Cerebrovascular AccidentNCT06301646
Oral Enteral Nutrition Tube Feeding on Stroke Survivors
A study testing Intermittent Oro-esophageal Tube Feeding, Nasogastric Tube Feeding and comprehensive rehabilitation therapy in people with Cerebrovascular Accident, run by Ahmadu Bello University Teaching Hospital.
Trial summary
The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are: Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Intermittent Oro-esophageal Tube Feeding, Nasogastric Tube Feeding and comprehensive rehabilitation therapy
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jun 2024
- 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 of stroke;
- any degree of dysphagia at admission;
- steady vital signs, without severe cognitive impairment or sensory aphasia.
- transferred out within three weeks of hospitalization in the neurology department.
Who cannot join
- complicated with other neurological diseases;
- damaged mucosa or incomplete structure in nasopharynx;
- tracheostomy tube plugged;
- unfeasible to the support of parenteral nutrition;
- simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial To Explore the Effect of Oral vs. Nasal Enteral Nutrition Tube Feeding on Stroke Survivors in Social Interaction and Psychological Status
The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:
Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.
Read the detailed description
Stroke is happening increasingly more. The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:
Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.
- Conditions
- Cerebrovascular Accident
- Being tested
- Intermittent Oro-esophageal Tube Feeding, Nasogastric Tube Feeding, comprehensive rehabilitation therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Oro-esophageal Tube FeedingDevice
The specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed. Before each feeding, the infant's oral and nasal secretions were to be cleared. An intermittent oro-esophageal tube was appropriately lubricated with water on the head part. The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus. The depth of insertion depended on the patient's age and height. After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux.
Nasogastric Tube FeedingDevice
Nasogastric Tube Feeding were used for feeding to provide nutritional support. Each feeding was administered by a nurse using the infant's mother's breast milk through the tube. The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day. The duration of each feeding procedure ranged from 10 to 20 minutes. The total daily intake ranged from 200 to 1000 ml. Each tube was kept indwelling for 5 to 7 days. When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support.
comprehensive rehabilitation therapyBehavioural
Both groups were given comprehensive rehabilitation therapy. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.
| Study group | Role | What they receive |
|---|---|---|
| comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding | Experimental | Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The experimental group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding. Receives: Device: Intermittent Oro-esophageal Tube Feeding; Behavioral: comprehensive rehabilitation therapy |
| comprehensive rehabilitation therapy+Nasogastric Tube Feeding | Active comparator | Study lasts 15 days for each patient. The patients were given comprehensive rehabilitation. The control group was provided the support of enteral nutrition by Nasogastric Tube Feeding. Receives: Device: Nasogastric Tube Feeding; Behavioral: comprehensive rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Functioning Scale
The Social Functioning Scale includes multiple subscales, and the score range is generally 0-100. Higher scores indicate better social functioning, while lower scores indicate limited social functioning or problems.
Measured: day 1 and day 15
Secondary outcomes (3)
Social Support Questionnaire
Social Support Questionnaire's score range is generally 0-100. Generally, higher scores are better and indicate more social support.
Measured: day 1 and day 15
Anxiety
The anxiety was assessed using the Generalized Anxiety Disorder-7, including items related to fear, worry, attention, etc. The total score ranged from 0 to 21, which was positively correlated with potential anxiety.
Measured: day 1 and day 15
Depression
The depression was assessed using the Patient Health Questionnaire-9, with aspects including mood swings, optimism, sleep quality, appetite, etc. The total score ranged from 0 to 27, which was positively correlated with potential depression.
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 posted8 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmadu Bello University Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad, Ahmadu Bello University Teaching Hospital
- Investigators
- Nieto Luis, Master, Study director, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301646
- Sponsor's protocol ID
- IOE-psy
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial To Explore the Effect of Oral vs. Nasal Enteral Nutrition Tube Feeding on Stroke Survivors in Social Interaction and Psychological Status
- ClinicalTrials.gov ID
- NCT06301646
- Acronym / sponsor ID
- IOE-psy
- Conditions
- Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ahmadu Bello University Teaching HospitalUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 8 Mar 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 Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:
Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.
Detailed description
Stroke is happening increasingly more. The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:
Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding | Experimental | Device: Intermittent Oro-esophageal Tube Feeding, Behavioral: comprehensive rehabilitation therapyStudy lasts 15 days for each patient. The patients were given comprehensive rehabilitation therapy. The experimental group was provided the support of enteral nutrition by Intermittent Oro-esophageal Tube Feeding. |
| comprehensive rehabilitation therapy+Nasogastric Tube Feeding | Active comparator | Device: Nasogastric Tube Feeding, Behavioral: comprehensive rehabilitation therapyStudy lasts 15 days for each patient. The patients were given comprehensive rehabilitation. The control group was provided the support of enteral nutrition by Nasogastric Tube Feeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years;
- meeting the diagnostic criteria of stroke;
- any degree of dysphagia at admission;
- steady vital signs, without severe cognitive impairment or sensory aphasia.
- transferred out within three weeks of hospitalization in the neurology department.
Key exclusion criteria (5 listed)
- complicated with other neurological diseases;
- damaged mucosa or incomplete structure in nasopharynx;
- tracheostomy tube plugged;
- unfeasible to the support of parenteral nutrition;
- simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
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 |
|---|---|---|
| Intermittent Oro-esophageal Tube FeedingThe specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed. Before each feeding, the infant's oral and nasal secretions were to be cleared. An intermittent oro-esophageal tube was appropriately lubricated with water on the head part. The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus. The depth of insertion depended on the patient's age and height. After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux. | Device | comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding |
| Nasogastric Tube FeedingNasogastric Tube Feeding were used for feeding to provide nutritional support. Each feeding was administered by a nurse using the infant's mother's breast milk through the tube. The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day. The duration of each feeding procedure ranged from 10 to 20 minutes. The total daily intake ranged from 200 to 1000 ml. Each tube was kept indwelling for 5 to 7 days. When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support. | Device | comprehensive rehabilitation therapy+Nasogastric Tube Feeding |
| comprehensive rehabilitation therapyBoth groups were given comprehensive rehabilitation therapy. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time. | Behavioural | comprehensive rehabilitation therapy+Intermittent Oro-esophageal Tube Feeding, comprehensive rehabilitation therapy+Nasogastric Tube Feeding |
Primary outcome
Social Functioning Scale
Time frame: day 1 and day 15
The Social Functioning Scale includes multiple subscales, and the score range is generally 0-100. Higher scores indicate better social functioning, while lower scores indicate limited social functioning or problems.
3 secondary outcomes
Social Support Questionnaire
Time frame: day 1 and day 15
Anxiety
Time frame: day 1 and day 15
Depression
Time frame: day 1 and day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Nieto Luis, Master study director
Site Coordinator of United Medical Group
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Oro-esophageal Tube Feeding, Nasogastric Tube Feeding and comprehensive rehabilitation therapy in people with Cerebrovascular Accident, run by Ahmadu Bello University Teaching Hospital.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lavie Ce, Master (15333828388, zenghongjixx@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Functioning Scale (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 8 Mar 2024.