Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-27 @ 10:01 AM
Study NCT ID:
NCT01780792
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2012-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examining the Effects of Video-game Exercise on Mobility and Brain Plasticity 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2012-11-07', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': 'after 8 weeks', 'description': 'The Berg Balance scale consists of 14 functional activities that test static and dynamic balance. Each item is scored on a scale of 0-4 with higher scores indicating better balance'}, {'measure': 'PASAT', 'timeFrame': 'after 8 weeks', 'description': 'The PASAT is a measure of sustained attention, working memory and information processing speed.'}], 'secondaryOutcomes': [{'measure': '4 square step test', 'timeFrame': 'after 8 weeks', 'description': 'requires a person to step rapidly in a multi-directional pattern over a cane. It predicts fallers'}, {'measure': 'The Activities Specific Balance Confidence Scale', 'timeFrame': 'after 8 weeks', 'description': 'Measures fear of falling. Subjects rate their balance confidence on 10 items.'}, {'measure': 'GAITRite', 'timeFrame': 'after 8 weeks', 'description': 'individuals walk on a computerized carpet that records spatiotemporal aspects of gait such as velocity and stride length.'}, {'measure': '6 minute walk test', 'timeFrame': 'Immediately prior to starting the intervention/control period,, after 8 week intervention/control period and then at an 8 week follow up', 'description': 'subjects walk for 6 minutes and distance walked is measured'}, {'measure': 'physical activity', 'timeFrame': 'after 8 weeks', 'description': 'subjects wear an accelerometer for 5 days which records how active they are.'}, {'measure': 'multiple sclerosis quality of life inventory', 'timeFrame': 'after 8 weeks', 'description': 'the MS quality of life inventory is filled out to measure the impact of MS on the individuals quality of life.'}, {'measure': 'fMRI', 'timeFrame': 'after 8 weeks', 'description': 'individuals will go into an MRI and undergo neuropsychological and motor testing to examine for neuroplasticity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'mobility', 'cognition', 'neuroplasticity', 'videogame play'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with multiple sclerosis (MS). It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive training, is an ideal intervention for improving cognitive functioning in those with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly specific exercise intervention to improve mobility and cognition among individuals with MS.', 'detailedDescription': 'Dance Dance Revolution (DDR) may offer an innovative and highly effective format for delivering exercise programs to people with MS. It is a fun, engaging and interactive video game that requires players to move their feet to targets while matching the rhythm of a song. In addition, DDR, involving both aerobic exercise and cognitive training, is an ideal intervention for improving cognitive functioning in those with MS. The purpose of this pilot study is to examine the use of DDR as a novel and highly specific exercise intervention to improve mobility and cognition among individuals with MS. We will be guided by the following three specific aims and hypotheses:\n\nSpecific Aim 1: Determine if an eight-week exercise program administered using DDR improves dynamic balance in people with MS relative to a wait-list control group.\n\nHypothesis 1: Dynamic balance as measured by the Berg Balance Scale will be more improved with the DDR intervention than the wait-list control group.\n\nSpecific Aim 2: Determine if the DDR intervention, combining fitness and cognitive training, over the course of an eight-week intervention, will have a more positive effect on domains of processing speed and executive control, than a wait-list control group.\n\nHypothesis 2: The DDR group relative to the wait-list control group, will show significant improvement in cognitive functioning as assessed by the Paced Auditory Serial Addition Test (PASAT), a measure of processing speed, and executive functioning. Specifically, we hypothesize that given severe deficits in processing speed and executive control, participation in a DDR intervention, will result in a significant improvement on the PASAT, a widely used measure to assess cognitive functioning in patients with MS.\n\nSpecific Aim 3: We will also examine whether improvements in cognitive processes engendered by DDR on the PASAT will be supported by changes in underlying neural circuits, as inferred from patterns of event-related functional magnetic resonance imaging (fMRI) activation obtained in a 3 Tesla scanner.\n\nHypothesis 3: Improvements in cognition as indexed by higher accuracy scores and faster reaction time on the PASAT, will be accompanied by a change in the recruitment of underlying neural processes as inferred from functional magnetic resonance imaging. MS participants in the DDR group will show an increase in recruitment of the attentional network, and more specifically the prefrontal and parietal cortices, cortical regions responsible for successful performance on the PASAT task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Expanded Disability Status Score of \\< 5 and a diagnosis of relapsing-remitting multiple sclerosis\n\nExclusion Criteria:\n\n* other neurological or orthopedic diagnosis that limits ambulation, age 30-59'}, 'identificationModule': {'nctId': 'NCT01780792', 'briefTitle': 'Examining the Effects of Video-game Exercise on Mobility and Brain Plasticity in Individuals With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Examining the Effects of Dance, Dance Revolution on Mobility, Brain Plasticity and Cognition in Individuals With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '2011H0048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dance Dance Revolution game play', 'description': 'Dance Dance Revolution video game play', 'interventionNames': ['Other: Dance Dance Revolution video game play']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'individuals continue usual care for 8 weeks'}], 'interventions': [{'name': 'Dance Dance Revolution video game play', 'type': 'OTHER', 'description': 'Individuals play dance dance revolution 3 times a week for 8 weeks', 'armGroupLabels': ['Dance Dance Revolution game play']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Atwell Hall', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Deb Kegelmeyer, DPT, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'Ruchika Prakash, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'Anne Kloos, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ruchika Prakash', 'investigatorAffiliation': 'Ohio State University'}}}}