Pediatric-Onset Multiple Sclerosis (POMS)
Conditions
Keywords
Pediatric-Onset Multiple Sclerosis, Dual Task, Dual Task Exercise
Brief summary
This randomized controlled trial aims to investigate the effects of an 8-week dual-task exercise training program compared to conventional functional exercise training on motor and cognitive functions in adolescents with pediatric-onset multiple sclerosis (PBMS). PBMS is a rare, chronic demyelinating disease of the central nervous system that begins in childhood or adolescence and often leads to motor impairments, balance problems, fatigue, and cognitive deficits, particularly in information processing speed, attention, memory, and executive functions. These symptoms significantly affect independence in daily activities and quality of life. Participants aged 12-18 years with PBMS diagnosis (according to the 2017 revised McDonald criteria) and Expanded Disability Status Scale (EDSS) score below 6 will be randomly assigned to two parallel groups. Both groups will receive 16 supervised sessions (twice a week for 8 weeks, approximately 45 minutes per session). The conventional exercise group will perform structured functional exercises including aerobic stepping, progressive strengthening, and balance training. The dual-task group will perform the same motor exercises while simultaneously completing cognitive tasks (such as backward counting, color and object matching, simple mathematical operations, alphabet-based word finding, and short story telling). Cognitive task difficulty will be progressively increased weekly. Outcomes will be assessed at baseline and immediately after the 8-week intervention. Primary outcomes include motor function (6-Minute Walk Test), functional mobility (Timed Up and Go Test), balance (Mini-BESTest), and cognitive performance (Brief International Cognitive Assessment for Multiple Sclerosis - BICAMS battery). Secondary outcomes include fatigue (PedsQL Multidimensional Fatigue Scale), health-related quality of life (PedsQL Generic Core Scales - child and parent versions), and Multiple Sclerosis Functional Composite (MSFC). We hypothesize that the dual-task exercise program will produce superior improvements in motor functions, balance, cognitive performance, fatigue, and quality of life compared to conventional exercise training.
Detailed description
Pediatric-onset multiple sclerosis (PBMS) is a chronic inflammatory demyelinating disorder of the central nervous system that begins in childhood or adolescence. It can cause significant long-term motor deficits, balance problems, fatigue, and cognitive impairments that negatively affect school performance, social participation, and overall quality of life (Ghezzi et al., 2017; McKay et al., 2019). Traditional rehabilitation approaches in PBMS often address motor and cognitive domains separately, whereas most daily life activities require the simultaneous integration of motor and cognitive skills. Dual-task training, which involves performing motor and cognitive tasks concurrently, has been shown to improve the interaction between these systems, enhance neuroplasticity, and lead to better functional outcomes in adult multiple sclerosis populations (Abasıyanık & Kahraman, 2022; Ekici et al., 2025; Beste et al., 2018). However, evidence regarding the effectiveness of dual-task training specifically in pediatric-onset multiple sclerosis remains limited. This single-center, randomized controlled trial aims to fill this gap by comparing the effectiveness of a structured dual-task exercise program versus a dose-matched conventional functional exercise program in adolescents with PBMS. Study Design and Intervention A total of 20 participants (10 per group) will be recruited. After baseline assessment, participants will be randomly allocated to one of two groups: Dual-Task Exercise Group: Participants will perform aerobic, strengthening, and balance exercises while simultaneously engaging in cognitive tasks. Cognitive tasks include backward counting, color/object matching, mental arithmetic, alphabet-based word finding, and short storytelling. Task difficulty will be progressively increased over the 8 weeks. Conventional Functional Exercise Group: Participants will receive a traditional physiotherapy program consisting of warm-up, aerobic stepping exercises, progressive strengthening (bridge, squats, lunges, etc.), balance training (tandem stance, single-leg stance), and cool-down exercises without concurrent cognitive loading. Both interventions will last 8 weeks, with sessions held twice weekly for approximately 45 minutes each (5 min warm-up, 35 min main exercises, 5 min cool-down). All sessions will be supervised by a physiotherapist at Istanbul University-Cerrahpaşa Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Outcome Measures Assessments will be conducted before and after the intervention period using the following validated tools: Motor function and walking endurance: 6-Minute Walk Test (6MWT) Functional mobility: Timed Up and Go Test (TUG) Balance: Mini-BESTest Cognitive functions: Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery Fatigue: PedsQL Multidimensional Fatigue Scale (MFS) Health-related quality of life: Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales (child and parent forms) Multiple Sclerosis Functional Composite (MSFC) This study is expected to provide important evidence on whether incorporating dual-task training into pediatric MS rehabilitation yields greater benefits on motor, cognitive, and functional outcomes compared to conventional exercise. The findings may contribute to the development of more effective, motivating, and holistic rehabilitation strategies for children and adolescents with PBMS.
