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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise
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.
Routine discussion of lifestyle factors including physical activity during clinic visits
The University of Texas Health Science Center,Houston
Houston, Texas, United States
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.
Time frame: 3 months
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.
Time frame: 6 months
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)
A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.
Time frame: 12 months
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)
A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).
Time frame: 3 months
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)
A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).
Time frame: 6 months
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II)
A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).
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Time frame: 12 months
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised
A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).
Time frame: 3 months
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised
A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).
Time frame: 6 months
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised
A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).
Time frame: 12 months
Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
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.
Time frame: 3 Month
Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
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.
Time frame: 6 month
Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
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.
Time frame: 12 month
Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)
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.
Time frame: 3 months
Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)
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.
Time frame: 6 month
Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)
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.
Time frame: 12 month
Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
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.
Time frame: 3 month
Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
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.
Time frame: 6 month
Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
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.
Time frame: 12 month
Distance Walked as Assessed by the Six Minute Walk Test (6MWT)
the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded
Time frame: 6 months
Distance Walked as Assessed by the Six Minute Walk Test (6MWT)
the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded
Time frame: 12 months
Number of Clinical Relapses
Assessment at each clinic visit
Time frame: 12 months
New Activity on MRI (T2 Lesions, Gd+)
Assessment at each MRI
Time frame: 12 months
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.
Time frame: 1 month
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.
Time frame: 3 month
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.
Time frame: 6 month
Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire
Time frame: 6 months
Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire
Time frame: 12 months