跳至主要内容
临床试验/NCT06116006
NCT06116006已完成不适用

fNIRS Study of Effort-dependent Brain Activations During Pointing Movements of the Upper Limb in Post-stroke Patients and Healthy Subjects

Clinique Les Trois Soleils1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年1月15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
64
试验地点
1
主要终点
Change of oxyhemoglobin concentration during upper limb tasks

研究概览

简要总结

Background: Following a stroke, as part of neurorehabilitation, the intensity of effort is important to promote neural changes and stimulate motor recovery. There are few studies concerning the cortical activity involved at different levels of intensity during upper limb motor training.

Objective: To investigate cortex activation while walking an exoskeleton with 4 levels of guidance force in healthy controls.

详细描述

Upper limb paresis is the most common motor deficit following a stroke, and its long-term persistence has an impact on patients' functional recovery and quality of life. Rehabilitation is therefore a major challenge in restoring functional independence.

New physical treatments have been developed over the last 20 years to optimize motor relearning by intensifying motor rehabilitation; among them, therapy using robotic devices has shown its effectiveness in reducing motor deficits.

This therapy offers various options ranging from assistance to movement resistance, which modulates the intensity of effort required of patients during target-pointing exercises.

The brain mechanisms involved in this type of rehabilitation remains imperfectly understood.

Functional neuroimaging techniques such as magnetic resonance imaging (fMRI), positron emission tomography (PET) and functional near-infrared spectroscopy (fNIRS) provide important information on brain activation induced by external stimuli. Among these, fNIRS is a non-invasive method for measuring hemodynamic responses associated with activation of the cerebral cortex. It enables the study of cerebral neurovascular coupling, and is based on the fact that an activated cerebral region increases its oxygen consumption and thus local blood volume and flow.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •For stroke subjects
  • •Age ≥18 years;
  • •Stroke-induced hemiparesis, chronic phase (>6 months post-stroke);
  • •Moderate upper limb paresis defined by an upper limb FMA score 20 pts < FMA score < 47 pts ;
  • •Right-handed patient;
  • •Patient having agreed to sign an informed consent form;
  • •Patient affiliated to the French social security system.
  • •For healthy subjects
  • •Age-matched participant, for each stroke subject included will be associated a control subject of the same age (to the nearest 5 years);
  • •Right-handed participant;
  • •Participant having agreed to sign an informed consent form;
  • •Participant affiliated to the French social security system.
  • •NON-INCLUSION CRITERIA
  • •For stroke subjects
  • •Cognitive impairment making participation in the study impossible;
  • •Phasic disorders preventing comprehension of instructions and effective communication.
  • •For healthy subjects
  • •Pathology of the dominant upper limb;
  • •Cognitive disorders making participation in the study impossible;
  • •Presence of labelled or unlabelled neurological disorders;
  • •Persons under legal protection.

排除标准

  • 未提供

研究组 & 干预措施

Subjects with 3 experimental conditions

Other

3 types of upper limb pointing movements:

  • movements with robot assistance
  • movements without robot assistance
  • movements with robot resistance

干预措施: Upper limb pointing movements in 3 experimental conditions (Other)

结局指标

主要结局

Change of oxyhemoglobin concentration during upper limb tasks

时间窗: Day 0

Change of desoxyhemoglobin concentration during upper limb tasks

时间窗: Day 0

次要结局

未报告次要终点

研究者

发起方
Clinique Les Trois Soleils
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

fNIRS Study of Effort-dependent Brain Activations... | 临床试验