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临床试验/NCT04747587
NCT04747587已完成不适用

Non-use après Accident Vasculaire cérébral : Influence de la Force et de la précision du Geste à Fournir Lors Des Mouvements du Membre supérieur parétique

Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2021年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
4
主要终点
Evaluate the modifications of the proximal non-use after stroke on the paretic side according to the extent of force constraint

研究概览

简要总结

After a stroke, 80% of patients have an upper limb deficit, limiting activity. Some develop a non-use: they can, but do not, use their paretic limb. Non-use is a general phenomenon applied to all situations where the patient applies unnecessary compensation. Several rehabilitation techniques are effective to counter non-use, but there is insufficient knowledge to choose the most suitable technique. Optimal control theory could help guide these choices. It assumes that the chosen coordination satisfies the constraints of the task (force, amplitude, tolerance) while reducing the cost of the movement. This study will assess non-use by anticipating the sensitivity to the constraints of force and precision deduced from the logic of optimal control. The study authors expect to observe a weakness effect: in a reaching task (i.e. when the person has to touch an object placed in front of them), lightening the paretic arm makes it possible to reduce non-use, and a precision effect: in a reaching task, non-use increases with the required spatial precision.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • Inclusion criteria specific to the stroke group:
  • Patient having had a 1st stroke
  • Patient whose stroke occurred more than a month ago.
  • Patient having had a supratentorial stroke
  • Patient able to touch the opposite knee with the paretic arm
  • Inclusion criteria specific to the control group:
  • Subject who has never had a stroke
  • Subject without motor or orthopedic impairment of the upper limbs and in particular of the shoulder
  • General inclusion criteria:
  • Subject who has given free and informed consent.
  • Subject who signed the consent form.
  • Subject affiliated or beneficiary of a health insurance plan.

排除标准

  • Pregnant, parturient or breastfeeding subject.
  • The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient with cognitive disorders incompatible with a good understanding of the use of the device
  • Patient with other neurological or osteoarticular history that may limit the performance of the task - criterion left to the deiscretion of the investigator

结局指标

主要结局

Evaluate the modifications of the proximal non-use after stroke on the paretic side according to the extent of force constraint

时间窗: Inclusion

Proximal Arm Non Use (PANU) score (%): A significant PANU (\> 7.5%) indicates non-use

次要结局

  • Evaluate the modifications of the proximal non-use in the control subjects according to the constraints of force or precision(Inclusion)
  • Intensity of arm deficit(Inclusion)
  • height of the target(Inclusion)
  • Model the constraints and costs explaining non-use patient by patient, to distinguish between physiological and psycho-behavioral non-use(Inclusion)
  • Evaluate the level of neuromuscular activation during reaching(Inclusion)
  • Time since stroke (acute, subacute or chronic phase)(Inclusion)
  • Evaluate the modifications of the proximal non-use after stroke on the paretic side according to the precision required(Inclusion)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (4)

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