Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT06582394
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-03
First Post:
2024-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual BASRD Reality Training Versus Conservative Treatment In Chronic Hemipretic Stroke Survivors
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Barthel index', 'timeFrame': '12 Months', 'description': "The Barthel Index is a scale used to measure a person's ability to perform basic activities of daily living (ADL) independently. It assesses 10 areas of functioning, with a focus on mobility and self-care. Scores range from 0 to 100, with higher scores indicating greater independence. Stroke-Specific Quality of Life Scale (SS-QOL) It assesses the impact of stroke on the quality of life across various domains, including physical, emotional, social, and cognitive aspects. It uses 12 domains with items scored on a 5-point Likert scale"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': "In hemiparetic stroke patient's VR is very useful. Due to hemiparesis one side muscle weakness occurs because of disruption in brain, spinal cord and nervous system technologies improvs motor activities of patients, by improvement in motor activities patients perform activities in better way.", 'detailedDescription': "The study's main aim is to check virtual reality's effect on conservative treatment in hemiparetic stroke patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Both ischemia and hemorrhagic stroke.\n* Stroke Patients who were in Chronic phase diagnosed by Physician were included in the study.\n\nExclusion Criteria:\n\n* Patient with the history of previous stroke attacks.\n* Brainstem stroke\n* Epilepsy\n* Severely impaired communication and cognition\n* Parkinson's disease and multiple sclerosis\n* Other musculoskeletal and psychological disorder"}, 'identificationModule': {'nctId': 'NCT06582394', 'briefTitle': 'Effect of Virtual BASRD Reality Training Versus Conservative Treatment In Chronic Hemipretic Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Effect of Virtual BASRD Reality Training Versus Conservative Treatment In Chronic Hemipretic Stroke Survivors', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall22/738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exp Group', 'interventionNames': ['Combination Product: Exp Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Exp Group', 'type': 'COMBINATION_PRODUCT', 'description': 'Balance and coordination were targeted through virtual stepping tasks, where participants practiced stepping in various directions to improve postural control and lower limb function. Additionally, they performed virtual balance exercises by standing on simulated platforms of varying stability. For gait and mobility, participants practiced walking in a virtual environment with real-time feedback to correct gait abnormalities. They also encountered virtual obstacles, which required them to adapt their walking patterns and improve mobility. In this study, both the intervention and control groups underwent a 6-week treatment plan consisting of 5 sessions per week, with each session lasting 45 minutes.', 'armGroupLabels': ['Exp Group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'For gait training, participants practiced walking on flat surfaces, sometimes with the assistance of parallel bars or walking aids, to improve their walking speed, step length, and rhythm. They also performed sit-to-stand exercises to strengthen the lower limbs and improve mobility for daily activities. Additionally, manual therapy techniques, such as joint mobilizations and stretching, were applied to reduce spasticity and increase range of motion in the affected limbs. Both treatment groups progressed based on individual capabilities, with therapists adjusting exercises accordingly throughout the study. In this study, both the intervention and control groups underwent a 6-week treatment plan consisting of 5 sessions per week, with each session lasting 45 minutes.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Depalpur', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}