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Dual-Task Training in Pediatric Multiple Sclerosis (DTT-POMS)

2026. április 29. frissítette: Ayten Alihuseynli, Istanbul University - Cerrahpasa

The Effect of Dual-Task Training on Motor and Cognitive Functions in Pediatric-Onset Multiple Sclerosis Patients

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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

22

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

  • Törökország (Türkiye)
      • Istanbul, Törökország (Türkiye), 34000
        • Toborzás
        • Istanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Aytan Alihuseynli

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Gyermek
  • Felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Dual-Task Exercise Training

Participants in this group will receive an 8-week structured dual-task exercise program. The intervention consists of 16 supervised sessions (2 sessions per week, approximately 45 minutes per session). Each session includes three phases: a 5-minute warm-up, 35 minutes of main exercises, and a 5-minute cool-down.

The program combines motor exercises (aerobic, strengthening, and balance training) with simultaneous cognitive tasks targeting attention, working memory, and executive functions. Motor exercises include progressive aerobic stepping patterns, strengthening exercises (bridge, squats, lunges, single-leg stance), and balance exercises (tandem stance, single-leg balance, weight shifting). Cognitive tasks performed concurrently with motor exercises include backward counting, color and object matching, simple mathematical operations, alphabet-based word finding, and short story telling. The difficulty level of both motor and cognitive components will be progressively increased weekl
Viselkedési: Dual-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
Kísérleti: Conventional Functional Exercise Training

Participants in this group will receive a dose-matched 8-week conventional functional exercise program consisting of 16 supervised sessions (2 sessions per week, approximately 45 minutes per session). Each session follows the same structure: a 5-minute warm-up, 35 minutes of main exercises, and a 5-minute cool-down.

The program includes progressive aerobic exercises (multi-directional stepping, light jogging patterns), strengthening exercises (bridge, squats, lunges, hip strengthening, core stabilization), and balance training (tandem stance, single-leg stance, dynamic balance activities). Unlike the experimental group, motor exercises are performed without any concurrent cognitive tasks. The intensity and progression of exercises will be individually adjusted weekly based on participant tolerance, similar to the dual-task group, to ensure equal training dose between groups.
Viselkedési: Conventional 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery
Időkeret: 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.
Baseline and at 8 weeks
6-Minute Walk Test
Időkeret: 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.
Baseline and at 8 weeks

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Mini-BESTest
Időkeret: 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).
Baseline and at 8 weeks
Timed Up and Go Test (TUG)
Időkeret: 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.
Baseline and at 8 weeks
PedsQL Multidimensional Fatigue Scale
Időkeret: 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).
Baseline and at 8 weeks
Pediatric Quality of Life Inventory (PedsQL)
Időkeret: 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).
Baseline and at 8 weeks
Multiple Sclerosis Functional Composite (MSFC)
Időkeret: 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.
Baseline and at 8 weeks

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Istanbul University - Cerrahpasa

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. április 1.

Elsődleges befejezés (Becsült)

2026. december 1.

A tanulmány befejezése (Becsült)

2027. április 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. április 29.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. április 29.

Első közzététel (Tényleges)

2026. május 6.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. május 6.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. április 29.

Utolsó ellenőrzés

2026. április 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

Egyéb vizsgálati azonosító számok

  • 2026/38

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

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