Interventions
BEHAVIORALConventional Functional Exercise Training
This control intervention consists of a structured, progressive conventional physiotherapy program matched in duration, frequency, and total exercise dose to the dual-task group. The program includes: Warm-up (5 min): Low-intensity walking and upper extremity mobility exercises. Aerobic exercises (20-25 min): Progressive stepping exercises in multiple directions, coordination movements, and light aerobic activities. Strengthening and balance exercises: Progressive resistance training targeting lower extremity and core muscles (bridge, squats, lunges, single-leg support, tandem stance) and dynamic balance activities. Exercise intensity and volume are increased weekly based on individual capacity. Cool-down (5 min): Stretching and breathing exercises. No concurrent cognitive tasks are added to the motor exercises in this group. This arm serves as an active comparator to evaluate the additional benefit of the dual-task component.
BEHAVIORALDual-Task Exercise Training
This intervention involves the simultaneous performance of motor and cognitive tasks during structured physiotherapy sessions. The motor component includes: Warm-up (5 min): Low-intensity walking and upper extremity range of motion exercises. Aerobic exercises (20-25 min): Multi-directional stepping, forward-backward and cross stepping, side stepping, and light jogging patterns to improve cardiovascular endurance and coordination. Strengthening and balance exercises (progressive): Bridge exercise, squats, lunges, single-leg stance, tandem stance, core stabilization, and hip strengthening exercises. Difficulty is increased gradually by adding repetitions, sets, or resistance (e.g., free weights) over the 8 weeks. Cognitive tasks (performed simultaneously with motor exercises): Backward counting by 3s or 7s, color and object matching, simple arithmetic operations, alphabet-based word generation, and short story telling. Cognitive task complexity is progressively increased each week. Coo
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of pediatric-onset multiple sclerosis according to the 2017 revised McDonald criteria Age between 12 and 18 years Expanded Disability Status Scale (EDSS) score \< 6
Exclusion criteria
* Additional orthopedic problem affecting mobility Significant blurred vision affecting vision Any other neurological or systemic disease besides PBMS Relapse or corticosteroid treatment within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery | Baseline and at 8 weeks | Scores obtained from the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which includes three tests: Symbol Digit Modalities Test (SDMT) for information processing speed and attention, California Verbal Learning Test-II (CVLT-II) for verbal learning and memory, and Brief Visuospatial Memory Test-Revised (BVMT-R) for visuospatial learning and memory. Higher scores indicate better cognitive function. |
| 6-Minute Walk Test | Baseline and at 8 weeks | Distance covered during the 6-Minute Walk Test (6MWT). This test measures functional exercise capacity and walking endurance. Higher distance indicates better motor performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini-BESTest | Baseline and at 8 weeks | Total score and subsection scores of the Mini-BESTest (Mini Balance Evaluation Systems Test). This 14-item scale assesses anticipatory postural control, reactive postural control, sensory orientation, and dynamic gait. Higher scores indicate better balance control (maximum score: 28). |
| Timed Up and Go Test (TUG) | Baseline and at 8 weeks | Time taken to complete the Timed Up and Go Test (TUG). Participants rise from a chair, walk 3 meters, turn, walk back, and sit down. Shorter time indicates better functional mobility and dynamic balance. |
| PedsQL Multidimensional Fatigue Scale | Baseline and at 8 weeks | Scores from the PedsQL Multidimensional Fatigue Scale (PedsQL MFS). This 18-item scale evaluates general fatigue, sleep/rest fatigue, and cognitive fatigue from both child self-report and parent proxy-report perspectives. Higher scores indicate lower fatigue levels (0-100 scale). |
| Pediatric Quality of Life Inventory (PedsQL) | Baseline and at 8 weeks | Scores from the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales (4.0). This scale includes physical, emotional, social, and school functioning domains, completed by both the child/adolescent and one parent. Higher scores reflect better health-related quality of life (0-100 scale). |
| Multiple Sclerosis Functional Composite (MSFC) | Baseline and at 8 weeks | Overall score of the Multiple Sclerosis Functional Composite (MSFC), which combines three components: Timed 25-Foot Walk Test (T25FW) for lower extremity function, Nine-Hole Peg Test (NHPT) for upper extremity function, and Paced Auditory Serial Addition Test (PASAT-3") for cognitive function. Z-scores are calculated and averaged. Higher composite score indicates better overall neurological function. |
Countries
Turkey (Türkiye)
Contacts
CONTACTYonca Zenginler Yazgan
CONTACTAyten Alihuseynli
Outcome results
None listed