Pediatric Onset Multiple Sclerosis (POMS)
Conditions
Keywords
Multiple Sclerosis, Cognitive Impairment, Physical activity
Brief summary
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).
Interventions
DEVICEVR 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
BEHAVIORALEducational 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.
BEHAVIORALStandard Management of Physical Activity
Routine discussion of lifestyle factors including physical activity during clinic visits
Sponsors
Microsoft Corporation
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of Pediatric-Onset MS (\<18 years) according to the 2017 revised McDonald criteria (relapsing-remitting) * Expanded Disability Status Scale (EDSS) ≤ 5.0 * Relapse free for the past 30 days (including no corticosteroids) * No contraindications to physical activity, including pregnancy * Participant and parent (if between 15 and 18 years of age) written informed consent.
Exclusion criteria
* History of visual provoked seizures * EDSS \> 5.0
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) | 3 months | A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score. |
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning Test - II (CVLT-II) | 3 months | A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80). |
| Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised | 3 months | A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance Walked as Assessed by the Six Minute Walk Test (6MWT) | 6 months | the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded |
| Number of Clinical Relapses | 12 months | Assessment at each clinic visit |
| Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) | 3 Month | 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. |
| 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. | 1 month | — |
| Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire | 6 months | — |
| New Activity on MRI (T2 Lesions, Gd+) | 12 months | Assessment at each MRI |
| Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS) | 3 months | 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. |
| Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS) | 3 month | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Participants The enrolled participants were lost to follow up before being assigned to any intervention. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 19 years STANDARD_DEVIATION 0 |
| Anxiety and Depression and Indicated by Score on the Hospital Anxiety and Depression Scale (HADS) | 11 score on a scale STANDARD_DEVIATION 0 |
| Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) | 29 score on a scale STANDARD_DEVIATION 4.2 |
| Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II | 61.5 score on a scale STANDARD_DEVIATION 7.78 |
| Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) | 61 score on a scale STANDARD_DEVIATION 2.8 |
| Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) | 75 score on a scale STANDARD_DEVIATION 0 |
| Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 | 108 score on a scale STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Population: Data for this outcome measure were not collected from any participant.
Primary
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
Population: Data for this outcome measure were not collected from any participant.
Primary
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
Population: Data for this outcome measure were not collected from any participant.
Primary
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: 12 months
Population: Data for this outcome measure were not collected from any participant.
Primary
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
Population: Data for this outcome measure were not collected from any participant.
Primary
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
Population: Data for this outcome measure were not collected from any participant.
Primary
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
Population: Data for this outcome measure were not collected from any participant.
Primary
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
Population: Data for this outcome measure were not collected from any participant.
Primary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire
Time frame: 6 months
Population: Data for this outcome measure were not collected from any participant.
Secondary
Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire
Time frame: 12 months
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
New Activity on MRI (T2 Lesions, Gd+)
Assessment at each MRI
Time frame: 12 months
Population: Data for this outcome measure were not collected from any participant.
Secondary
Number of Clinical Relapses
Assessment at each clinic visit
Time frame: 12 months
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.
Secondary
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
Population: Data for this outcome measure were not collected from any participant.