Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT03933020
Status:
TERMINATED
Last Update Posted:
2022-05-19
First Post:
2019-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Rohini.D.Samudralwar@uth.tmc.edu', 'phone': '(832) 325-7077', 'title': 'Rohini D. Samudralwar, MD', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'not collected', 'description': 'Both participants were lost to follow up after the time of enrollment, before the intervention was assigned, and before any adverse events could be assessed; therefore, adverse were not monitored or assessed for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'The enrolled participants were lost to follow up before being assigned to any intervention.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'Virtual reality (VR) active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '3 months', 'description': 'A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'PRIMARY', 'title': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '6 months', 'description': 'A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'PRIMARY', 'title': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '12 months', 'description': 'A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'PRIMARY', 'title': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '3 months', 'description': 'A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'PRIMARY', 'title': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '6 months', 'description': 'A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'PRIMARY', 'title': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '12 months', 'description': 'A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'PRIMARY', 'title': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '3 months', 'description': 'A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'PRIMARY', 'title': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '6 months', 'description': 'A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'PRIMARY', 'title': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '12 months', 'description': 'A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '3 Month', 'description': "29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '6 month', 'description': "29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '12 month', 'description': "29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '3 months', 'description': '21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '6 month', 'description': '21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '12 month', 'description': '21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '3 month', 'description': '14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '6 month', 'description': '14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '12 month', 'description': '14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Distance Walked as Assessed by the Six Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '6 months', 'description': 'the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Distance Walked as Assessed by the Six Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '12 months', 'description': 'the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Number of Clinical Relapses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '12 months', 'description': 'Assessment at each clinic visit', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'New Activity on MRI (T2 Lesions, Gd+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '12 months', 'description': 'Assessment at each MRI', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '1 month', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '3 month', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '6 month', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '6 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}, {'type': 'SECONDARY', 'title': 'Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Group', 'description': 'VR active video game intervention: The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise\n\nEducational session: This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard Management of Physical Activity: Routine discussion of lifestyle factors including physical activity during clinic visits'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure were not collected from any participant.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'The enrolled participants were lost to follow up before being assigned to any intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'Received an Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The 2 enrolled participants were lost to follow up before they were assigned to an intervention; therefore, no participants "started" per the ClinicalTrials.gov definition of "started," which is "the number of participants assigned to each arm or group."'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'The enrolled participants were lost to follow up before being assigned to any intervention.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'After searching all records and contacting all team members, the age of one of the participants was not able to be determined.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'spread': '2.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Brief International Cognitive Assessment for MS (BICAMS) Symbol Digit Modalities Test (SDMT) is a measure of sustained attention, working memory, and information processing speed. It consists of single digits paired with abstract symbols. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 seconds. The score is reported as the number correct over the 90-second time span, and possible score ranges from 0 to 120, with a higher score indicating a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61.5', 'spread': '7.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The examiner reads a list of 16 words at a slightly slower rate than one item per second. Participants listen to the list and then report as many of the words as possible. After the first recall, the entire list is read again in the same order followed by a second attempt at recall. Altogether, there are five learning trials. The measure is reported as the total words recalled over trials 1 to 5. Total score ranges from 0 to 80, with a higher score indicating a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'spread': '4.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'In this test, six abstract designs (in a 2 x 3 array) are presented for 10 seconds. The display is then removed from view and participants are required to draw the 2 x 3 array of figures from memory, with the correct shapes in the correct position. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials and the outcome measure is the total number of points earned over the three trials. Total score ranges from 0 to 36, with a higher score indicating a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Anxiety and Depression and Indicated by Score on the Hospital Anxiety and Depression Scale (HADS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Total score ranges from 0 to 42, with a higher score indicating greater anxiety and depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data for this outcome measure were collected from only 1 participant.'}, {'title': 'Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '108', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Total score on the Multiple Sclerosis Impact Scale-29 (MSIS-29) ranges from 29-145, with a higher score indicating a greater impact of multiple sclerosis on day to day life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data for this outcome measure were only collected from 1 participant.'}, {'title': 'Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '75', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Total score on the MFIS ranges from 0 to 84, with a higher score indicating greater impact of fatigue on functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data for this outcome measure were collected for only 1 participant.'