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

NCT ID: NCT03933020

Last Updated: 2022-05-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2019-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Onset Multiple Sclerosis (POMS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise Group

Group Type EXPERIMENTAL

VR active video game intervention

Intervention Type DEVICE

The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise

Educational session

Intervention Type BEHAVIORAL

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.

Control Group

Group Type ACTIVE_COMPARATOR

Standard Management of Physical Activity

Intervention Type BEHAVIORAL

Routine discussion of lifestyle factors including physical activity during clinic visits

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Standard Management of Physical Activity

Routine discussion of lifestyle factors including physical activity during clinic visits

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Microsoft Corporation

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rohini Samudralwar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephanie Garcia-Tarodo, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Texas Health Science Center,Houston

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC-MS-19-0247

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.