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

29 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

22

Fase

  • Non applicabile

Contatti e Sedi

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Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Istanbul, Turchia (Türkiye), 34000
        • Reclutamento
        • Istanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey
        • Contatto:
        • Investigatore principale:
          • Aytan Alihuseynli

Criteri di partecipazione

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Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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

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

Sperimentale: 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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mini-BESTest
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

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Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 aprile 2027

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2026/38

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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