Dual-Task Training in Pediatric Multiple Sclerosis

NCT07571304 | Recruiting

• 1 other identifier: 2026/38
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric-Onset Multiple Sclerosis (POMS)

Keywords

Pediatric-Onset Multiple Sclerosis; Dual Task; Dual Task Exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and at 8 weeks

• 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.

  Baseline and at 8 weeks

Secondary Outcomes (5)

• Mini-BESTest

  Baseline and at 8 weeks

• Timed Up and Go Test (TUG)

  Baseline and at 8 weeks

• PedsQL Multidimensional Fatigue Scale

  Baseline and at 8 weeks

• Pediatric Quality of Life Inventory (PedsQL)

  Baseline and at 8 weeks

• Multiple Sclerosis Functional Composite (MSFC)

  Baseline and at 8 weeks

Study Arms (2)

Dual-Task Exercise Training

EXPERIMENTAL

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

Behavioral: Dual-Task Exercise Training

Conventional Functional Exercise Training

EXPERIMENTAL

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.

Behavioral: Conventional Functional Exercise Training

Interventions

Dual-Task Exercise Training BEHAVIORAL

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

Dual-Task Exercise Training

Conventional Functional Exercise Training BEHAVIORAL

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.

Conventional Functional Exercise Training

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

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

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (13)

• Sikes EM, Richardson EV, Motl RW. A Qualitative Study of Exercise and Physical Activity in Adolescents with Pediatric-Onset Multiple Sclerosis. Int J MS Care. 2019 Mar-Apr;21(2):81-91. doi: 10.7224/1537-2073.2018-033.

  PMID: 31049039 RESULT

• Weikert M, Motl RW, Suh Y, McAuley E, Wynn D. Accelerometry in persons with multiple sclerosis: measurement of physical activity or walking mobility? J Neurol Sci. 2010 Mar 15;290(1-2):6-11. doi: 10.1016/j.jns.2009.12.021. Epub 2010 Jan 8.

  PMID: 20060544 RESULT

• Grover SA, Sawicki CP, Kinnett-Hopkins D, Finlayson M, Schneiderman JE, Banwell B, Till C, Motl RW, Yeh EA. Physical Activity and Its Correlates in Youth with Multiple Sclerosis. J Pediatr. 2016 Dec;179:197-203.e2. doi: 10.1016/j.jpeds.2016.08.104. Epub 2016 Oct 4.

  PMID: 27717498 RESULT

• Sebastiao E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Jul;97(7):1072-7. doi: 10.1016/j.apmr.2015.12.031. Epub 2016 Mar 2.

  PMID: 26944709 RESULT

• Wollesen B, Janssen TI, Muller H, Voelcker-Rehage C. Effects of cognitive-motor dual task training on cognitive and physical performance in healthy children and adolescents: A scoping review. Acta Psychol (Amst). 2022 Apr;224:103498. doi: 10.1016/j.actpsy.2022.103498. Epub 2022 Jan 25.

  PMID: 35091209 RESULT

• Beste C, Muckschel M, Paucke M, Ziemssen T. Dual-Tasking in Multiple Sclerosis - Implications for a Cognitive Screening Instrument. Front Hum Neurosci. 2018 Jan 31;12:24. doi: 10.3389/fnhum.2018.00024. eCollection 2018.

  PMID: 29445335 RESULT

• Ekici PE, Ozkeskin PM, Yuceyar MAN. Effects of dual-task training on balance, gait, dual-task performance, cognitive function, fatigue in individuals with multiple sclerosis: A randomized controlled trial: Dual-Task Training in MS. Mult Scler Relat Disord. 2025 Oct;102:106645. doi: 10.1016/j.msard.2025.106645. Epub 2025 Jul 26.

  PMID: 40737966 RESULT

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 RESULT

• Fischer JS, Rudick RA, Cutter GR, Reingold SC. The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force. Mult Scler. 1999 Aug;5(4):244-50. doi: 10.1177/135245859900500409.

  PMID: 10467383 RESULT

• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.

  PMID: 11468499 RESULT

• Ozakbas S, Yigit P, Cinar BP, Limoncu H, Kahraman T, Kosehasanogullari G. The Turkish validation of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. BMC Neurol. 2017 Dec 6;17(1):208. doi: 10.1186/s12883-017-0993-0.

  PMID: 29207954 RESULT

• Abasiyanik Z, Kahraman T. Effect of dual-task training on cognitive functions in persons with multiple sclerosis: A systematic review and meta-analysis. Mult Scler Relat Disord. 2022 Jun;62:103801. doi: 10.1016/j.msard.2022.103801. Epub 2022 Apr 10.

  PMID: 35430546 RESULT

• McKay KA, Manouchehrinia A, Berrigan L, Fisk JD, Olsson T, Hillert J. Long-term Cognitive Outcomes in Patients With Pediatric-Onset vs Adult-Onset Multiple Sclerosis. JAMA Neurol. 2019 Sep 1;76(9):1028-1034. doi: 10.1001/jamaneurol.2019.1546.

  PMID: 31206130 RESULT

Central Study Contacts

Yonca Zenginler Yazgan

CONTACT

+905326006294; yoncazenginler@gmail.com

Ayten Alihuseynli

CONTACT

+905057374556; alihuseynliayten@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)