}], 'populationDescription': 'Baseline data were collected before the participants were assigned to an intervention, and the 2 enrolled participants were lost to follow up before they were assigned to an intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-24', 'size': 429953, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-13T16:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Lack of patient interest in participating (for adult patients), and lack of parental consent to participate (for pediatric patients)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'dispFirstSubmitDate': '2021-04-12', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2019-04-24', 'dispFirstSubmitQcDate': '2022-05-17', 'resultsFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2019-04-26', 'dispFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-17', 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)', 'timeFrame': '3 months', 'description': 'A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.'}, {'measure': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)', 'timeFrame': '6 months', 'description': 'A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.'}, {'measure': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)', 'timeFrame': '12 months', 'description': 'A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.'}, {'measure': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)', 'timeFrame': '3 months', 'description': 'A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).'}, {'measure': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)', 'timeFrame': '6 months', 'description': 'A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).'}, {'measure': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)', 'timeFrame': '12 months', 'description': 'A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).'}, {'measure': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised', 'timeFrame': '3 months', 'description': 'A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).'}, {'measure': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised', 'timeFrame': '6 months', 'description': 'A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).'}, {'measure': 'Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised', 'timeFrame': '12 months', 'description': 'A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).'}], 'secondaryOutcomes': [{'measure': 'Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)', 'timeFrame': '3 Month', 'description': "29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145."}, {'measure': 'Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)', 'timeFrame': '6 month', 'description': "29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145."}, {'measure': 'Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)', 'timeFrame': '12 month', 'description': "29-item self-report measuring the physical and psychological impact of MS from the patient's perspective during the previous 2 weeks. The assessment consists of 29 statements, each scored between 1 (not at all) and 5 (extremely), with a total score between 29 and 145."}, {'measure': 'Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)', 'timeFrame': '3 months', 'description': '21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.'}, {'measure': 'Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)', 'timeFrame': '6 month', 'description': '21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.'}, {'measure': 'Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)', 'timeFrame': '12 month', 'description': '21-item self-report measuring the impact of fatigue on physical, cognitive and psychosocial aspects of MS during the previous 4 weeks. The assessment contains 21 statements, each scored between 0 (never) and 4 (almost always). Items can be aggregated into three subscales (physical, cognitive, and psychosocial) as well as into a total MFIS score. The physical subscale can range from 0 to 36. The cognitive subscale can range from 0 to 40. The psychosocial subscale can range from 0 to 8. The total MFIS score can range from 0 to 84.'}, {'measure': 'Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '3 month', 'description': '14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.'}, {'measure': 'Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '6 month', 'description': '14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.'}, {'measure': 'Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '12 month', 'description': '14-item self-report measuring the degree of anxiety and depression in participants during the previous week. The assessment contains 14 statements, each scored between 3 (most of the time) and 0 (not at all). The score can be subdivided into a Depression scale that can range from 0 to 21, and an Anxiety scale, that can range from 0 to 21.'}, {'measure': 'Distance Walked as Assessed by the Six Minute Walk Test (6MWT)', 'timeFrame': '6 months', 'description': 'the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded'}, {'measure': 'Distance Walked as Assessed by the Six Minute Walk Test (6MWT)', 'timeFrame': '12 months', 'description': 'the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded'}, {'measure': 'Number of Clinical Relapses', 'timeFrame': '12 months', 'description': 'Assessment at each clinic visit'}, {'measure': 'New Activity on MRI (T2 Lesions, Gd+)', 'timeFrame': '12 months', 'description': 'Assessment at each MRI'}, {'measure': 'Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries.', 'timeFrame': '1 month'}, {'measure': 'Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries.', 'timeFrame': '3 month'}, {'measure': 'Safety of Implementing a VR Active Video Game Program at Home as Assessed by the Number of Self-reported Incidents That Occur During the Exercise Sessions, Including Falls or Physical Injuries.', 'timeFrame': '6 month'}, {'measure': 'Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire', 'timeFrame': '6 months'}, {'measure': 'Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire', 'timeFrame': '12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Cognitive Impairment', 'Physical activity'], 'conditions': ['Pediatric Onset Multiple Sclerosis (POMS)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to to determine how implementing a home-based virtual reality video (VR) game exercise program in young people with Multiple Sclerosis(MS) can improve disability outcomes by measuring its impact on cognitive assessments (BICAMS), subjective measures of cognitive, physical and psychosocial disability, and motor assessments (6MWT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of Pediatric-Onset MS (\\<18 years) according to the 2017 revised McDonald criteria (relapsing-remitting)\n* Expanded Disability Status Scale (EDSS) ≤ 5.0\n* Relapse free for the past 30 days (including no corticosteroids)\n* No contraindications to physical activity, including pregnancy\n* Participant and parent (if between 15 and 18 years of age) written informed consent.\n\nExclusion Criteria:\n\n* History of visual provoked seizures\n* EDSS \\> 5.0'}, 'identificationModule': {'nctId': 'NCT03933020', 'briefTitle': 'Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-onset Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'HSC-MS-19-0247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Group', 'interventionNames': ['Device: VR active video game intervention', 'Behavioral: Educational session']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Behavioral: Standard Management of Physical Activity']}], 'interventions': [{'name': 'VR active video game intervention', 'type': 'DEVICE', 'description': 'The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise', 'armGroupLabels': ['Exercise Group']}, {'name': 'Educational session', 'type': 'BEHAVIORAL', 'description': 'This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.', 'armGroupLabels': ['Exercise Group']}, {'name': 'Standard Management of Physical Activity', 'type': 'BEHAVIORAL', 'description': 'Routine discussion of lifestyle factors including physical activity during clinic visits', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center,Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Stephanie Garcia-Tarodo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Microsoft Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rohini Samudralwar', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}