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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03933020

Recruitment Status Terminated (Lack of patient interest in participating (for adult patients), and lack of parental consent to participate (for pediatric patients))

First Posted May 1, 2019

Last update posted April 22, 2021

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:Pediatric Onset Multiple Sclerosis (POMS)
  • Intervention/Treatment: Device: VR active video game intervention
    Behavioral: Educational session
    Behavioral: Standard Management of Physical Activity
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: May 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
  • Ages Eligible for Study: 15 to 25 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Confirmed diagnosis of Pediatric-Onset MS ( 5.0

Contacts and Locations
Contacts
Locations

United States, Texas
The University of Texas Health Science Center,Houston
Houston

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Microsoft Houston

Investigators

Principal Investigator: Stephanie Garcia-Tarodo, MD The University of Texas Health Science Center, Houston

More Information
  • Responsible Party: The University of Texas Health Science Center, Houston
  • ClinicalTrials.gov Identifier: NCT03933020 History of Changes
  • Other Study ID Numbers: HSC-MS-19-0247
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: April 22, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by The University of Texas Health Science Center, Houston: Multiple Sclerosis
    Cognitive Impairment
    Physical activity
  • Additional relevant MeSH terms: Sclerosis Multiple Sclerosis