Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
Study NCT ID:
NCT06782750
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2024-12-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFFECT of PHYSIOTHERAPY in STROKE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], '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'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corpus Callosum Volume', 'timeFrame': 'up to 2 weeks', 'description': 'The measurements of the patients were evaluated on sagittal T2-weighted images. The slice thickness is 1.1 mm. Starting from the slice where the borders of the corpus callosum were clearly seen on the sagittal images, the circumference of the corpus callosum was marked on all sagittal slices where the borders of the corpus callosum were seen in consecutive slices.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corpus Callosum', 'Hemiplegia', 'Physiotherapy', 'Stroke'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The study was aimed to determine the volumetric change in the corpus callosum after the rehabilitation program in patients with stroke. A total of 42 patients (22 males, 20 females), 21 right hemiplegic and 21 left hemiplegic patients with unilateral hemiplegia were enrolled in the rehabilitation program. Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks. The corpus callosum volumes were measured and evaluated on Magnetic Resonance Imaging (MRI) images before and after the treatment.', 'detailedDescription': 'Physical therapy after stroke contributes to the physical and social recovery of the paralyzed person. Corpus callosum is the commissural fibers consisting of white matter connecting the cortical areas between hemispheres. Its main function is to provide information exchange and coordination by establishing interhemispheric connections between areas in the right and left hemispheres. Inactivity and decreased physical activity may cause a decrease in the volume of the corpus callosum in patients with stroke. It was aimed to determine the volumetric change in the corpus callosum after the rehabilitation program in patients with stroke. A total of 42 patients (22 males, 20 females), 21 right hemiplegic and 21 left hemiplegic patients with unilateral hemiplegia were enrolled in the rehabilitation program. Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks. The corpus callosum volumes were measured and evaluated on Magnetic Resonance Imaging (MRI) images before and after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were diagnosed with stroke, had unilateral hemiplegia, practiced a rehabilitation program at the Physical Medicine and Rehabilitation Clinic of XXX University, and had no other neurological disease, were selected for the right and left groups.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with stroke\n* Patients had unilateral hemiplegia\n* Patients practiced a rehabilitation program at the Physical Medicine and Rehabilitation\n\nExclusion Criteria:\n\n* Patients had other neurological disease\n* Patients had mental disorders'}, 'identificationModule': {'nctId': 'NCT06782750', 'briefTitle': 'EFFECT of PHYSIOTHERAPY in STROKE', 'organization': {'class': 'OTHER', 'fullName': 'Firat University'}, 'officialTitle': 'The EFFECT of PHYSIOTHERAPY on CORPUS CALLOSUM VOLUME in STROKE PATIENTS', 'orgStudyIdInfo': {'id': '250963'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemiplegic patients', 'description': 'Patients had unilateral hemiplegia, practiced a rehabilitation program at the Physical Medicine and Rehabilitation Clinic of Firat University, and had no other neurological disease, were selected for the right and left groups.', 'interventionNames': ['Other: Physiotherapy']}], 'interventions': [{'name': 'Physiotherapy', 'type': 'OTHER', 'description': 'Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks.', 'armGroupLabels': ['Hemiplegic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23119', 'city': 'Elâzığ', 'state': 'University', 'country': 'Turkey (Türkiye)', 'facility': 'Firat University', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}], 'overallOfficials': [{'name': 'Songul Baglan Yentur', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Firat University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Firat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Physiotherapy and Rehabilitatrion', 'investigatorFullName': 'Songül Bağlan Yentür', 'investigatorAffiliation': 'Firat University'}}}}