Dual-Task Training in Pediatric Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dual-Task Exercise Training
BehavioralThis 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
Conventional Functional Exercise Training
BehavioralThis 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.
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Dual-Task Exercise TrainingExperimental treatment 1 intervention
Group B: Conventional Functional Exercise TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery
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.
Time frame
Baseline and at 8 weeks2
6-Minute Walk Test
Distance covered during the 6-Minute Walk Test (6MWT). This test measures functional exercise capacity and walking endurance. Higher distance indicates better motor performance.
Time frame
Baseline and at 8 weeksSecondary outcomes
1
Mini-BESTest
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).
Time frame
Baseline and at 8 weeks2
Timed Up and Go Test (TUG)
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.
Time frame
Baseline and at 8 weeks3
PedsQL Multidimensional Fatigue Scale
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).
Time frame
Baseline and at 8 weeks4
Pediatric Quality of Life Inventory (PedsQL)
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).
Time frame
Baseline and at 8 weeksSponsors and contacts
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Source ClinicalTrials.gov