Investigate Neuro-rehabilitation Active Ingredients of Specific Task-oriented Training In People With Multiple Sclerosis With Different Challenging Conditions and Extrinsic Feedbacks
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Head and trunk movements quantified with Inertial Measurement Units (IMU)
研究概览
简要总结
The driving idea of this project is to use new imaging techniques during 0functional movements to study relearning during a typical rehabilitation session.
The novelty of this project is to move from studies inquiring changes in brain activity patterns before and after rehabilitation toward a paradigm in which cortical activity is studied during the execution of the exercise. This would allow better understanding of cortical mechanisms underpinning functional improvements.
The project builds on preceding studies, partially funded by FISM, from the three research units involved in this project, aimed at assessing the impact of rehabilitation on mobility and balance and at assessing the effects of neurorehabilitation on brain plasticity. In this study, we will include 40 healthy subjects and a sample of 20 consecutive People with Multiple Sclerosis (PwMS), and we will investigate brain cortical activity during a typical session of task-oriented exercises. In specific, participants will undergo a treadmill training in which they will be required to keep their trunk and head stable in space using a biofeedback device. To study the effects of the session in improving dynamic stability, Head/trunk movements will be registered by inertial measurement units, while cortical activity will be concurrently assessed by functional near-infrared spectroscopy (fNIRS).
The first phase of the project will include healthy subjects and will be useful to understand the main cortical areas involved in the proposed motor tasks, in order to design the appropriate montage and protocol for fNIRS acquisition in PwMS. Finally, the analysis of the possible differences in cortical activation during different experimental conditions (e.g., biofeedback rehabilitation) in healthy subjects and PwMS will serve to develop a model for neurological rehabilitation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects between 18 and 60 years of age,
- •diagnosis of MS (McDonald criteria, Thompson et al, 2018), stable disease course without worsening more than 1 EDSS point over the last 3 months, EDSS between 3 and 4.5 points,
- •healthy right-handed volunteers,
- •able to release a written informed consent.
排除标准
- •Unable to comprehend the aims of the study and to follow test instructions;
- •Diagnosis of major depression (DSM-5);
- •Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment);
- •Cardiovascular diseases;
- •Severe visual impairments interfering with the execution of the protocol;
- •epilepsy;
- •intake of neuroleptic and antiepileptic drugs.
结局指标
主要结局
Head and trunk movements quantified with Inertial Measurement Units (IMU)
时间窗: Baseline
The following variables are calculated: (1) the angular displacements in the sagittal and frontal planes, calculated as 1 standard deviation (SD) from the angular displacement data; and the head and angular velocities, which are the root mean square of the first derivative of angular displacements in the sagittal and frontal planes.
Cortical activation with Functional Infrared Spettroscopy (fNIRS)
时间窗: Baseline
fNIRS data analysis will identify the acquisition channels (and hence the cortical areas) significantly active in the different experimental conditions.
次要结局
- 10 Meters walking test(Baseline)
- Twelve-Item Multiple Sclerosis Walking Scale (MSWS_12)(Baseline)
- Modified Fatigue Impact Scale (MFIS)(Baseline)
- Beck Depression Inventory (BDI-II)(Baseline)