Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT03497468
Status:
UNKNOWN
Last Update Posted:
2018-04-13
First Post:
2018-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional capacity', 'timeFrame': '6 weeks', 'description': 'Change from baseline functional capacity with six minute walking test'}], 'secondaryOutcomes': [{'measure': 'dynamic gait skills', 'timeFrame': '6 weeks', 'description': 'Change from baseline functional mobility with dynamic gait index'}, {'measure': 'limitation of gait', 'timeFrame': '6 weeks', 'description': 'Change from baseline functional mobility with MS walking scale-12'}, {'measure': 'dynamic balance and fall risk', 'timeFrame': '6 weeks', 'description': 'Change from baseline functional mobility with timed up and go test'}, {'measure': 'sitatic balance', 'timeFrame': '6 weeks', 'description': 'Change from baseline balance with functional reach test'}, {'measure': 'dynamic balance', 'timeFrame': '6 weeks', 'description': 'Change from baseline balance with berg balance scale'}, {'measure': 'severity of fatigue', 'timeFrame': '6 weeks', 'description': 'Change from baseline fatigue with fatigue severity scale'}, {'measure': 'impact of fatigue', 'timeFrame': '6 weeks', 'description': 'Change from baseline fatigue with fatigue impact scale'}, {'measure': 'Quality of life', 'timeFrame': '6 weeks', 'description': 'Change from baseline quality of life with MS quality of life instrument-54'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['task-oriented training', 'exercise training', 'mobility', 'balance', 'fatigue', 'quality of life'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'descriptionModule': {'briefSummary': "Multiple Sclerosis (MS) is inflammatory, demyelinating and autoimmune disease of the central nervous system. It is usually seen with relapses and genetic and environmental factors play a role in the etiology. Neurological symptoms seen in MS restrict the patient's daily activity and social role participation. Mobility problems and fatigue are the most important reasons of role limitations and decreased quality of life. The importance of exercise training in disease management has been emphasized in recent years. However, few studies have investigated the effects of task-oriented trainings on symptoms of the disease. The aim of this sudy is to investigate the effects of task-oriented training additional to combined exercise training on functional capacity, mobility, balance, fatigue and quality of life in patients with MS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple Sclerosis diagnosis\n* Expanded Disability Status Scale \\> 5,5\n* No cognitive problems\n* No relapses in the last 3 months\n* No other neurological or chronic disease\n\nExclusion Criteria:\n\n* Relapse during the intervention\n* Exercise intolerance'}, 'identificationModule': {'nctId': 'NCT03497468', 'briefTitle': 'Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'kunal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients in this group will receive combined exercise training included aerobic and strengthening exercises, 3 times a week for 6 weeks. All exercise sessions will be performed under the supervision of a physiotherapist.', 'interventionNames': ['Other: Combined exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'Training group', 'description': 'Patients in this group will receive task-oriented training additional to combined exercise training 3 times a week for 6 weeks. Task-oriented training included more functional daily life mobility activities like reaching, obstacle walking, stairs climbing. All exercise sessions will be performed under the supervision of a physiotherapist.', 'interventionNames': ['Other: Task-oriented training']}], 'interventions': [{'name': 'Combined exercise training', 'type': 'OTHER', 'description': 'Aerobic training with cycle ergometer %60-80 of maximal Heart Rate, submaximal level, strengthening of the major muscles of upper and lower extremities', 'armGroupLabels': ['Control group']}, {'name': 'Task-oriented training', 'type': 'OTHER', 'description': 'Functional reaching, walking on different obstacles and floor,sitting and standing on different levels and surface,walking around obstacle, climbing stairs with different height and surface', 'armGroupLabels': ['Training group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kamer Unal-Eren, PT, PhD', 'role': 'CONTACT', 'email': 'kamerunals@yahoo.com', 'phone': '+902125232288', 'phoneExt': '4650'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, PhD, PT', 'investigatorFullName': 'Kamer Unal', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}