Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 8:14 PM
Study NCT ID:
NCT06899451
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2025-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-14', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-21', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': '5 months', 'description': 'is a five-point scaling score, a range of Zero - 4. "Zero" was given at the least level of function, while grade "4" will be given at the highest level of function. The scores are classified as follows: 41-56 = low fall risk, 21-40 = medium fall risk, and 0 -20 = high fall risk'}, {'measure': 'The 16-item Fall Efficacy Scale-International', 'timeFrame': '5 months', 'description': 'utilized to evaluate fear of falls.Varying from one (not concerned) to four (very concerned). For data analysis, the overall score, which was the sum of the 16 answers and ranged from 16 to 64 points, was utilized. A greater total score means the patients are more concerned about falling'}, {'measure': 'Timed Up and Go Test (TUG)', 'timeFrame': '5 months', 'description': 'starts with the patient getting up from the chair, walk 3 meters once a signal is given, walk 3 meters back to the chair, and then sit down calculating time taken by the patient'}], 'secondaryOutcomes': [{'measure': 'fear of falling', 'timeFrame': '5 months', 'description': 'Biodex Balance Systems'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fear of falling, balance, stroke'], 'conditions': ['Stroke, Ischemic', 'Stroke Hemorrhagic', 'Balance']}, 'descriptionModule': {'briefSummary': 'Several studies have reported that the physical functions associated with falls, including motor performance, postural balance, flexibility, and muscle strength, are also associated with FoF. Patients with stroke have trouble performing ADLs, including washing their face, eating, bathing, dressing, toileting, and walking, which also affect FoF. Anxiety and depression are common affective disorders in patients with stroke and significantly increase FoF .', 'detailedDescription': "People who are afraid of falling because they can't keep their balance can utilize This makes them less susceptible to fall and high tendency to prevent it."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nan ischemic stroke and having had the disease for longer than three months have frequent falling, having sufficient cognition (as measured by a Montreal Cognitive Assessment score of over 26) and having upper and lower extremity spasticity ranging from (grade 1+: 2) on a modified Ashworth scale\n\nExclusion Criteria\n\n) Musculoskeletal issues, such as severe arthritis, total hip arthroplasty, knee surgery, lower extremity fractures within the previous six months, or contractures brought on by a fixed deformity and/or disparity in leg length, 2) Instable medical conditions (e.g., unstable angina, recent myocardial infarction, history of congestive heart failure, major heart valve problems, or unstable hypertension);'}, 'identificationModule': {'nctId': 'NCT06899451', 'acronym': 'stroke', 'briefTitle': 'Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke.', 'orgStudyIdInfo': {'id': 'PT.BU.EC.13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'basophobia in stroke patients', 'description': 'The study will be conducted on 80 stroke patients , will randomly assigned to one of two groups using a secure system of opaque closed envelopes as study group (GA) and control group (GB) : -\n\n\\-', 'interventionNames': ['Other: systematic desensitization and balance']}], 'interventions': [{'name': 'systematic desensitization and balance', 'type': 'OTHER', 'otherNames': ['goal directed paradigm and balance'], 'description': "1. Systematic desensitization: 2 techniques\n\n 1. Jacobson's technique (progressive muscle relaxation):\n 2. Guided imagery training is a relaxation technique\n2. Goal-directed paradigm (selected program)", 'armGroupLabels': ['basophobia in stroke patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairou', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Heba Gaber, phd', 'role': 'STUDY_CHAIR', 'affiliation': 'ALRyada university for science and technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'AlRyada University for Science & Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapy for Neuromuscular Disorders , Faculty of Physical Therapy', 'investigatorFullName': 'Heba Mohamed Gaber', 'investigatorAffiliation': 'Cairo University'}}}}