Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT07018102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nurse-Led Bedside Trunk Control Care Program
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trunk function', 'timeFrame': 'Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.', 'description': "Trunk Impairment Scale is used to assess patients' trunk function."}], 'secondaryOutcomes': [{'measure': 'Postural control', 'timeFrame': 'Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.', 'description': "Postural Assessment Scale for Stroke is used to assess patients' postural."}, {'measure': 'Respiratory function', 'timeFrame': 'Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.', 'description': 'Respiratory function was assessed by the technical staff in the rehabilitation ward. examination room'}, {'measure': 'Body awareness', 'timeFrame': 'Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.', 'description': "Body Awareness Questionnaire is used to assess patients' body awareness."}, {'measure': 'stroke impact', 'timeFrame': 'Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.', 'description': "Stroke Impact Scale is used to assess patients' quality of life."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trunk impairment', 'diaphragmatic breathing', 'quality of life', 'respiration function'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study aimed to apply care for stroke survivors by establishing trustable professional activities competency indicators and a trunk control care module for rehabilitation ward nurses during our second year.', 'detailedDescription': "Thus, the purposes of this study were: (1) to evaluate the effect of a stepwise nurse-led bedside trunk control care module intervention on improving trunk control, respiratory function, and quality of life in patients with stroke and (2) to modify and confirm the milestones and trustable professional activities of competence in trunk impairment care for patients with stroke to provide evidence-based nursing education and cultivate new nurses' competence in trunk injury care in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (a) Patients hospitalized for stroke in rehabilitation or neurology wards, currently in stable condition; (b) Trunk Impairment Scale score below 21; (c) aged 20 or above; (d) patients willing to participate.\n\nExclusion Criteria:\n\n* Patients with Trunk Impairment Scale score above 21, as this indicates that they can perform daily activities independently'}, 'identificationModule': {'nctId': 'NCT07018102', 'briefTitle': 'Nurse-Led Bedside Trunk Control Care Program', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Nurse-Led Bedside Trunk Control Care Program for Patients With Stroke', 'orgStudyIdInfo': {'id': 'CS1-23077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trunk Control Care Program', 'description': 'A step-wise nurse-led bedside trunk control care module intervention', 'interventionNames': ['Other: Trunk Control Care Program']}, {'type': 'NO_INTERVENTION', 'label': 'standard care', 'description': 'The control group received routine care including health education on turning over, positioning, and wheelchair use.'}], 'interventions': [{'name': 'Trunk Control Care Program', 'type': 'OTHER', 'description': '1. The intervention group underwent a 4-week bedside trunk control care module intervention based on routine care in a rehabilitation ward.\n2. trunk control care module: combine the care strategies of "arm training, butterfly technique, shoulder control, diaphragmatic breathing" and "body awareness", practice twice a day, each time for 20-30 minutes, and can be adjusted according to the patient\'s condition.', 'armGroupLabels': ['Trunk Control Care Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40201', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Hsiang Chu Pai, PhD', 'role': 'CONTACT', 'email': 'pai55215@csmu.edu.tw', 'phone': '0920096697'}], 'overallOfficials': [{'name': 'Hsiang Chu Pai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Hsiang Chu Pai', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}