety Disorder
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.
Measured: Day 1 and day 15
Stroke Self-Efficacy Questionnaire
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.
Measured: Day 1 and day 15
Rehabilitation adherence
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?"
Measured: Day 1 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Nov 2024
- Primary completion16 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeng Xi
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zeng Xi, Buraidah Central Hospital
- Investigators
- Hongji Zeng, PhD, Principal investigator, ZZU First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637033
- Sponsor's protocol ID
- Jujue-stroke
- Status last verified
- May 2026
- First submitted
- 30 Sep 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chewing Food on Stroke Patients With Dysphagia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06637033
- Acronym / sponsor ID
- Jujue-stroke
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zeng XiOther government
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing Food Group | Experimental | Behavioral: Chewing Real Food, Behavioral: routine rehabilitation therapy, Behavioral: Oral tube feedingThis group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with real food for 15 days. |
| Control Group | Active comparator | Behavioral: routine rehabilitation therapy, Behavioral: Oral tube feeding, Behavioral: Chewing Lotus Root Powder FoodThis group will be given routine rehabilitation training, oral tube feeding and Chewing Food training with lotus root powder for 15 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>18 years.
- Meeting the diagnostic criteria for ischemic stroke .
- Dysphagia confirmed by Videofluoroscopic Swallowing Study.
- Clear consciousness.
- No history of prior stroke.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing Real FoodDaily 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. | Behavioural | Chewing Food Group |
| routine rehabilitation therapyIncluding： 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. | Behavioural | Chewing Food Group, Control Group |
| Oral tube feedingBefore 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. | Behavioural | Chewing Food Group, Control Group |
| Chewing Lotus Root Powder FoodLotus 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. | Behavioural | Control Group |
Primary outcome
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.
5 secondary outcomes
Dysphagia Handicap Index
Time frame: Day 1 and day 15
Penetration-Aspiration Scale
Time frame: Day 1 and day 15
7-item Generalized Anxiety Disorder
Time frame: Day 1 and day 15
Stroke Self-Efficacy Questionnaire
Time frame: Day 1 and day 15
Rehabilitation adherence
Time frame: Day 1 and day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongji Zeng, PhD principal investigator
ZZU First Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing Real Food, routine rehabilitation therapy and Oral tube feeding in people with Stroke, run by Zeng Xi at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Barium Swallow Impairment Profile (time frame: Day 1 and day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.