Actively Recruiting

Phase Not Applicable
Age: 12Years - 18Years
All Genders
NCT07571304

Dual-Task Training in Pediatric Multiple Sclerosis

Led by Istanbul University - Cerrahpasa · Updated on 2026-05-06

22

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Dual-Task Training in Pediatric Multiple Sclerosis

Who Can Participate

Age: 12Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Istanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey

Istanbul, Turkey (Türkiye), 34000

Actively Recruiting

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Research Team

Y

Yonca Zenginler Yazgan

CONTACT

A

Ayten Alihuseynli

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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