Pediatric-Onset Multiple Sclerosis (POMS)NCT07257900
Comparison of Structured Exercise and Exergaming in Pediatric-Onset Multiple Sclerosis
A study testing Structured Functional Exercise Program and Exergaming Rehabilitation in people with Pediatric-Onset Multiple Sclerosis (POMS) and Exercise Training, run by Istanbul University - Cerrahpasa.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Pediatric-Onset Multiple Sclerosis (POMS), Exercise Training
- What is being tested?
- Structured Functional Exercise Program and Exergaming Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Video Game-Based Exercise Training on Physical Activity, Balance, Fatigue, and Quality of Life in Pediatric-Onset Multiple Sclerosis Patients
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:
Read more
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.
Read the 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.
- Being tested
- Structured Functional Exercise Program, Exergaming Rehabilitation
- Keywords
- Pediatric-onset multiple sclerosis, Physiotherapy, Exergaming, Exercises, telerehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Functional Exercise ProgramBehavioural
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 RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exergaming Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 8 weeks
Secondary outcomes (8)
Mini-BESTest
The Mini-BESTest consists of 14 items or activities grouped into 4 sections: expected postural control (sitting to standing, toe-standing, standing on one leg), reactive postural control (compensatory stepping forward, backward, and sideways), sensory orientation (standing with eyes open on a firm surface, standing with eyes closed on a foam surface, standing with eyes closed on an inclined ramp), and dynamic gait (changing walking speed, walking with head turns, walking with pivot turns, stepping over an obstacle, timed stand and go with a dual task). The quality of performance on an item is represented by specific item scores (normal = 2, moderate = 1, and severe = 0) that add up to a total score ranging from 0 to 28. The expected postural control, reactive postural control, and sensory orientation section scores each range from 0 to 6, while the dynamic walking section score ranges from 0 to 10. Higher total and section scores indicate better balance control.
Measured: Baseline and at 8 weeks
6 Minute Walk Test (6MWT)
It is a simple, practical test applied according to the standard protocol of the American Thoracic Society to measure walking capacity. It has been reported that the test is valid and reliable in MS patients with mild and moderate disability. In our study, 6 MWTs will be performed in accordance with the standards set in the guidelines for MS patients. The participant will be asked to walk as fast as possible at his own walking pace on the 30-meter track for 6 minutes. Before starting the test, participants will be explained that they can rest if they develop excessive fatigue or respiratory distress during the test and that this time is included in the test period. As a result of the test, the distance traveled by the participant will be recorded in meters.
Measured: Baseline and at 8 weeks
Five Times Sit-to-Stand (5xSTS)
The arms are placed crosswise at chest level, and the patient is asked to sit down and stand up 5 times as quickly as possible from a standard chair. The test begins in a sitting position and ends in a sitting position. The result is recorded in seconds. This method, which is valid and reliable in MS, has been shown to be related to lower extremity muscle strength and balance. Lower times indicate higher performance. It is reliable in assessing lower extremity function.
Measured: Baseline and at 8 weeks
Pedometer (Omron HJ-321-E)
It is an objective device used to assess physical activity levels and record the number of steps taken. Participants in the study will be provided with the Omron HJ-321-E brand pedometer, which is lightweight and easy to carry. All pedometers are calibrated with personalized measurements (step length, weight, height). Patients are asked to attach the pedometer to their non-dominant leg, either on a belt or clothing. The number of steps taken by participants over the course of one week will be recorded.
Measured: Baseline and at 8 weeks
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
This two-question survey measures individuals' physical activity behavior. The GBZEA is a simple, valid, and effective primary outcome measure for defining activity levels and tracking changes after an intervention. The first question asks how often light, moderate, and vigorous activities lasting over 15 minutes are performed in a typical week. The second asks how often activities causing sweating occur. To calculate the score, weekly frequencies are multiplied by 3, 5, and 9 metabolic equivalents (METs) for light, moderate, and vigorous activity, respectively. The moderate + vigorous score is obtained by adding moderate and vigorous points, while the total score is the sum of light, moderate, and vigorous activity points.
Measured: Baseline and at 8 weeks
Multiple Sclerosis Functional Composite (MSFC)
It provides a more quantitative assessment than the EDSS. The Timed 25-Foot Walk (T25W) evaluates lower limb function by measuring the time needed to walk 8 meters (25 feet); it is repeated twice and averaged. The Nine Hole Peg Test (NHPT) measures upper limb function by timing how fast pegs are placed into nine holes; it is repeated twice for each hand and averaged. Cognitive function is assessed with the 3-second Paced Auditory Serial Addition Test (PASAT-3), where patients add each new number they hear to the previous one during a 3-minute test with 60 responses. The MSFC score combines results from all three tests into a single composite score using calculated z-scores.
