跳至主要内容
临床试验/NCT03608527
NCT03608527已完成不适用

The Impact of Motor Rehabilitation on the Dynamic Properties of the Brain: Towards the Individual Tailoring of Therapeutic Interventions in Multiple Sclerosis Patients

Fondazione Italiana Sclerosi Multipla0 个研究点目标入组 30 人开始时间: 2013年9月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Change in the time to perform the Nine Hole Peg Test (NHPT)

研究概览

简要总结

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Active motor treatment (AMT) group

Experimental

15 people with multiple sclerosis performing a 8 week rehabilitative treatment based on task-oriented voluntary exercises (3 sessions/week).

干预措施: Voluntary-based upper limb motor rehabilitation (Behavioral)

Passive motor treatment (PMT) group

Active Comparator

15 people with multiple sclerosis performing a 8 week passive mobilization delivered by a physical therapist (3 sessions/week).

干预措施: Passive upper limb mobilization (Behavioral)

结局指标

主要结局

Change in the time to perform the Nine Hole Peg Test (NHPT)

时间窗: 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.

次要结局

  • Grip and pinch strength(Baseline and 8 weeks)
  • Brain activity (blood-oxygenation-level dependent signal)(Baseline and 8 weeks)
  • Score obtained at the Action Research Arm Test (ARAT)(Baseline and 8 weeks)

研究者

发起方
Fondazione Italiana Sclerosi Multipla
申办方类型
Other
责任方
Sponsor

相似试验

Adaptive Plasticity Following Rehabilitation in... | 临床试验