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

NCT07257900 | Not Yet Recruiting

• 1 other identifier: IUC-POMS-EXERGAME-2025
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pediatric-Onset Multiple Sclerosis (POMS); Exercise Training

Keywords

Pediatric-onset multiple sclerosis; Physiotherapy; Exergaming; Exercises; telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Timed Up and Go (TUG)

  Time to rise from a chair, walk 3 m, turn, return, and sit. Shorter times indicate better mobility. It is an objective test used to assess functional mobility and balance in people with MS. Before the assessment, the patient is shown how the test will be performed. The patient is then asked to get up from a chair, walk 3 meters at a comfortable pace, and return to the chair and sit down. The test is repeated three times. The time taken in each attempt is recorded in seconds using a stopwatch.

  Baseline and at 8 weeks

Secondary Outcomes (8)

• Mini-BESTest

  Baseline and at 8 weeks

• 6 Minute Walk Test (6MWT)

  Baseline and at 8 weeks

• Five Times Sit-to-Stand (5xSTS)

  Baseline and at 8 weeks

• Pedometer (Omron HJ-321-E)

  Baseline and at 8 weeks

• Godin Leisure-Time Exercise Questionnaire (GLTEQ)

  Baseline and at 8 weeks

Study Arms (2)

Structured Functional Exercise Training

EXPERIMENTAL

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.

Behavioral: Structured Functional Exercise Program

Exergaming-Based Rehabilitation

EXPERIMENTAL

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.

Behavioral: Exergaming Rehabilitation

Interventions

Structured Functional Exercise Program 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

Structured Functional Exercise Training

Exergaming Rehabilitation 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.

Exergaming-Based Rehabilitation

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Related Publications (13)

• Sebastiao E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Jul;97(7):1072-7. doi: 10.1016/j.apmr.2015.12.031. Epub 2016 Mar 2.

  PMID: 26944709 BACKGROUND

• Boiko A, Vorobeychik G, Paty D, Devonshire V, Sadovnick D; University of British Columbia MS Clinic Neurologists. Early onset multiple sclerosis: a longitudinal study. Neurology. 2002 Oct 8;59(7):1006-10. doi: 10.1212/wnl.59.7.1006.

  PMID: 12370453 BACKGROUND

• Grover SA, Sawicki CP, Kinnett-Hopkins D, Finlayson M, Schneiderman JE, Banwell B, Till C, Motl RW, Yeh EA. Physical Activity and Its Correlates in Youth with Multiple Sclerosis. J Pediatr. 2016 Dec;179:197-203.e2. doi: 10.1016/j.jpeds.2016.08.104. Epub 2016 Oct 4.

  PMID: 27717498 BACKGROUND

• Weikert M, Motl RW, Suh Y, McAuley E, Wynn D. Accelerometry in persons with multiple sclerosis: measurement of physical activity or walking mobility? J Neurol Sci. 2010 Mar 15;290(1-2):6-11. doi: 10.1016/j.jns.2009.12.021. Epub 2010 Jan 8.

  PMID: 20060544 BACKGROUND

• Yeh EA, Kinnett-Hopkins D, Grover SA, Motl RW. Physical activity and pediatric multiple sclerosis: Developing a research agenda. Mult Scler. 2015 Nov;21(13):1618-25. doi: 10.1177/1352458515606526. Epub 2015 Oct 7.

  PMID: 26447061 BACKGROUND

• Moller AB, Bibby BM, Skjerbaek AG, Jensen E, Sorensen H, Stenager E, Dalgas U. Validity and variability of the 5-repetition sit-to-stand test in patients with multiple sclerosis. Disabil Rehabil. 2012;34(26):2251-8. doi: 10.3109/09638288.2012.683479. Epub 2012 May 22.

  PMID: 22612360 BACKGROUND

• Chan WLS, Chan CWL, Chan HHW, Chan KCK, Chan JSK, Chan OLW. A randomised controlled pilot study of a Nintendo Ring Fit Adventure balance and strengthening exercise program in community-dwelling older adults with a history of falls. Australas J Ageing. 2024 Sep;43(3):533-544. doi: 10.1111/ajag.13297. Epub 2024 Feb 26.

  PMID: 38404233 BACKGROUND

• Alba-Rueda A, Lucena-Anton D, De Miguel-Rubio A. Effectiveness of two different exergaming systems in addition to conventional treatment for physical therapy in patients with multiple sclerosis: A study protocol for a multicenter, assessor-blind, 24-week, randomized controlled trial. Digit Health. 2024 Oct 18;10:20552076241287874. doi: 10.1177/20552076241287874. eCollection 2024 Jan-Dec.

  PMID: 39430704 BACKGROUND

• Grover SA, Aubert-Broche B, Fetco D, Collins DL, Arnold DL, Finlayson M, Banwell BL, Motl RW, Yeh EA. Lower physical activity is associated with higher disease burden in pediatric multiple sclerosis. Neurology. 2015 Nov 10;85(19):1663-9. doi: 10.1212/WNL.0000000000001939. Epub 2015 Aug 12.

  PMID: 26268901 BACKGROUND

• Polizzi A, Rinella S, Ruggieri M, Gentile AE, Verrelli CM, Iosa M. Efficacy of videogames and exergames in pediatric neurorehabilitation: a systematic review. Minerva Pediatr (Torino). 2024 Oct;76(5):690-702. doi: 10.23736/S2724-5276.23.07146-X. Epub 2023 Jun 16.

  PMID: 37335184 BACKGROUND

• Sikes EM, Richardson EV, Motl RW. A Qualitative Study of Exercise and Physical Activity in Adolescents with Pediatric-Onset Multiple Sclerosis. Int J MS Care. 2019 Mar-Apr;21(2):81-91. doi: 10.7224/1537-2073.2018-033.

  PMID: 31049039 BACKGROUND

• Yazgan YZ, Tarakci E, Tarakci D, Ozdincler AR, Kurtuncu M. Comparison of the effects of two different exergaming systems on balance, functionality, fatigue, and quality of life in people with multiple sclerosis: A randomized controlled trial. Mult Scler Relat Disord. 2020 Apr;39:101902. doi: 10.1016/j.msard.2019.101902. Epub 2019 Dec 21.

  PMID: 31924591 BACKGROUND

• Vural P, Zenginler Yazgan Y, Tarakci E, Guler S, Saltik S. The effects of online exercise training on physical functions and quality of life in patients with pediatric-onset multiple sclerosis. Mult Scler Relat Disord. 2023 Jun;74:104710. doi: 10.1016/j.msard.2023.104710. Epub 2023 Apr 9.

  PMID: 37086635 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Serhat Güler, Assoc. Prof.

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

  STUDY CHAIR

• Sema Saltık, Prof. Dr.

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

  STUDY CHAIR

Central Study Contacts

Yonca Zenginler Yazgan, PhD, PT

CONTACT

+905326006294; yoncazenginler@gmail.com

Melisa Topaloglu, MSc

CONTACT

+905070749119; topaloglu.melisa95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share