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出境医 / 临床实验 / Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)

Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)

Study Description
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).

Condition or disease Intervention/treatment Phase
Pediatric Onset Multiple Sclerosis (POMS) Device: VR active video game intervention Behavioral: Educational session Behavioral: Standard Management of Physical Activity Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-onset Multiple Sclerosis
Actual Study Start Date : May 10, 2019
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Exercise Group Device: 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

Behavioral: Educational 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.
Active Comparator: Control Group Behavioral: Standard Management of Physical Activity
Routine discussion of lifestyle factors including physical activity during clinic visits
Outcome Measures
Primary Outcome Measures :
  1. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) [ Time Frame: Baseline ]
    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

  2. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) [ Time Frame: 3 months ]
    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

  3. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) [ Time Frame: 6 months ]
    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

  4. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) [ Time Frame: 12 months ]
    A measure of sustained attention, working memory and information processing speed. The outcome measure is a numerical score.

  5. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II (CVLT-II) [ Time Frame: Baseline ]
    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

  6. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II (CVLT-II) [ Time Frame: 3 months ]
    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

  7. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II (CVLT-II) [ Time Frame: 6 months ]
    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

  8. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - California Verbal Learning test - II (CVLT-II) [ Time Frame: 12 months ]
    A measure of verbal memory (immediate recall) including the first 5 recall trials. The outcome measure is a numerical score (.../80).

  9. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: Baseline ]
    A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).

  10. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: 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).

  11. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: 6 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).

  12. Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: 12 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 Outcome Measures :
  1. Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: baseline ]
    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.

  2. Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 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.

  3. Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 6 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.

  4. Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 12 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.

  5. Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: Baseline ]
    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.

  6. Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: 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.

  7. Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: 6 month ]
    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.

  8. Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: 12 month ]
    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.

  9. Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline ]
    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.

  10. Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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.

  11. Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 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.

  12. Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 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.

  13. Distance walked as assessed by the Six Minute walk Test(6MWT) [ Time Frame: Baseline ]
    the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded

  14. Distance walked as assessed by the Six Minute walk Test(6MWT) [ Time Frame: 6 months ]
    the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded

  15. Distance walked as assessed by the Six Minute walk Test(6MWT) [ Time Frame: 12 months ]
    the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded

  16. Number of clinical relapses [ Time Frame: 12 months ]
    Assessment at each clinic visit

  17. New activity on MRI (T2 lesions, Gd+) [ Time Frame: 12 months ]
    Assessment at each MRI

  18. 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 ]
  19. 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 ]
  20. 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 ]
  21. Degree of incorporation of physical activity into daily life as assessed by a self report questionnaire [ Time Frame: 6 months ]
  22. Degree of incorporation of physical activity into daily life as assessed by a self report questionnaire [ Time Frame: 12 months ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
United States, Texas
The University of Texas Health Science Center,Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Microsoft Houston
Investigators
Layout table for investigator information
Principal Investigator: Stephanie Garcia-Tarodo, MD The University of Texas Health Science Center, Houston
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date April 22, 2021
Actual Study Start Date  ICMJE May 10, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) [ Time Frame: Baseline ]
    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) - Symbol Digit Modalities Test (SDMT) [ Time Frame: 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) - Symbol Digit Modalities Test (SDMT) [ Time Frame: 6 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) - Symbol Digit Modalities Test (SDMT) [ Time Frame: 12 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) [ Time Frame: Baseline ]
    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) - California Verbal Learning test - II (CVLT-II) [ Time Frame: 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) - California Verbal Learning test - II (CVLT-II) [ Time Frame: 6 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) - California Verbal Learning test - II (CVLT-II) [ Time Frame: 12 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 [ Time Frame: Baseline ]
    A measure of visuo-spatial learning and delayed recall, using the first 3 recall trials. The outcome measure is a numerical total score (.../12).
  • Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: 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).
  • Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: 6 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).
  • Cognitive disability as assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Brief Visuospatial Memory Test (BVMT) - Revised [ Time Frame: 12 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: baseline ]
    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.
  • Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 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.
  • Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 6 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.
  • Physical and psychological impact of MS as assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 12 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.
  • Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: Baseline ]
    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.
  • Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: 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.
  • Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: 6 month ]
    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.
  • Fatigue as assessed by the Modified Fatigue Impact Scale (MFIS) [ Time Frame: 12 month ]
    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) [ Time Frame: Baseline ]
    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.
  • Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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.
  • Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 6 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.
  • Anxiety and depression as assessed by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 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.
  • Distance walked as assessed by the Six Minute walk Test(6MWT) [ Time Frame: Baseline ]
    the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded
  • Distance walked as assessed by the Six Minute walk Test(6MWT) [ Time Frame: 6 months ]
    the participant is instructed to walk for six minutes as quickly and safely as possible and the distance covered will be recorded
  • Distance walked as assessed by the Six Minute walk Test(6MWT) [ Time Frame: 12 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 [ Time Frame: 12 months ]
    Assessment at each clinic visit
  • New activity on MRI (T2 lesions, Gd+) [ Time Frame: 12 months ]
    Assessment at each MRI
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)
Official Title  ICMJE Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-onset Multiple Sclerosis
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Onset Multiple Sclerosis (POMS)
Intervention  ICMJE
  • Device: 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
  • Behavioral: Educational 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.
  • Behavioral: Standard Management of Physical Activity
    Routine discussion of lifestyle factors including physical activity during clinic visits
Study Arms  ICMJE
  • Experimental: Exercise Group
    Interventions:
    • Device: VR active video game intervention
    • Behavioral: Educational session
  • Active Comparator: Control Group
    Intervention: Behavioral: Standard Management of Physical Activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 12, 2021) 		2
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2019) 		24
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03933020
Other Study ID Numbers  ICMJE HSC-MS-19-0247
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rohini Samudralwar, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Microsoft Houston
Investigators  ICMJE
Principal Investigator: Stephanie Garcia-Tarodo, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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