Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT06256861
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Myofascial Release on Dysphagia in Patients With Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000089803', 'term': 'Myofascial Release Therapy'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-02', 'studyFirstSubmitDate': '2024-02-03', 'studyFirstSubmitQcDate': '2024-02-03', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Penetration-Aspiration Scale', 'timeFrame': 'day 1 and day 21', 'description': 'Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. The scores ranged 1 point to 8 points. As the level increased, the severity of dysphagia also increased.'}], 'secondaryOutcomes': [{'measure': 'Swallowing Quality of Life questionnaire', 'timeFrame': 'day 1 and day 21', '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.'}, {'measure': 'Patient health questionnaire-9', 'timeFrame': 'day 1 and day 21', 'description': 'The depression of the patients was evaluated with the patient health questionnaire-9. The scores ranged 0-27. As the scores increased, the severity of depression also increased.'}, {'measure': 'Functional Oral Intake Scale', 'timeFrame': 'day 1 and day 21', 'description': "During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:\n\n• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.', 'detailedDescription': 'Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Traumatic Brain injured Survivors. The main question it aims to answer is:\n\n• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury.\n* presence of no contraindication for enteral nutrition;\n* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;\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 Myofascial Release;\n* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.'}, 'identificationModule': {'nctId': 'NCT06256861', 'briefTitle': 'Effect of Myofascial Release on Dysphagia in Patients With Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': "People's Hospital of Zhengzhou University"}, 'officialTitle': 'A Randomized Controlled Study to Explore Effect of Myofascial Release on Dysphagia in Patients With Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'Jinmo-TBI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The experimental group', 'description': 'Study lasts 21 days for each patient. All patients are given rehabilitation treatment.The experimental group was given the Myofascial Release Therapy, five days a week, once a day, for 30-60 minutes each time.', 'interventionNames': ['Behavioral: Rehabilitation treatment', 'Behavioral: Myofascial Release Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The control group', 'description': 'Study lasts 21 days for each patient. All patients are given rehabilitation treatment, five days a week, once a day, for 30-60 minutes each time.', 'interventionNames': ['Behavioral: Rehabilitation treatment']}], 'interventions': [{'name': 'Rehabilitation treatment', 'type': 'BEHAVIORAL', 'description': 'This group is given rehabilitation treatment. 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.', 'armGroupLabels': ['The control group', 'The experimental group']}, {'name': 'Myofascial Release Therapy', 'type': 'BEHAVIORAL', 'description': 'Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. Myofascial release therapy is commonly used to treat muscle spasms, chronic pain, skeletal and joint issues, among others.', 'armGroupLabels': ['The experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Xi Maheen, Master', 'role': 'CONTACT'}], 'facility': 'Saint Martin Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Zhefeng Wang, Master', 'role': 'CONTACT', 'email': 'zhengzhouzhj@qq.com', 'phone': '19501376864'}, {'name': 'Weiji Zhao, Master', 'role': 'CONTACT', 'email': 'zwjww2009@163.com', 'phone': '17839973473'}], 'overallOfficials': [{'name': 'Nieto Luis, Master', 'role': 'STUDY_CHAIR', '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': 'PI', 'investigatorFullName': 'Zeng Changhao', 'investigatorAffiliation': "People's Hospital of Zhengzhou University"}}}}