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临床试验/NCT03094572
NCT03094572Unknown不适用

Evaluation of the Visual Motor Task's Impact on the Behavior of a Neuronal and Spinal Network in Hemiplegic Patients

Centre d'Investigation Clinique et Technologique 8052 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2017年7月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
64
试验地点
2
主要终点
Hoffmann's reflex amplitude

研究概览

简要总结

The general objective being to determine the modifications nature induced by upper extremity kinematic rhythmic task realization on cervical HSCC.

The obtained knowledge could open up new prospects for rehabilitation in cerebro-injured subjects in addition to existing therapeutics.

详细描述

Half of all stroke patients have physical disabilities. These disabilities combine sensory and motor deficiencies (control deficit, syncinesia, tone disorders) that cause disruption of upper extremity (UE) function (orientation, UE length adjustment and grip). The human spinal cord circuitry (HSCC) participate in the motion regulation. Roche et al. studied in healthy subjects the HSCC modifications during the visuo-motor regulation of the object clamping force by the hand. The authors showed that the learning of the task in a single session was associated with HSCC modifications, specific or not depending on the HSCC and according to a visual biofeedback associated or not to the task. Diserens et al. showed also that a rhythmic movement of UE pedaling causes a decrease in spasticity in hemiplegic subjects. Moreover, HSCC modification is dependent on the task performed. The rhythmic ball-bouncing in a virtual environment is a visuo-motor task rhythmic kinematic already studied in the healthy subject. To our knowledge, the present study is the first to investigate HSCC modification in hemiplegic subjects performing a rhythmic kinematic task with UE. We hypothesize that such a task leads to HSCC excitability specific modifications in the cervical spinal cord and leads to an improvement in the motor capabilities of the subjects.

The general objective being to determine the modifications nature induced by UE kinematic rhythmic task realization on cervical HSCC, our research will be broken down into four studies.

Study 1 will identify the influence of visual feedback on changes in HSCC excitability in a voluntary group. In this first study, 16 voluntary subjects will perform the visuo-motor task with their dominant UE and the control task (without visual feedback) with their dominant UE.

Study 2 will investigate the impact of UE laterality which performing the task on changes in HSCC excitability in a voluntary group. In this second study, 16 volunteer subjects will perform the visuo-motor task with their dominant UE and the visuo-motor task with their non-dominant UE.

Study 3 will objectify the effect of the type of contraction of the muscles involved in the task on changes in HSCC excitability in a volunteer group. In this third study, 16 voluntary subjects will perform the visuo-motor task with their dominant UE by performing either elbow flexion-extension or only flexion-extension of the wrist.

研究设计

研究类型
Interventional
分配方式
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

  • Hemiplegic subjects:
  • Informed consent signature,
  • Male or female aged 18 years or over,
  • Hemiplegic patient with single stroke,
  • Patient able to stand without technical assistance,
  • Patient capable of performing an active elbow flexion/extension movement of an amplitude of at least 45° against gravity,
  • Patient able to understand and realize the cyclical kinematic rhythmic task.
  • Absence of cognitive impairment, Mini-Mental State score (MMS) equal to
  • Voluntary subjects:
  • Informed consent signature,
  • Male or female aged 18 years or over,

排除标准

  • Hemiplegic subjects:
  • Refusal to participate in the study,
  • Inability to cooperate,
  • Intervention on the studied upper limb dating less than 6 months,
  • No affiliation to a social security scheme,
  • No H-reflex in the muscle Flexor Carpi Radialis,
  • Epilepsy antecedent.in the year prior to inclusion.
  • Voluntary subjects:
  • Refusal to participate in the study,
  • Inability to cooperate,
  • Intervention on the studied upper limb dating less than 6 months,
  • No affiliation to a social security scheme,
  • No H-reflex in the Flexor Carpi Radialis muscle,
  • Ambidextrous subject,
  • Epilepsy antecedent.

结局指标

主要结局

Hoffmann's reflex amplitude

时间窗: 2h

amplitude modification of the hoffmann's reflex

次要结局

  • bell's test(15 min)
  • modified Ashworth scale(15 min)
  • fugl meyer test(40 min)
  • kinematic performance of the rhythmic task(20 min)
  • MRC testing(30 min)

研究者

发起方
Centre d'Investigation Clinique et Technologique 805
申办方类型
Other
责任方
Sponsor

研究点 (2)

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