About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Structured Functional Exercise Program
BehavioralSessions 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 Rehabilitation
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
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