Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT06739902
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-18
First Post:
2024-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing the Effectiveness of Traditional Physiotherapy Combined With Virtual Reality for Post-Stroke Patients
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': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2024-12-13', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale (BBS)', 'timeFrame': '12 Months', 'description': 'Assesses balance and stability.- \\*Purpose\\*: Assesses balance in older adults and individuals with balance disorders.\n\n* \\*Items\\*: 14 tasks, such as sitting, standing, reaching, and turning.\n* \\*Scoring\\*: Each task is scored on a scale of 0-4 (0 = inability to perform the task, 4 = normal performance).\n* \\*Total Score\\*: The maximum score is 56. Higher scores indicate better balance. A score below 45 indicates a higher risk of falling.'}, {'measure': 'Trunk Impairment Scale (TIS)', 'timeFrame': '12 Months', 'description': 'Measures trunk control and stability. SF-12 Health Survey: Evaluates quality of life in physical and mental health domains.The \\*Trunk Impairment Scale (TIS)\\* is a clinical tool used to assess trunk performance in individuals, particularly those with neurological impairments like stroke. It measures three key aspects: \\*static sitting balance, \\*\\*dynamic sitting balance, and \\*\\*coordination of trunk movements. The scale consists of \\*\\*17 items\\*, with scores ranging from 0 to 23. Higher scores indicate better trunk control and stability. It helps clinicians evaluate and track improvements in trunk function over time, guiding rehabilitation interventions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of combining virtual reality (VR) therapy with traditional physiotherapy in post-stroke rehabilitation. Post-stroke patients often suffer from impairments in motor function, balance, and overall quality of life. While traditional physiotherapy is a widely accepted method for stroke recovery, incorporating VR technology may enhance treatment outcomes by providing an engaging, immersive environment that motivates patients to perform therapeutic movements.', 'detailedDescription': 'This study will compare the functional and quality-of-life improvements in patients undergoing traditional physiotherapy alone versus those receiving a combination of conventional physiotherapy and VR interventions. By assessing changes in motor function, trunk stability, balance, and quality of life, this research will provide valuable insights into whether VR can be an effective adjunctive tool in post-stroke rehabilitation programs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Stroke, either ischemic or hemorrhagic\n* Participants who can ambulate independently or with minimal assistance.\n* Participants who were willing \\& able to adhere to the study protocol.\n* Including participants who were attending follow-up appointments \\& completing outcome measures.\n* Participants who were able to understand \\& provide written informed consent\n\nExclusion Criteria:\n\n* Existence of additional neurological disorders (such as multiple sclerosis or Parkinson's disease) or serious medical conditions that could prevent participants from participating in the study.\n* Participants receiving rehabilitation or rigorous physical treatment in the previous three months were excluded.\n* Pregnant women or breastfeeding women.\n* Participants who refused to participate in the study or provide informed consent."}, 'identificationModule': {'nctId': 'NCT06739902', 'briefTitle': 'Comparing the Effectiveness of Traditional Physiotherapy Combined With Virtual Reality for Post-Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Comparing the Effectiveness of Traditional Physiotherapy Combined With Virtual Reality for Post-Stroke Patients', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall22/770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group I', 'interventionNames': ['Diagnostic Test: Traditional Physiotherapy Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional group II', 'interventionNames': ['Combination Product: VR + Traditional Physiotherapy Group']}], 'interventions': [{'name': 'Traditional Physiotherapy Group', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants receive standard physiotherapy exercises aimed at improving motor function, balance, and trunk stability. These exercises include stretching, balance training, and muscle-strengthening activities.', 'armGroupLabels': ['Interventional group I']}, {'name': 'VR + Traditional Physiotherapy Group', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants receive the same physiotherapy exercises as the traditional group, but with additional sessions involving virtual reality exercises. The VR component includes immersive activities that stimulate motor control, coordination, and cognitive engagement to support functional recovery.', 'armGroupLabels': ['Interventional group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Services Hospital, Shadman 1', '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'}}}}