Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT06286020
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D014854', 'term': 'Lateral Medullary Syndrome'}], 'ancestors': [{'id': 'D020526', 'term': 'Brain Stem Infarctions'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, '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': 'RECRUITING', 'startDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-02', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'standardized swallowing assessment', 'timeFrame': 'day 1 and day 14', 'description': 'The standardized swallowing assessment was used to assess the improvement of overall swallowing function, it has a maximum score of 46 and a minimum score of 18, with lower scores indicating better swallowing function.'}], 'secondaryOutcomes': [{'measure': 'Murray secretion scale', 'timeFrame': 'day 1 and day 14', 'description': 'The severity of Murray secretion scale was measured using a grade of 0-3, patients without obvious saliva accumulation are scored as Murray secretion scale grade 0, whereas patients who had secretions in the laryngeal vestibule at the start of the exam were assigned grade 3.'}, {'measure': 'Rosenbek penetration-aspiration scale', 'timeFrame': 'day 1 and day 14', 'description': 'The highest Rosenbek penetration-aspiration scale score is 8 and the lowest is 1 (1 = no entry of material into the airway; 2 - 5 = penetration of material past the mouse into the supraglottic space and traveling as far as the true vocal folds; 6 - 8 = tracheal aspiration of material below the true vocal folds).'}, {'measure': 'swallowing-quality of life', 'timeFrame': 'day 1 and day 14', 'description': 'Swallowing-quality of life has a score range of 44 - 220, with lower scores indicating poorer swallowing function and poorer quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wallenberg Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:\n\nthe efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.\n\nParticipants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy.', 'detailedDescription': 'Virtual Reality technology has revolutionized various fields, and its application in rehabilitation medicine is particularly noteworthy. Virtual Reality provides immersive environments that simulate real-life situations, making it an invaluable tool in the rehabilitation process.\n\nThe goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:\n\nthe efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.\n\nParticipants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age ranged from 18-85 years and right-handed;\n* first onset, vital signs stable and conscious;\n* the dysphagia confirmed by videofluoroscopic swallowing study;\n* no cognitive impairment, the mini-mental state examination score: \\>17 for those with an illiterate education, \\>20 for those with an elementary education, and \\>24 for those with a secondary education and above;\n* cranial integrity without craniotomy and/or craniectomy;\n* patient and/or his/her relative agrees and signs written informed consent.\n\nExclusion Criteria:\n\n* combined ischemic foci at other sites;\n* presence of organic swallowing dysfunction or pre-existing dysphagia due to Parkinson's disease, dementia, and others;\n* severe cardiac, pulmonary, hepatic, and renal insufficiency and vital organ failure;\n* infected or broken skin on the head;\n* poorly controlled epilepsy;\n* poor patient compliance."}, 'identificationModule': {'nctId': 'NCT06286020', 'briefTitle': 'Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Zhengzhou University"}, 'officialTitle': 'A Randomized Controlled Study to Explore the Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome', 'orgStudyIdInfo': {'id': 'VR-Zhenqiu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The experimental group', 'description': 'conventional dysphagia treatment and Virtual Reality Therapy are provided', 'interventionNames': ['Device: Virtual Reality Therapy', 'Behavioral: Conventional dysphagia treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The control group', 'description': 'conventional dysphagia treatment is provided', 'interventionNames': ['Behavioral: Conventional dysphagia treatment']}], 'interventions': [{'name': 'Virtual Reality Therapy', 'type': 'DEVICE', 'description': "The therapist begins by assessing the patient's swallowing abilities and creating a personalized treatment plan. This involves determining the appropriate Virtual Reality Therapy scenarios, difficulty levels, and specific swallowing goals tailored to the patient's condition.", 'armGroupLabels': ['The experimental group']}, {'name': 'Conventional dysphagia treatment', 'type': 'BEHAVIORAL', 'description': 'Conventional dysphagia treatment included oropharyngeal muscle movement training, orofacial alternating hot and cold stimulation, Masako swallowing training, Mendelsohn maneuver, therapeutic ingestion training, intermittent oral-esophageal tube feeding, etc., 30 min each time, once a day for 14 consecutive days.', 'armGroupLabels': ['The control group', 'The experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xinzhu', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Haim Liu', 'role': 'CONTACT'}], 'facility': 'Xinzhu Rehabilitation Hospital', 'geoPoint': {'lat': 22.46205, 'lon': 120.47335}}], 'centralContacts': [{'name': 'Zhefeng Zeng, Master', 'role': 'CONTACT', 'email': 'zhengzhouzhj@qq.com', 'phone': '19501376864'}, {'name': 'Weiji Zhao, Doctor', 'role': 'CONTACT', 'email': 'zwjww2009@163.com', 'phone': '17839973473'}], 'overallOfficials': [{'name': 'Nieto Luis, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Site Coordinator of United Medical Group located in Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeng Changhao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Director', 'investigatorFullName': 'Zeng Changhao', 'investigatorAffiliation': "People's Hospital of Zhengzhou University"}}}}