Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT06674356
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2024-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Chin Tuck Against Resistance Exercise on Acute Stroke Patients With Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], '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'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2024-11-03', 'studyFirstSubmitQcDate': '2024-11-03', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'swallowing function', 'timeFrame': 'before intervention and up to 6 weeks', 'description': 'Use the Functional Oral Intake Scale(FOIS) 、calculating the residual volume of 60 ml of water, swallowing speed, and whether a nasogastric tube is in place to assess swallowing function. FOIS items range from 1 to 7，the higer the better swallowing function。The less residual water and fast swallowing speed(ml/sec), the better the swallowing function. The absence of a nasogastric tube also indicates improvement in swallowing.'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'before intervention and up to 6 and 10 weeks', 'description': 'Use the Patient Health Questionnaire(PHQ-9) to assess depression，the score ranges from 0 to 27 points: 0-4 indicates no depressive symptoms, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20-27 indicates severe depression.'}, {'measure': 'Swallowing-Related Quality of Life', 'timeFrame': 'before intervention and up to 6 and 10 weeks', 'description': 'use the Taiwanese version of the Swallowing Quality of Life Questionnaire to evaluate quality of Life. The questionnaire consists of 44 questions, scored on a 5-point Likert scale. Each question has a maximum score of 5 and a minimum score of 1. Higher scores on the questionnaire indicate a better quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Stroke', 'Dysphagia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of chin tuck against resistance exercise on swallowing function, depression, and quality of life in acute stroke patients with dysphagia.', 'detailedDescription': 'The study is an experimental research design, with participants randomly assigned to either the experimental group or the control group. The experimental group will undergo chin tuck against resistance exercises, while the control group will receive traditional swallowing rehabilitation training. The subjects of this study are patients from the neurology and rehabilitation wards of a medical center in northern Taiwan. The research tools include a personal basic information questionnaire, the standardized swallowing assessment, the Functional Oral Intake Scale, the Patient Health Questionnaire-9, and the Taiwan version of the Swallowing Quality of Life Questionnaire. Data collection for both groups will be conducted using a pre-test and post-test method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients diagnosed with hemorrhagic or ischemic stroke, including those with initial diagnoses or recurrent strokes.\n2. Patients who did not pass the swallowing screening based on the standard swallowing scale.\n3. Adults aged 18 years and older.\n4. Vital signs are stable: systolic blood pressure (hemorrhagic \\< 160 mmHg, ischemic \\< 220 mmHg), heart rate 40-130 beats per minute, and oxygen saturation \\> 92%.\n5. The patient's consciousness is clear, able to express themselves, can communicate in Mandarin or Taiwanese, and can follow commands to perform actions.\n6. The patient can be in a seated position.\n\nExclusion Criteria:\n\n1. Patients who have had a stroke for more than one month (inclusive).\n2. Patients with a history of depression or related mental health disorders.\n3. Patients with a history of neck pain, injury, or disease.\n4. Patients who have previously undergone tracheostomy or have a tracheostomy tube in place."}, 'identificationModule': {'nctId': 'NCT06674356', 'briefTitle': 'The Effects of Chin Tuck Against Resistance Exercise on Acute Stroke Patients With Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Effects of Chin Tuck Against Resistance Exercise on Swallowing Function, Depression, and Quality of Life in Acute Stroke Patients With Dysphagia', 'orgStudyIdInfo': {'id': '202408146RINB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Experimental Group:Participants in this group will receive traditional swallowing rehabilitation combined with chin tuck against resistance (CTAR) training to enhance suprahyoid muscle strength and improve swallowing function.', 'interventionNames': ['Behavioral: chin tuck against resistance exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Control Group:Participants in this group will receive only traditional swallowing rehabilitation without any additional CTAR training.', 'interventionNames': ['Behavioral: chin tuck against resistance exercise']}], 'interventions': [{'name': 'chin tuck against resistance exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Traditional swallowing rehabilitation'], 'description': 'Both groups of patients will receive traditional swallowing rehabilitation therapy; however, the experimental group will additionally perform CTAR exercises. The procedure is as follows:Ask the patient to sit, then, press the chin firmly against the inflatable rubber ball, for isometric exercise, the chin is pressed down against the resistance of the ball and held for 60 seconds as one round, with a total of three rounds. And for isotonic exercise, the chin presses down against the resistance of the ball and holds for one second per repetition, with a total of 30 repetitions. Performing both isometric and isotonic exercises constitutes one set of exercises.\n\nFor isometric exercise, the chin is pressed down against the resistance of the ball and held for 60 seconds as one round, with a total of three rounds. For isotonic exercise, the chin presses down against the resistance of the ball and holds for one second per repetition, with a total of 30 repetitions.', 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Fang-Ju Lin', 'role': 'CONTACT'}], 'facility': 'Department of Nursing, National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Fang-Ju Lin', 'role': 'CONTACT', 'email': 'linfunzoe@ntuh.gov.tw', 'phone': '+886-23123456', 'phoneExt': '262788'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}