Measured: Baseline and at 8 weeks
Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL-MFS)
PedsQL-MFS total score (0-100 transformed).This scale is a valid and reliable measure for assessing fatigue levels in the pediatric population. It consists of two separate forms: self-report and proxy report. The versions for the 13-18 and 18-25 age groups will be used in this study. The 18-item symptom-focused scale assesses three areas of fatigue (general, sleep/rest, and cognitive). Items are reverse-scored, rated, and converted linearly to a 0-100 scale: 0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0. Higher scores indicate higher levels of fatigue. Higher scores represent less fatigue.
Measured: Baseline and at 8 weeks
Pediatric Quality of Life Inventory (PedsQL)
It includes two parallel forms for children and families to complete and consists of sections on physical functions (8 items), emotional functions (5 items), social functions (5 items), and school functions (5 items). The child form has been developed for the 5-7, 8-12, 13-18, and 18-25 age groups, while the family form has been developed for the 2-4, 5-7, 8-12, 13-18, and 18-25 age groups. The inventory, prepared according to a five-point Likert scale, indicates that 0 = never caused a problem, 1 = hardly ever caused a problem, 2 = sometimes caused a problem, 3 = often caused a problem, and 4 = always caused a problem. A linear conversion is applied in calculating the total score of the scale, and the evaluation is made on a scale of 0-100 points (0=100, 1=75, 2=50, 3=25, 4=0). A high PedsQL score indicates better health-related quality of life. In our study, both the child and parent versions of the PedsQL will be used.
Measured: Baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pediatric-Onset Multiple Sclerosis (POMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melisa Topaloglu, Istanbul University - Cerrahpasa
- Investigators
- Serhat Güler, Assoc. Prof., Study chair, Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Department of Pediatric NeurologySema Saltık, Prof. Dr., Study chair, Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257900
- Sponsor's protocol ID
- IUC-POMS-EXERGAME-2025
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (including age, sex, and outcome measures) may be shared upon reasonable request, following approval by the ethics committee and the supervising institution.
Publications
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.
PubMed 26944709Boiko 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.
PubMed 12370453Grover 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.
PubMed 27717498Weikert 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.
PubMed 20060544Yeh 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.
PubMed 26447061Moller 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.
PubMed 22612360Chan 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.
PubMed 38404233Alba-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.
PubMed 39430704Grover 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.
PubMed 26268901Polizzi 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.
PubMed 37335184Sikes 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.
PubMed 31049039Yazgan 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.
PubMed 31924591Vural 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.
PubMed 37086635
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Video Game-Based Exercise Training on Physical Activity, Balance, Fatigue, and Quality of Life in Pediatric-Onset Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT07257900
- Acronym / sponsor ID
- IUC-POMS-EXERGAME-2025
- Keywords
- Pediatric-onset multiple sclerosis, Physiotherapy, Exergaming, Exercises, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Functional Exercise Training | Experimental | Behavioral: Structured Functional Exercise ProgramParticipants 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. |
| Exergaming-Based Rehabilitation | Experimental | Behavioral: Exergaming RehabilitationParticipants 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. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Functional Exercise ProgramSessions 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 | Behavioural | Structured Functional Exercise Training |
| Exergaming RehabilitationThe 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. | Behavioural | Exergaming-Based Rehabilitation |
Primary outcome
Timed Up and Go (TUG)
Time frame: Baseline and at 8 weeks
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.
8 secondary outcomes
Mini-BESTest
Time frame: Baseline and at 8 weeks
6 Minute Walk Test (6MWT)
Time frame: Baseline and at 8 weeks
Five Times Sit-to-Stand (5xSTS)
Time frame: Baseline and at 8 weeks
Pedometer (Omron HJ-321-E)
Time frame: Baseline and at 8 weeks
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Baseline and at 8 weeks
Multiple Sclerosis Functional Composite (MSFC)
Time frame: Baseline and at 8 weeks
Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL-MFS)
Time frame: Baseline and at 8 weeks
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline and at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 26944709Sebastiao 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.
- Background: PubMed 12370453Boiko 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.
- Background: PubMed 27717498Grover 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.
- Background: PubMed 20060544Weikert 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.
- Background: PubMed 26447061Yeh 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.
- Background: PubMed 22612360Moller 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.
- Background: PubMed 38404233Chan 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.
- Background: PubMed 39430704Alba-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.
- Background: PubMed 26268901Grover 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.
- Background: PubMed 37335184Polizzi 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.
- Background: PubMed 31049039Sikes 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.
- Background: PubMed 31924591Yazgan 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.
- Individual participant dataSharing planned: No. De-identified individual participant data (including age, sex, and outcome measures) may be shared upon reasonable request, following approval by the ethics committee and the supervising institution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Serhat Güler, Assoc. Prof. study chair
Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Department of Pediatric Neurology
Sema Saltık, Prof. Dr. study chair
Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine, Department of Pediatric Neurology
Questions about this trial
What is this clinical trial studying?
A study testing Structured Functional Exercise Program and Exergaming Rehabilitation in people with Pediatric-Onset Multiple Sclerosis (POMS) and Exercise Training, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yonca Zenginler Yazgan, PhD, PT (+905326006294, yoncazenginler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: Baseline and at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07257900, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.