Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-30 @ 12:07 AM
Study NCT ID:
NCT04550650
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2020-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postural instability', 'timeFrame': '2 years', 'description': 'Body sway (mm) (Posturography test)'}, {'measure': 'EQ-5D quality of life', 'timeFrame': '2 years', 'description': 'EQ-5D (EQ-5D was first introduced in 1990 by the EuroQol Group, The EQ-5D questionnaire is made up for two components; health state description and evaluation)'}, {'measure': 'balance test', 'timeFrame': '2 years', 'description': 'Berg Balance test (The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks, 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )'}, {'measure': 'mobility test', 'timeFrame': '2 years', 'description': 'Six minutes walk test (6MWT) (m) (The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway)'}, {'measure': 'depression scale', 'timeFrame': '2 years', 'description': 'Beck Depression scale (The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression, 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression)'}, {'measure': 'MSIS-29', 'timeFrame': '2 years', 'description': 'Multiple Sclerosis Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'posture', 'neurorehabilitation', 'balance'], 'conditions': ['Multiple Sclerosis, Chronic Progressive', 'Multiple Sclerosis, Primary Progressive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/?term=MS+rehabilitation', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Different therapies can improve clinical and motor symptoms of multiple sclerosis (MS) similarly, but studies comparing the effects of different exercise therapies on clinical and motor outcomes are scant. We compared the effects of exergaming (EXE), balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group (CON) on clinical and motor symptoms and quality of life (QoL) in people with MS (PwMS).\n\nMethods: PwMS (n = 68, 90% female; age, 47.0 yr; Expanded Disability Status Scale score 5-6) were randomized into five groups. Before and after the interventions (five times a week for 5 wk), PwMS were tested for MS-related clinical and motor symptoms (Multiple Sclerosis Impact Scale-29 (MSIS-29), primary outcome), QoL (EuroQol Five Dimensions Questionnaire), symptoms of depression, gait and balance ability (Tinetti Assessment Tool), static and dynamic balance and fall risk (Berg Balance Scale), walking capacity (6-min walk test), and standing posturography on a force platform.\n\nPatients were followed up for 2 years after 5 weeks of intensive care. Tests are performed every six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple Sclerosis\n* instability problem\n\nExclusion Criteria:\n\n• Severe heart problems, severe demeanor, alcoholism, drug problems'}, 'identificationModule': {'nctId': 'NCT04550650', 'briefTitle': 'Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Somogy Megyei Kaposi Mór Teaching Hospital'}, 'officialTitle': 'Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients', 'orgStudyIdInfo': {'id': 'IKEB2020/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Controll', 'description': 'No intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Training grp', 'description': 'Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training', 'interventionNames': ['Other: Training groupe']}, {'type': 'EXPERIMENTAL', 'label': 'PNF', 'description': '2 years long, You have only treated patients with the PNF technique.', 'interventionNames': ['Other: PNF']}, {'type': 'EXPERIMENTAL', 'label': 'Spinning group', 'description': 'Patients developed endurance for 2 years. They worked using a spinning bike.', 'interventionNames': ['Other: Spinning grp']}, {'type': 'EXPERIMENTAL', 'label': 'Balance', 'description': 'Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance', 'interventionNames': ['Other: Balance']}], 'interventions': [{'name': 'Training groupe', 'type': 'OTHER', 'description': 'Using virtual training', 'armGroupLabels': ['Training grp']}, {'name': 'PNF', 'type': 'OTHER', 'description': 'PNF technique was used', 'armGroupLabels': ['PNF']}, {'name': 'Spinning grp', 'type': 'OTHER', 'description': 'They only worked with spinning bikes.', 'armGroupLabels': ['Spinning group']}, {'name': 'Balance', 'type': 'OTHER', 'description': 'Balance development was done', 'armGroupLabels': ['Balance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Kaposvár', 'state': 'Somogy County', 'country': 'Hungary', 'facility': 'Somogy Megyei Kaposi Mór Oktató Kórház', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Somogy Megyei Kaposi Mór Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. József Tollár, Head of Neurorehabilitation ,7400 Kaposvár, Tallián Gy. u 20-32', 'investigatorFullName': 'Tollár József', 'investigatorAffiliation': 'Somogy Megyei Kaposi Mór Teaching Hospital'}}}}