Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT05634993
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2022-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Disability Level and Trunk Control in Individuals With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2022-11-11', 'studyFirstSubmitQcDate': '2022-11-23', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expanded Disability Status Scale', 'timeFrame': 'baseline', 'description': 'It is used for the follow-up of neurological disability and disease stage in MS patients. A score of 0 on the scale indicates normal neurological status, while a score of 10 means death due to MS. The higher the score, the higher the disability level.'}, {'measure': 'Trunk Impairment Scale', 'timeFrame': 'baseline', 'description': 'This scale; It consists of 3 sub-headings: static sitting balance, dynamic sitting balance and coordination. The lowest score that can be obtained from the scale is 0, and the highest score is 23. The higher the score, the higher the trunk control.'}, {'measure': '"Sit-ups" test', 'timeFrame': 'baseline', 'description': 'This test is used to evaluate the strength of the core stability muscles. Individuals are asked to flex the trunk while the knees are flexed in the supine position. The number of repetitions they can do for 30 seconds is recorded.'}, {'measure': 'Modified "Push-ups" test', 'timeFrame': 'baseline', 'description': 'This test is used to evaluate the strength of the core stability muscles. Individuals are asked to raise their body up by extending their elbows while in the prone position. The number of repetitions they can do for 30 seconds is recorded.'}, {'measure': 'Lateral bridge test', 'timeFrame': 'baseline', 'description': 'This test is used to evaluate the endurance of the core stability muscles. Individuals are asked to lift their bodies on their forearms and toes in the side-lying position and maintain this position. The time held in the position is recorded. The test is done separately for the right and left sides.'}, {'measure': 'Modified "Biering-Sorensen" trunk extension test', 'timeFrame': 'baseline', 'description': 'This test is used to evaluate the endurance of the core stability muscles. In the prone position, individuals are asked to hang their upper body over the edge of the bed and slightly extend them while their ankles are supported. The time held in the position is recorded.'}, {'measure': 'Trunk flexion test', 'timeFrame': 'baseline', 'description': 'This test is used to evaluate the endurance of the core stability muscles. Individuals are asked to stand with their torso at 60º with the floor, and their knees and hips at 90º. The time held in the position is recorded.'}, {'measure': '"Prone Bridge" test', 'timeFrame': 'baseline', 'description': 'This test is used to evaluate the endurance of the core stability muscles.Individuals are asked to lift their torso up in the prone position while the elbows are flexed, carrying their body weight on their forearms and toes. The time held in the position is recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'disability level', 'trunk control'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Trunk control disorders are frequently encountered in individuals with MS. Trunk control is very important for safe and quality movement. Impairment of trunk control reduces the level of independence of individuals during activities of daily living. For this reason, it is extremely important to evaluate the trunk in the examination and treatment of individuals. When the literature was examined, it was seen that studies examining trunk control were insufficient. Therefore, our study was planned to investigate the relationship between disability level and trunk control in individuals with MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population of the study will consist of patients who applied to the Neurology Outpatient Clinic for outpatient treatment and were diagnosed with Multiple Sclerosis by a neurologist and volunteered to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 18-65\n* Having a definite diagnosis of MS\n* Expanded Disability Status Scale (EDSS) score of 8.5 and below\n* Not having an attack in the last 3 months\n\nExclusion Criteria:\n\n* Having another musculoskeletal, cardiovascular, pulmonary, metabolic, or neurological disease severe enough to preclude participation in the study.\n* Having severe vision and hearing problems\n* The presence of severe cognitive impairment detected by the physician at a level that prevents the tests from being performed.'}, 'identificationModule': {'nctId': 'NCT05634993', 'briefTitle': 'Disability Level and Trunk Control in Individuals With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Relationship Between Disability Level and Trunk Control in Individuals With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '2022-42'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MS Group', 'interventionNames': ['Other: Assessment']}], 'interventions': [{'name': 'Assessment', 'type': 'OTHER', 'description': 'Assessment of disability level and trunk control', 'armGroupLabels': ['MS Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bandırma', 'state': 'Balıkesir', 'country': 'Turkey (Türkiye)', 'facility': 'Melike Sumeyye Ozen', 'geoPoint': {'lat': 40.35222, 'lon': 27.97667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bandırma Onyedi Eylül University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Melike Sumeyye Ozen', 'investigatorAffiliation': 'Hacettepe University'}}}}