The Effect of Dual-Task Training on Motor and Cognitive Functions in Pediatric-Onset Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Dual-Task Exercise Training (Behavioral)
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.
干预措施: Conventional Functional Exercise Training (Behavioral)
结局指标
主要结局
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Ayten Alihuseynli
Physiotherapist
Istanbul University - Cerrahpasa