跳至主要内容
临床试验/NCT04882930
NCT04882930已完成不适用

Reproducibility of fNIRS Parameters During Walking in Stroke Patients and Healthy Subjects

Centre Hospitalier Régional d'Orléans3 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年6月29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
入组人数
46
试验地点
3
主要终点
Oxyhemoglobin (HbO) variations during simple walking and during dual task

研究概览

简要总结

Brain activation can be studied using the Functional Near InfraRed Spectroscopy (fNIRS). It was shown that CPF activation during walking and during dual task could be different in stroke patients and in healthy subjects.

To date, fNIRS reliability is not completely established during walking and during dual task. Therefore, this study will examine the reproducibility of fNIRS parameters during simple walking and during dual task in healthy subjects and in stroke patients.

详细描述

A fNIRS system will be used to measure the CPF activation. The subjects will walk at their preferred speed on 10 m 3 times and while doing a cognitive task (dual task) 3 times also (in a random order). The same test will be repeated five minutes later. The fNIRS system will be retired and the same test will be repeated 10 min later.

研究设计

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

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Acute stroke group, subacute stroke group, and control group:
  • •Age 50 to 80 years
  • •Affiliated with a social security plan
  • •Able to walk 20 meters unassisted
  • •Acute Stroke and Subacute Stroke Group:
  • •Stroke onset less than 14 days (for the acute stroke group) or between 14 days and 6 months (for the subacute stroke group)
  • •Stroke located in the left or right middle cerebral artery.

排除标准

  • •Acute stroke group, subacute stroke group, and control group:
  • •Person under guardianship or curatorship
  • •Refusal to sign informed consent
  • •Known rheumatologic or cardiologic history
  • •Medication that alters the vigilance and may affect walking (high dose psychotropic drugs, antispastic drugs).
  • •Acute stroke group and subacute stroke group:
  • •History of symptomatic stroke
  • •Previous neurological disease limiting gait, aphasia or impaired cognitive function (mild cognitive dementia, Alzheimer's or Parkinson's disease)
  • •Ambulatory functional category < 3
  • •Control group: neurological medical history

研究组 & 干预措施

Functional Near-Infrared Spectroscopy (fNIRS) acquisitions

Experimental

The hemodynamic response in CPF will be measured using an Octomon+ system (Artinis). Eight emission and two detector probes will be arranged on the participant's forehead.

干预措施: Functional Near-Infrared Spectroscopy (fNIRS) (Procedure)

结局指标

主要结局

Oxyhemoglobin (HbO) variations during simple walking and during dual task

时间窗: Day 0

HbO will be measured by the NIR spectrometry technique continuously at rest and during walking. This technique allows to measure the variations of HbO concentration by measuring the variations of light absorption by the explored tissues.

Deoxyhemoglobin (HbR) variations during simple walking and during dual task

时间窗: Day 0

HbR will be measured by the NIR spectrometry technique continuously at rest and during walking. This technique allows to measure the variations of HbR concentration by measuring the variations of light absorption by the explored tissues.

次要结局

  • Oxyhemoglobin (HbO) variations of acute stroke patients(Day 0)
  • Oxyhemoglobin (HbO) variations using different mathematical treatments.(Day 0)
  • Deoxyhemoglobin (HbR) variations of acute stroke patients(Day 0)
  • Deoxyhemoglobin (HbR) variations of subacute stroke patients(Day 0)
  • Oxyhemoglobin (HbO) variations of subacute stroke patients(Day 0)
  • Deoxyhemoglobin (HbR) variations using different mathematical treatments.(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验