Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06328920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance for Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2024-03-09', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rehabilitation Treatment Compliance Questionnaire', 'timeFrame': 'day 1 and day 15', 'description': "The Rehabilitation Treatment Compliance Questionnaire assesses patient compliance with rehabilitation treatment plans. It consists of 12 items that cover aspects such as the patient's understanding of the treatment plan, attitude towards treatment, compliance, and perception of rehabilitation outcomes.\n\nThe scoring range for The Rehabilitation Treatment Compliance Questionnaire is typically from 12 to 60 points. A higher score indicates better understanding of the treatment plan, more positive attitude towards treatment, higher compliance with the treatment plan, and better perception of rehabilitation outcomes."}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire-9', 'timeFrame': 'day 1 and day 15', 'description': 'The total score of the Patient Health Questionnaire-9 ranges from 0 to 27, with higher scores indicating more severe depression symptoms.'}, {'measure': 'Swallowing Quality of Life questionnaire', 'timeFrame': 'day 1 and day 15', 'description': 'Swallowing Quality of Life questionnaire was used to evaluate the quality of life, which consists of 44 items and divided into 11 main domains, including: overall satisfaction, understanding, diet, hydration, communication, respiratory issues, postoperative recovery, social impact, mental health, saliva control, and appearance. The maximum rough score was 220 points, which was converted into a standard percentage system in our study. As the scores increased, the quality of life was better.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.', 'detailedDescription': 'The study will last 15 days for each participant. The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years;\n* meeting the diagnostic criteria of stroke;\n* any degree of dysphagia at admission;\n* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.\n* transferred out within three weeks of hospitalization in the neurology department.\n\nExclusion Criteria:\n\n* complicated with other neurological diseases;\n* damaged mucosa or incomplete structure in nasopharynx;\n* tracheostomy tube plugged;\n* unfeasible to the support of parenteral nutrition;\n* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.'}, 'identificationModule': {'nctId': 'NCT06328920', 'briefTitle': 'Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance for Stroke', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Chao Phya Abhaibhubejhr Hospital'}, 'officialTitle': 'A Randomized Controlled Study to Explore the Effect of Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients', 'orgStudyIdInfo': {'id': 'IOE Yicongxing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent Oro-esophageal Tube Feeding', 'description': 'The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure. The feeding content was formulated by the nutritionists based on the condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups', 'interventionNames': ['Device: Intermittent Oro-esophageal Tube Feeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nasogastric Tube Feeding', 'description': "The control group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the patient's cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time.", 'interventionNames': ['Device: Nasogastric Tube Feeding']}], 'interventions': [{'name': 'Intermittent Oro-esophageal Tube Feeding', 'type': 'DEVICE', 'description': 'The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure: 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.', 'armGroupLabels': ['Intermittent Oro-esophageal Tube Feeding']}, {'name': 'Nasogastric Tube Feeding', 'type': 'DEVICE', 'description': "The control group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the patient's cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time.", 'armGroupLabels': ['Nasogastric Tube Feeding']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Qianyun Ce', 'role': 'CONTACT', 'email': 'zengxizdyfy@126.com', 'phone': '17839993611'}], 'overallOfficials': [{'name': 'Nieto Luis', 'role': 'STUDY_CHAIR', 'affiliation': 'Site Coordinator of United Medical Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copka Sonpashan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The Research Director', 'investigatorFullName': 'Copka Sonpashan', 'investigatorAffiliation': 'Chao Phya Abhaibhubejhr Hospital'}}}}