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临床试验/NCT03112616
NCT03112616已完成不适用

The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position and on Spatial Frame Reference in Chronic Stroke Patients

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2016年2月15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
39
试验地点
1
主要终点
Changes from baseline Weight Bearing Asymmetry at Day 15

研究概览

简要总结

One of the causes of disability in patients suffering from a stroke is postural imbalance. Sensory stimulation improves the postural symmetry of the subject transitorily and they are thought to have an effect on the spatial frame of reference through a sensory recalibration. Studies have shown that sensory stimulation by vibration of neck muscles have an immediate effect on static balance and when walking. The objective of this preliminary study is to test the long-lasting effects of repetitive neck muscle vibrations on postural disturbances in standing position and on spatial frame reference in chronic patients.

详细描述

The hypothesis of this study is that the proprioceptive repeated stimulation by vibration of neck muscles in the long term improved postural asymmetry in connection with the egocentric representation of body disorders.

The effect of vibration simultaneously on improving postural asymmetry and on improving markers of the perception of the body in space (LBA, SSA, Subjective Visual Vertical (SVV), Rod and frame) will be assessed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (age ≥ 18 years) under 80 years,
  • Right or left unilateral supratentorial ischemic or hemorrhagic lesion
  • The first symptomatic episode
  • older than 12 months
  • with or without hemianopsia
  • with or without visuospatial hemineglect
  • Standing balance ≥ 30 sec unaided
  • Percentage of weight bearing asymmetry on the hemiplegic lower limb (on a force platform)
  • Written informed consent of the patient or a member of his entourage (in the case of patients with motor difficulties)

排除标准

  • Orthopaedic, rheumatologic, neurologic, vestibular or visual disorders affecting the distribution of the centre of pressure while standing on the force platform
  • Visual disorder that does not allow assessment of the spatial frame of reference test
  • Difficulty with understanding protocol procedures

结局指标

主要结局

Changes from baseline Weight Bearing Asymmetry at Day 15

时间窗: Before and after the intervention program (Day 15)

The primary evaluation criteria is the percentage of the Weight Bearing Asymmetry on the hemiparetic lower limb (WBA) calculated as the mean of 4 trys, each based on a 30 seconds duration with the two eyes open (OP) and then again with the two eyes closed. This evaluation is realized on a force platform.

次要结局

  • Subjective Visual Vertical (SVV) test(7 days and 15 days after the start of the intervention)
  • Change from baseline of patients' spasticity(1 month after the end of the program)
  • Change from baseline of patients' motor skills(1 month after the end of the program)
  • Haptic and visual Subjective Straight Ahead (SSA) test(7 days and 15 days after the start of the intervention)
  • Evaluation of Longitudinal Body Axis (LBA)(7 days and 15 days after the start of the intervention)
  • Rod and Frame Test(7 days and 15 days after the start of the intervention)
  • Change from baseline of patients' functional capacity(1 month after the end of the program)
  • Change from baseline of patients' sensitivity(1 month after the end of the program)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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