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临床试验/NCT04449328
NCT04449328终止不适用

Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
33
试验地点
1
主要终点
subjective measure of the intensity of the perception of movements: change from baseline impression of movement at day 7

研究概览

简要总结

Two movement illusion techniques can currently be used in clinical practice for motor rehabilitation after stroke hemiplegia: visual illusion (mirror therapy) and proprioceptive illusion (tendon vibration). Mirror therapy, in its computerized version (IVS3, Dessintey, Saint-Etienne, France), is based on the substitution of the deficient visual feedback by a visual feedback of a correctly realized movement. The proprioceptive illusion is based on the external application of a vibrator on muscle tendons at a frequency between 50 and 120 Hz. These two techniques are currently used independently. They are, in theory, complementary and additive. No study has described the combinatorial properties of the illusions generated by these 2 techniques in hemiplegic subjects and healthy subjects.

详细描述

The study hypothesis is that the administration of mirror therapy together with vibration will increase the perception of movement in a subjective scale.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hemiplegic subjects :
  • Male or female
  • Aged 18 to 70 years,
  • First ischemic or hemorrhagic stroke causing hemiplegic
  • Having signed the written consent
  • Affiliated or entitled to a social security scheme
  • Healthy subjects :
  • Male or female, aged 18 to 70 years,
  • Matched in sex, age and laterally with hemiplegic subjects
  • Having signed the written consent
  • Affiliated or entitled to a social security scheme

排除标准

  • Hemiplegic subjects :
  • With complete lesion of the primary motor cortex
  • With an addiction to alcohol or drugs
  • With psychiatric illness, cognitive impairment, uncontrolled disease/epilepsy, malignant illness severe kidney or lung disease
  • With history of associated general disabling disease
  • With cerebellar syndrome
  • With clinical brain stem involvement
  • Under legal protection
  • Pregnant or breastfeeding women
  • Healthy subjects :
  • Neurological, cardiovascular, musculoskeletal diseases
  • Taking medication that can affect attention
  • Unable to understand instructions of the study
  • Under legal protection
  • Pregnant or breastfeeding women

结局指标

主要结局

subjective measure of the intensity of the perception of movements: change from baseline impression of movement at day 7

时间窗: Day: 0, 7

Measured impression of movement on conditions (visual and/or proprioceptive; yes/no/don't know)

subjective measure of the intensity of the perception of movements: change from baseline nature of this impression at day 7

时间窗: Day: 0, 7

Measured nature of this impression of movement (flexion/extension)

subjective measure of the intensity of the perception of movements: change from baseline intensity of the movement felt at day 7

时间窗: Day: 0, 7

Measured intensity of the movement felt by Visual Analogue Scale (VAS) results (0 = no sense of movement and 10 = like real movement.)

次要结局

  • Brain activity according to different experimental conditions (with and without vibration or with and without visual illusion) in hemiplegic subjects.(Day: 0, 7)
  • Objective measurement of the perceived movement angle reproduced without motor intention by the hemiplegic subjects with the healthy limb(Day: 0, 7)
  • To compare the Visual Analogue Scale (VAS) score according to the level of motor impairment(Day: 0)
  • To compare the Visual Analogue Scale (VAS) score with the Erasmus modified Nottingham Sensory Assessment (EmNSA) score(Day: 0)
  • Measurement of motor intention in hemiplegic subjects by experimental conditions(Day: 0, 7)
  • Intensity of the perception of movements using a visual analogue scale and the objective measurement of perceived movement angle reproduced by the healthy subjects with the vibrated arm(Day: 0, 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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