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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03933020
Other study ID # HSC-MS-19-0247
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 10, 2019
Est. completion date May 31, 2019

Study information

Verified date May 2022
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 disability, and motor assessments (6MWT).


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 15 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
Standard Management of Physical Activity
Routine discussion of lifestyle factors including physical activity during clinic visits

Locations

Country Name City State
United States The University of Texas Health Science Center,Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston Microsoft Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 3 months
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. 6 months
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. 12 months
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). 3 months
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). 6 months
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). 12 months
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). 3 months
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). 6 months
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). 12 months
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. 3 Month
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. 6 month
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. 12 month
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. 3 months
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. 6 month
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. 12 month
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. 3 month
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. 6 month
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. 12 month
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 6 months
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 12 months
Secondary Number of Clinical Relapses Assessment at each clinic visit 12 months
Secondary New Activity on MRI (T2 Lesions, Gd+) Assessment at each MRI 12 months
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. 1 month
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. 3 month
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. 6 month
Secondary Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire 6 months
Secondary Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire 12 months