Comparison of Structured Exercise and Exergaming in Pediatric-Onset Multiple Sclerosis

NCT07257900 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-02

No results posted yet for this study

Summary

This study will examine how two different exercise programs affect children and young adults with pediatric-onset multiple sclerosis (POMS). POMS is a type of multiple sclerosis that begins in childhood or adolescence and can cause fatigue, weakness, balance problems, and difficulty moving. This study aims to evaluate the effectiveness of a video game-based exercise program (exergaming) compared with traditional exercise training in enhancing balance, physical activity levels, reducing fatigue, and improving quality of life in individuals with pediatric-onset multiple sclerosis. Approximately 30 participants aged 12 to 22 years old who have been diagnosed with POMS and have mild to moderate symptoms (Extended Disability Status Scale \[EDSS\] score below 6) will participate in the study.

Participants will be randomly assigned to one of two groups:

Traditional Exercise Group: Participants will receive structured exercise instruction via live Zoom sessions (a tele-rehabilitation model). For 8 weeks, twice a week, they will perform supervised aerobic, strength, and balance exercises, each lasting approximately 45 minutes.

Exercise Game Group: Participants will perform similar aerobic, strength training, and balance exercises using the Nintendo Switch Ring Fit Adventure™ video game system.

Researchers will evaluate participants' physical activity levels, balance, fatigue, and quality of life parameters at baseline and after completing the 8-week intervention.

The study aims to determine whether the exergaming program can help participants increase their physical activity, reduce fatigue, and improve balance and daily functioning compared with traditional exercise. This approach offers an engaging and technology-supported way to incorporate physical activity into the rehabilitation of young people with POMS.

Conditions

  • Pediatric-Onset Multiple Sclerosis (POMS)
  • Exercise Training

Interventions

BEHAVIORAL

Structured Functional Exercise Program

Sessions will be conducted twice per week for 8 weeks via live online video conferencing (Zoom) under the supervision of a physiotherapist. Each session will last 45-60 minutes and include aerobic, strengthening, and balance exercises adapted for home environments. At the beginning of the program, there will be approximately 5 minutes of low-to-moderate intensity warm-up exercises, followed by approximately 20 minutes of aerobic exercises, approximately 20 minutes of strength and balance exercises, and 5 minutes of cool-down exercises. These exercises are structured with increasing intensity over the weeks. * Weeks 1-2: 2 sets x 10 reps * Weeks 3-4: 2 sets x 15 reps * Weeks 5-6: 2 sets x 10 reps, with half a kilo added for the upper extremities and one kilo added for the lower extremities. * Weeks 7-8: 2 sets x 15 reps with free weights

BEHAVIORAL

Exergaming Rehabilitation

The intervention will use interactive motion-based video games, such as the Nintendo Switch Ring Fit Adventure™ platform, incorporating aerobic, strengthening, and balance activities. Each session will provide visual and auditory feedback to promote motivation and adherence. Sessions will be conducted twice per week for 8 weeks under physiotherapist supervision.It will be implemented at three levels: beginner, intermediate, and advanced. The number of repetitions and difficulty levels will be gradually increased. The first two weeks will be at the beginner level, weeks 3-5 at the intermediate level, and weeks 6-8 at the advanced level. The session will begin with a 5-minute warm-up, followed by approximately 20 minutes of aerobic exercises, approximately 20 minutes of strength and balance exercises, and conclude with a 5-minute cool-down. The program's exergame training activities include jogging, mini games, strength training, balance, and yoga exercises.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Serhat Güler, Assoc. Prof. · Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Department of Pediatric Neurology

  • Sema Saltık, Prof. Dr. · Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07257900 on ClinicalTrials.gov