Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
The Impact of Motor Rehabilitation on the Dynamic Properties of the Brain: Towards the Individual Tailoring of Therapeutic Interventions in Multiple Sclerosis Patients
Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. For example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. However, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined.
Moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks.
Therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. Particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Multiple sclerosis diagnosis according to McDonald criteria
- right handedness as assessed by the Edinburgh Handedness Inventory
- absence of relapses in the last three months
- mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the Medical Research Council scale (grade 3-4)
Exclusion Criteria:
- steroid-use or a worsening of the Expanded Disability Status Scale (EDSS) score in the last three months
- psychiatric disorders
- severe cognitive impairment
- magnetic resonance imaging contraindications
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Active motor treatment (AMT) group
15 people with multiple sclerosis performing a 8 week rehabilitative treatment based on task-oriented voluntary exercises (3 sessions/week).
|
Exercises for neuromuscular control to improve proprioceptive sensibility, muscle strength, stability and coordination of the upper limbs, mainly including task-oriented movements with the goal to improve activities of daily living.
Both proximal and distal muscles are involved, in actions such as grasping wooden cubes of different sizes, pinching, reaching targets displayed in front of the patient, and doing patchwork or paper mandala.
|
|
有源比较器：Passive motor treatment (PMT) group
15 people with multiple sclerosis performing a 8 week passive mobilization delivered by a physical therapist (3 sessions/week).
|
Passive mobilization delivered by a physical therapist of shoulder, elbow, wrist and fingers without detectable muscle activity.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the time to perform the Nine Hole Peg Test (NHPT)
大体时间：Baseline and 8 weeks
|
The NHPT is a brief, standardized, quantitative test of upper extremity function, requiring participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible.
|
Baseline and 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Score obtained at the Action Research Arm Test (ARAT)
大体时间：Baseline and 8 weeks
|
The Action Research Arm Test is an observational measure used to assess upper extremity performance (coordination, dexterity and functioning).
The scale ranges from 0 to 57, with higher scores indicating better outcomes.
Items are categorized into four subscales: grasp (score 0-18) , grip (0-12), pinch (0-18) and gross movement (0-9) which are arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task.
|
Baseline and 8 weeks
|
|
Grip and pinch strength
大体时间：Baseline and 8 weeks
|
Force applied by the hand and the fingers measured by means of specific dynamometers
|
Baseline and 8 weeks
|
|
Brain activity (blood-oxygenation-level dependent signal)
大体时间：Baseline and 8 weeks
|
Task-related brain activations assessed by means of functional magnetic resonance imaging during a finger-to-thumb opposition sequence
|
Baseline and 8 weeks
|
合作者和调查者
调查人员
- 首席研究员：Marco Bove, Prof、University of Genoa
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- FISM 2011R8
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.