Pediatric Onset Multiple Sclerosis (POMS)NCT03933020
Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-Onset Multiple Sclerosis (POMS)
A study testing VR active video game intervention, Educational session and Standard Management of Physical Activity in people with Pediatric Onset Multiple Sclerosis (POMS), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Pediatric Onset Multiple Sclerosis (POMS)
- What is being tested?
- VR active video game intervention, Educational session and Standard Management of Physical Activity
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 31 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- History of visual provoked seizures
- EDSS > 5.0
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center,Houston
Houston, Texas, 77030
About this study
Official title: Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-onset Multiple Sclerosis
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).
- Being tested
- VR active video game intervention, Educational session, Standard Management of Physical Activity
- Keywords
- Multiple Sclerosis, Cognitive Impairment, Physical activity
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR active video game interventionDevice
The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise
Educational sessionBehavioural
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.
Standard Management of Physical ActivityBehavioural
Routine discussion of lifestyle factors including physical activity during clinic visits
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Not described Receives: Device: VR active video game intervention; Behavioral: Educational session |
| Control Group | Active comparator | Not described Receives: Behavioral: Standard Management of Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 months
Number of Clinical Relapses
Assessment at each clinic visit
Measured: 12 months
New Activity on MRI (T2 Lesions, Gd+)
Assessment at each MRI
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 month
Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire
Measured: 6 months
Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start10 May 2019
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: Lack of patient interest in participating (for adult patients), and lack of parental consent to participate (for pediatric patients)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric Onset Multiple Sclerosis (POMS)Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Microsoft Corporation
- Responsible party
- Principal investigator, Rohini Samudralwar, The University of Texas Health Science Center, Houston
- Investigators
- Stephanie Garcia-Tarodo, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933020
- Sponsor's protocol ID
- HSC-MS-19-0247
- Status last verified
- May 2022
- First submitted
- 24 Apr 2019
- Last updated
- 19 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Activity on Cognitive Outcomes in Youth With Pediatric-onset Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03933020
- Acronym / sponsor ID
- HSC-MS-19-0247
- Keywords
- Multiple Sclerosis, Cognitive Impairment, Physical activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient interest in participating (for adult patients), and lack of parental consent to participate (for pediatric patients)
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Microsoft Corporation
- Study start
- 10 May 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Posted 19 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Device: VR active video game intervention, Behavioral: Educational session |
| Control Group | Active comparator | Behavioral: Standard Management of Physical Activity |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- History of visual provoked seizures
- EDSS > 5.0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR active video game interventionThe Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise | Device | Exercise Group |
| Educational sessionThis 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. | Behavioural | Exercise Group |
| Standard Management of Physical ActivityRoutine discussion of lifestyle factors including physical activity during clinic visits | Behavioural | Control Group |
Primary outcome
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: 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: 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).
18 secondary outcomes
Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time frame: 3 Month
Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time frame: 6 month
Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)
Time frame: 12 month
Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)
Time frame: 3 months
Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)
Time frame: 6 month
Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)
Time frame: 12 month
Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 month
Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 month
Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 month
Distance Walked as Assessed by the Six Minute Walk Test (6MWT)
Time frame: 6 months
Distance Walked as Assessed by the Six Minute Walk Test (6MWT)
Time frame: 12 months
Number of Clinical Relapses
Time frame: 12 months
New Activity on MRI (T2 Lesions, Gd+)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pediatric Onset Multiple Sclerosis (POMS)
Recruiting
Dual-Task Training in Pediatric Multiple Sclerosis
Pediatric-Onset Multiple Sclerosis (POMS)
Not yet recruiting
Comparison of Structured Exercise and Exergaming in Pediatric-Onset Multiple Sclerosis
Pediatric-Onset Multiple Sclerosis (POMS), Exercise Training
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Garcia-Tarodo, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR active video game intervention, Educational session and Standard Management of Physical Activity in people with Pediatric Onset Multiple Sclerosis (POMS), run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT) (time frame: 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.