Cognitive-motor Telerehabilitation in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Change in Digit span backwards
研究概览
简要总结
The primary goal of this project is providing evidence that a home-based combined cognitive-motor training program improves cognition in persons with multiple sclerosis (MS), compared to single cognitive and motor rehabilitation. Secondary goals are to assess the effects on walking performance and to identify the mechanisms of improvement and predictors of treatment response. The main backbone of this project will be a randomized controlled two-centre clinical trial, in which an at-home computerised cognitive-motor rehabilitation program using telemedicine aimed at improving working memory in persons with MS will be evaluated. Based on the information gathered during this trial, possible mechanisms of improvement will be identified by analysing anatomical and neurophysiological changes on structural MRI and resting-state and task-related EEG before and after rehabilitation. Furthermore, factors that can predict treatment response to the rehabilitation program will be identified.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study will be double-blinded: patients will not be made aware of the rationale and predictions of the study. The teleconsultations will be carried out by a trained MS nurse, while the baseline and follow-up testing and analyses are carried out by an investigator who is blinded to the treatment allocation of the patients.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically definite multiple sclerosis (revised McDonald criteria 2017)
- •Expanded Disability Status Scale (EDSS) below 6.0
- •Digit span backwards z-score between [-3 and -0.5] standard deviations below the median of the normative values
- •Age between 18 and 65
- •Able to safely perform motor rehabilitation in the home situation (assessed by rehabilitation physician and/or occupational or physiotherapist)
排除标准
- •Cognitive rehabilitation within six months before inclusion
- •Inpatient multidisciplinary rehabilitation program within three months before inclusion or planned inpatient program during trial
- •Start of or switch in immunomodulator treatment within three months before inclusion
- •Less than one month post-exacerbation
- •Major psychiatric or medical disorder that could influence cognitive functions
- •Combined vision with optimal correction below 0.6 on Snellen Visual Acuity Test
- •Unable or unwilling to undergo EEG or MRI
- •Refusing informed consent
研究组 & 干预措施
Motor training group
干预措施: Motor training (Behavioral)
Cognitive-motor training group
干预措施: Cognitive training (Behavioral)
Cognitive-motor training group
干预措施: Motor training (Behavioral)
Cognitive training group
干预措施: Cognitive training (Behavioral)
结局指标
主要结局
Change in Digit span backwards
时间窗: 0 weeks, 12 weeks, 24 weeks, 64 weeks
Measure of working memory
次要结局
- Change in Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)(0 weeks, 12 weeks, 24 weeks, 64 weeks)
- Change in Corsi backwards(0 weeks, 12 weeks, 24 weeks, 64 weeks)
- Change in Expanded Disability Status Scale (EDSS)(0 weeks, 12 weeks, 24 weeks, 64 weeks)
- Change in 6-Minute Walk Test (6MWT)(0 weeks, 12 weeks, 24 weeks, 64 weeks)
- Change in 25-Foot Walk Test (25FWT)(0 weeks, 12 weeks, 24 weeks, 64 weeks)
- MRI T1 3D BRAVO scan(0 weeks, 12 weeks, 24 weeks)
- Change in 9-Hole Peg Test (9HPT)(0 weeks, 12 weeks, 24 weeks, 64 weeks)
- MRI T2 FLAIR 3D Cube scan(0 weeks, 12 weeks, 24 weeks)
- Diffusion weighted image (DWI)(0 weeks, 12 weeks, 24 weeks)
- Synthetic MRI(0 weeks, 12 weeks, 24 weeks)
- resting-state EEG(0 weeks, 12 weeks)
- task-related EEG - auditory oddball paradigm(0 weeks, 12 weeks)
- task-related EEG - adjusted SDMT paradigm(0 weeks, 12 weeks)
- task-related EEG - n-back paradigm(0 weeks, 12 weeks)