Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT04750733
Status:
COMPLETED
Last Update Posted:
2022-07-08
First Post:
2021-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Core Performance on Functional Parameters in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2021-02-07', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core strength', 'timeFrame': 'Baseline', 'description': 'Core strength will be evaluated within the scope of core assessment. Curl-Up and Modified Push-Up test will be used for the evaluation of core strength.'}, {'measure': 'Core endurance', 'timeFrame': 'Baseline', 'description': 'Core endurance will be evaluated within the scope of core assessment. Trunk flexor, extensor, lateral endurance and plank will be used in the evaluation of core endurance and recorded as seconds.'}, {'measure': 'Postural sway', 'timeFrame': 'Baseline', 'description': 'Postural sways will be evaluated with biodex balance system in different condition such as open eyes on firm and foam surface, closed eyes on firm and foam surface, double stance on firm and foam surface, tandem stance on firm and foam surface.'}, {'measure': 'İsokinetic strength', 'timeFrame': 'Baseline', 'description': 'Concentric isokinetic muscle strength of the knee flexor and extensor muscles will be evaluated with Biodex isokinetic dynamometer at angular velocities of 30,60 and 90°/s.'}], 'secondaryOutcomes': [{'measure': 'Physical capacity', 'timeFrame': 'Baseline', 'description': 'Two-minute walk test (2-MWT) will be used to evaluate the mobility of the people with MS. 2-MWT is a measure of self-paced walking ability and functional capacity.'}, {'measure': 'Mobility', 'timeFrame': 'Baseline', 'description': 'Timed Up and Go (TUG) will be used. TUG is a test used to determine fall risk and measure the progress of balance, sit to stand and walking.'}, {'measure': 'Fatigue', 'timeFrame': 'Baseline', 'description': 'Fatigue Severity Scale (FSS) will be used to evaluate fatigue levels. This scale evaluates the severity of fatigue with 9 questions. Each question scores between 1 (I do not agree) and 7 (fully agree). The FSS score is the average value of nine sections. A high score indicates increased fatigue severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'core stability', 'postural control', 'isokinetic strength', 'physical capacity', 'fatigue'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Optimal trunk control relies on somatosensory, motor and musculoskeletal integrity, which is often damaged in multiple sclerosis (MS). Researches on postural control in people with MS (PwMS) have revealed that reduced somatosensory conduction may adversely affect some functions. PwMS have increased postural sway in upright posture than healthy people. They move closer and slower when reaching out or taking a step. Trunk controls are weak and postural responses are delayed. The activation of core muscles is very important for an effective trunk control. Because the core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements. The decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body. There are a limited number of studies in the literature showing that core stability is reduced in PwMS. Our knowledge about the effects of this reduction on function in PwMS is very limited.', 'detailedDescription': 'The aim of this study is to evaluate core strength and endurance and determine its effect on postural control, knee muscle strength, physical capacity and fatigue parameters in individuals with MS. Also relationship between these parameters will investigate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People with MS followed in the Neurology Department of Bakirkoy Prof. Dr. Mazhar Osman Education and Research Hospital for Psychiatric and Neurological Diseases will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being diagnosed with MS according to McDonald's criteria\n* Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score\n* No attacks during the last 3 months\n* Being an ambulatory\n* Volunteering to participate in the study\n\nExclusion Criteria:\n\n* Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes\n* Doing regular sports\n* Being involved in another physiotherapy and rehabilitation program related to MS"}, 'identificationModule': {'nctId': 'NCT04750733', 'briefTitle': 'Impact of Core Performance on Functional Parameters in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Impact of Core Performance on Functional Parameters in Multiple Sclerosis', 'orgStudyIdInfo': {'id': '59491012-604.01.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple Sclerosis', 'description': 'Ambulatory MS patients', 'interventionNames': ['Other: Assessment']}], 'interventions': [{'name': 'Assessment', 'type': 'OTHER', 'description': 'Assessment of core strength and endurance, muscle strength, postural sway in different condition, physical capacity and fatigue', 'armGroupLabels': ['Multiple Sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist, Research Assistant', 'investigatorFullName': 'Feray Güngör', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}