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

The University of Texas System (UT)

Status: Terminated

Conditions: Pediatric Onset Multiple Sclerosis (POMS)

Treatments: Device: VR active video game intervention; Behavioral: Educational session; Behavioral: Standard Management of Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT03933020

HSC-MS-19-0247

Details and patient eligibility

About

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).

Enrollment: 2 patients

Sex: All

Ages: 15 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Exercise Group

Experimental group

Treatment:

Behavioral: Educational session

Device: VR active video game intervention

Control Group

Active Comparator group

Treatment:

Behavioral: Standard Management of Physical Activity