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

NCT ID: NCT07257900

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

Pediatric-onset multiple sclerosis (POMS) is a chronic demyelinating disorder of the central nervous system that begins in childhood or adolescence. It causes lifelong physical and cognitive limitations. Individuals with POMS often experience decreased motor abilities, balance impairments, and fatigue. These symptoms can lower quality of life (Chitnis et al., 2009; Prajjwal et al., 2023). Regular exercise plays a vital role in preserving and improving physical capacity in individuals with multiple sclerosis. However, maintaining adherence to exercise programs among children and adolescents remains a major challenge. Studies have shown that pediatric MS patients often find traditional physiotherapy programs monotonous and may avoid exercise due to fatigue or fear of relapse (Sikes et al., 2019). Exergaming, defined as video game-based physical activity, has emerged as a promising rehabilitation tool. It combines physical exercise with motivational and interactive game elements. By providing real-time feedback, sensory engagement, and enjoyment, exergaming may increase adherence and participation in rehabilitation programs. Previous research has reported positive effects of exergaming on balance, fatigue, and quality of life in various neurological populations (Motl & Pilutti, 2016; Polizzi et al., 2024). However, there is limited evidence regarding the effects of exergaming in pediatric-onset multiple sclerosis, especially in Türkiye. This single-center, randomized controlled trial aims to compare the effects of structured functional exercise training and exergaming-based rehabilitation in children and adolescents with POMS. The trial will evaluate physical activity levels, balance, fatigue, and quality of life. A total of 30 participants aged 12-22 years, diagnosed according to the revised 2017 McDonald criteria, and with an Expanded Disability Status Scale (EDSS) score below 6, will be randomly assigned to one of two groups. The conventional physiotherapy group will receive structured exercise training delivered through live Zoom sessions (tele-rehabilitation model). The exergaming group will perform interactive game-based exercises using the Nintendo Switch Ring Fit Adventure™ platform. Both interventions will run for 8 weeks, with sessions twice per week, each lasting 45 minutes, supervised by a physiotherapist. The Structured Functional Exercise Group will perform aerobic, strengthening, coordination, and balance exercises. The Exergaming Group will perform similar exercise components integrated into game scenarios. These scenarios provide visual and auditory feedback and motivation. Outcome assessments will be conducted before and after the intervention period. Assessments will include the following validated instruments: Physical activity level (Godin Leisure-Time Exercise Questionnaire and pedometer step count); Functional mobility (Six-Minute Walk Test and Timed Up and Go Test); Balance (Mini-BESTest Balance Scale); Fatigue (Pediatric Quality of Life Inventory - Multidimensional Fatigue Scale, PedsQL-MFS); Quality of life (Pediatric Quality of Life Inventory, PedsQL 4.0); Functional composite (Multiple Sclerosis Functional Composite, MSFC); and Lower limb strength (Five Times Sit-to-Stand Test). It is hypothesized that the exergaming program will produce improvements in physical activity levels, balance, fatigue perception, and quality of life compared to conventional exercise training. This study aims to provide evidence for the integration of technology-supported rehabilitation approaches into pediatric physiotherapy. It also aims to promote sustainable, motivating, and child-centered exercise models for POMS patients.

Conditions

Pediatric-Onset Multiple Sclerosis (POMS); Exercise Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Structured Functional Exercise Training

Participants in this group will receive a supervised, home-based physiotherapy program delivered via Zoom, including aerobic, strengthening, balance, and coordination exercises. Sessions will take place twice per week for 8 weeks, 45-60 minutes each.

Group Type: EXPERIMENTAL

Structured Functional Exercise Program

Intervention Type: BEHAVIORAL

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

Exergaming-Based Rehabilitation

Participants in this group will perform interactive motion-based games designed to improve physical activity, strength, balance, and motivation. The exergaming sessions will be held twice per week for 8 weeks, each lasting 45-60 minutes, supervised by a physiotherapist.

Group Type: EXPERIMENTAL

Exergaming Rehabilitation

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children and adolescents aged 12-22 years.
• Diagnosed with pediatric-onset multiple sclerosisaccording to the 2017 revised McDonald criteria.
• Expanded Disability Status Scale (EDSS) ≤ 6
• Participate in online exercise sessions via Zoom

Exclusion Criteria

• Presence of orthopedic problems affecting mobility.
• Blurred vision or visual disturbances that could interfere with exergaming or exercise performance.
• Any comorbid medical, neurological, or psychiatric condition that could influence physical performance or study outcomes.
• History of relapse or corticosteroid treatment within the last three months.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Melisa Topaloglu

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serhat Güler, Assoc. Prof.

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Department of Pediatric Neurology

Sema Saltık, Prof. Dr.

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology

Central Contacts

Yonca Zenginler Yazgan, PhD, PT

Role: CONTACT

yoncazenginler@gmail.com

+905326006294

Melisa Topaloglu, MSc

Role: CONTACT

topaloglu.melisa95@gmail.com

+905070749119 ext. +905366797921

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Other Identifiers

IUC-POMS-EXERGAME-2025

Identifier Type: -

Identifier Source: org_study_id