Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT05875818
Status:
UNKNOWN
Last Update Posted:
2023-05-25
First Post:
2023-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function 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': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2023-03-18', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugal Myer assessment scale (FMAS)', 'timeFrame': '6 Months', 'description': 'Fugal Myer assessment scale (FMAS) to check the pain and funcationality in stroke'}, {'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': '6 Months', 'description': 'Modified Ashworth Scale (MAS) to check the pain and funcationality in stroke'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'To determine the effects of Tele-rehabilitation versus in-clinical rehabilitation for upper limb motor function and spasticity in chronic ischemic stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients from both genders.\n\n * Patients with chronic ischemic stroke i.e. 6 months or more.\n * Patients with 45 years old and above.\n * On modified Ashworth scale, patient with limb spasticity equal to 2 or less than 2.\n * On Mini Mental State Examination (MMSE), patients with good cognitive function minimum 24 or more.\n\nExclusion Criteria:\n\n* • Patients with any recurrent stroke history.\n\n * Cognitive deficit patients (on Folstein Mini Mental state Examination score of less than 24)\n * Patient having other neurological diseases.'}, 'identificationModule': {'nctId': 'NCT05875818', 'briefTitle': 'Comparison of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Comparison of Effects of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients', 'orgStudyIdInfo': {'id': 'DPT/Batch-Fall18/542'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tele-rehabilitation', 'interventionNames': ['Diagnostic Test: Tele-rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'In-clinic Rehabilitation', 'interventionNames': ['Diagnostic Test: In-clinic Rehabilitation']}], 'interventions': [{'name': 'In-clinic Rehabilitation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Effects of In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients', 'armGroupLabels': ['In-clinic Rehabilitation']}, {'name': 'Tele-rehabilitation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Effects of Tele-rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients', 'armGroupLabels': ['Tele-rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'facility': 'Chaudary Muhammad Akram Teaching Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Hina Riaz, DPT', 'role': 'CONTACT', 'email': 'dptm-f18-168@superior.edu.pk', 'phone': '+923364795589'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}