Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT03574467
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2018-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional Outcomes of The Bobath Approach on Patients With Brain Tumors: Comparison With Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2018-06-11', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Stroke Rehabilitation Assessment of Movement Measure (STREAM)', 'timeFrame': 'Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.', 'description': 'The Stroke Rehabilitation Assessment of Movement Measure (STREAM) is a scale with scores ranging from 0 to 70, which is used to provide an understanding of the levels of movement and quality of hemiplegic patients.'}], 'secondaryOutcomes': [{'measure': 'The Functional Independent Measurement (FIM)', 'timeFrame': 'Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.', 'description': 'The Functional Independent Measurement (FIM) is 18-item scale and is scored from 18 (total assistance in all areas) to 126 (complete independence). FIM consists of 13 motor (or physical) and 5 social-cognitive items, assessing self care, sphincter control, transfer, locomotion, communication, social interaction, and cognition. The results from the first 13 items (FIM motor) are summed to develop a motor score with a range of 13 to 91, and these items were used in this study.'}, {'measure': 'Mini-Mental State Examination (MMSE)', 'timeFrame': 'Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.', 'description': "Mini-Mental State Examination (MMSE) is a scale with scores ranging from 0 to 30, which allows the cognitive levels to be determined by examining the patient's orientation, recording memory, attention and calculation, recall, and language parameters. The score of 0 indicates that the patient has no cognitive functions, and the score of 30 indicates that the patient has a high level of cognitive functions."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brain neoplasms', 'stroke', 'rehabilitation'], 'conditions': ['Brain Neoplasms', 'Stroke, Acute']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the functional recovery results of the Bobath (NDT) approach in patients with primary brain tumors and compare the results with those of stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Department of Neurology between June 2016 and April 2017, were analyzed for the study. The study inclusion criteria were determined for all patients to be over 18 years of age, in the acute phase, Glasgow Coma Scale score 14 and above, Modifiye Rankin Score being more than 2 and medical stability. Furthermore, the criteria for inclusion in the study were unilateral stroke and having a stroke for the first time for stroke patients, and supratentorial location for patients with brain tumors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute phase patients with brain tumor and stroke in after surgery\n\nExclusion Criteria:\n\n* Modified rankin scale \\<2\n* High grade tumor\n* Infratentorial tumor\n* GCS\\<14\n* Rehabilitation session time\\<3\n* Second or more tumor surgery\n* Second or more stroke\n* Bilateral stroke'}, 'identificationModule': {'nctId': 'NCT03574467', 'briefTitle': 'Functional Outcomes of The Bobath Approach on Patients With Brain Tumors: Comparison With Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Functional Outcomes of The Bobath Neurodevelopmental Treatment Approach Applied to Patients With Brain Tumors: Comparison With Stroke Patients', 'orgStudyIdInfo': {'id': 'GO 18/25-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bobath Approach Applied to Patient with Brain Tumors', 'interventionNames': ['Behavioral: Bobath Neurodevelopmental Treatment Approach']}, {'label': 'Bobath Approach Applied to Patient with Stroke', 'interventionNames': ['Behavioral: Bobath Neurodevelopmental Treatment Approach']}], 'interventions': [{'name': 'Bobath Neurodevelopmental Treatment Approach', 'type': 'BEHAVIORAL', 'description': 'The Bobath Neurodevelopmental Treatment (NDT) rehabilitation approach is effective in increasing the functional capacity and acquiring independence in patients with stroke and brain tumor.', 'armGroupLabels': ['Bobath Approach Applied to Patient with Brain Tumors', 'Bobath Approach Applied to Patient with Stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'Ankara', 'state': 'Altındağ', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Ceyhun Turkmen', 'investigatorAffiliation': 'Hacettepe University'}}}}