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

Not Applicable

Terminated

• Conditions: Pediatric Onset Multiple Sclerosis (POMS)
• Interventions: Device: VR active video game intervention; Behavioral: Standard Management of Physical Activity; Behavioral: Educational session

• Registration Number: NCT03933020
• Lead Sponsor: The University of Texas Health Science Center, Houston

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 available

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-05-01
• Study Start: 2019-05-10
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Disposition First Submitted: 2021-04-12
• Results First Submitted: 2022-01-13
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-17
• Disposition First Submitted QC: 2022-05-17
• Last Update Submitted: 2022-05-17
• Results First Posted: 2022-05-19
• Disposition First Posted: 2022-05-19
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Educational session	-
Exercise Group	VR active video game intervention	-
Control Group	Standard Management of Physical Activity	-

Primary Outcome Measures

Name	Time	Method
Cognitive Disability as Assessed by the Brief International Cognitive Assessment for MS (BICAMS) - Symbol Digit Modalities Test (SDMT)	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)	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	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

Name	Time	Method
Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)	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.
New Activity on MRI (T2 Lesions, Gd+)	12 months	Assessment at each MRI
Degree of Incorporation of Physical Activity Into Daily Life as Assessed by a Self Report Questionnaire	12 months
Physical and Psychological Impact of MS as Assessed by the Multiple Sclerosis Impact Scale-29 (MSIS-29)	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.
Distance Walked as Assessed by the Six Minute Walk Test (6MWT)	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	12 months	Assessment at each clinic visit
Fatigue as Assessed by the Modified Fatigue Impact Scale (MFIS)	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.
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

Trial Locations

Locations (1)

The University of Texas Health Science Center,Houston; 🇺🇸 Houston, Texas, United States