Pediatric-Onset Multiple Sclerosis (POMS)DTT-POMSNCT07571304
Dual-Task Training in Pediatric Multiple Sclerosis
A study testing Dual-Task Exercise Training and Conventional Functional Exercise Training in people with Pediatric-Onset Multiple Sclerosis (POMS), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pediatric-Onset Multiple Sclerosis (POMS)
- What is being tested?
- Dual-Task Exercise Training and Conventional Functional Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey
Istanbul, 34000
Aytan Alihuseynli, +905057374556, alihuseynliayten@gmail.com
Aytan Alihuseynli
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Dual-Task Exercise Training, Conventional Functional Exercise Training
- Keywords
- Pediatric-Onset Multiple Sclerosis, Dual Task, Dual Task Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task Exercise TrainingBehavioural
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
Conventional Functional Exercise TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Conventional Functional Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and at 8 weeks
Secondary outcomes (5)
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).
Measured: Baseline and at 8 weeks
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.
Measured: Baseline and at 8 weeks
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).
Measured: Baseline and at 8 weeks
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).
Measured: Baseline and at 8 weeks
Multiple Sclerosis Functional Composite (MSFC)
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.
Measured: Baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Apr 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pediatric-Onset Multiple Sclerosis (POMS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayten Alihuseynli, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571304
- Sponsor's protocol ID
- 2026/38
- Acronym
- DTT-POMS
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31049039Weikert 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.
PubMed 20060544Grover 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.
PubMed 27717498Sebastiao 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.
PubMed 26944709Wollesen 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.
PubMed 35091209Beste 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.
PubMed 29445335Ekici 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.
PubMed 40737966ATS 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.
PubMed 12091180Fischer 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.
PubMed 10467383Varni 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.
PubMed 11468499Ozakbas 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.
PubMed 29207954Abasiyanik 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.
PubMed 35430546McKay 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.
PubMed 31206130
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual-Task Training on Motor and Cognitive Functions in Pediatric-Onset Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT07571304
- Acronym / sponsor ID
- DTT-POMS / 2026/38
- Keywords
- Pediatric-Onset Multiple Sclerosis, Dual Task, Dual Task Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-Task Exercise Training | Experimental | Behavioral: Dual-Task Exercise TrainingParticipants 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 |
| Conventional Functional Exercise Training | Experimental | Behavioral: Conventional Functional Exercise TrainingParticipants 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Task Exercise TrainingThis 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 | Behavioural | Dual-Task Exercise Training |
| Conventional Functional Exercise TrainingThis 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. | Behavioural | Conventional Functional Exercise Training |
Primary outcome
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery
Time frame: 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.
6-Minute Walk Test
Time frame: 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.
5 secondary outcomes
Mini-BESTest
Time frame: Baseline and at 8 weeks
Timed Up and Go Test (TUG)
Time frame: Baseline and at 8 weeks
PedsQL Multidimensional Fatigue Scale
Time frame: Baseline and at 8 weeks
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline and at 8 weeks
Multiple Sclerosis Functional Composite (MSFC)
Time frame: Baseline and at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 31049039Sikes 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.
- Results publication: PubMed 20060544Weikert 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.
- Results publication: PubMed 27717498Grover 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.
- Results publication: PubMed 26944709Sebastiao 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.
- Results publication: PubMed 35091209Wollesen 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.
- Results publication: PubMed 29445335Beste 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.
- Results publication: PubMed 40737966Ekici 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.
- Results publication: PubMed 12091180ATS 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.
- Results publication: PubMed 10467383Fischer 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.
- Results publication: PubMed 11468499Varni 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.
- Results publication: PubMed 29207954Ozakbas 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.
- Results publication: PubMed 35430546Abasiyanik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Task Exercise Training and Conventional Functional Exercise Training in people with Pediatric-Onset Multiple Sclerosis (POMS), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yonca Zenginler Yazgan (+905326006294, yoncazenginler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery (time frame: Baseline and at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07571304, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.