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临床试验/NCT01146249
NCT01146249已完成不适用

Evaluation of the Sensorial Preference for Balance Control

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2007年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
1
主要终点
Sensory profile before and after rehabilitation

研究概览

简要总结

Among the components of postural control, sensorial integration is of crucial importance. The most important sensorial inputs for postural maintenance are the vestibular system which provides information regarding accelerations of the head in space (HORAK 1994), the somatosensory system which provides proprioceptive information that are used to determine changes in body position (INGLIS 1994) and the visual system which provides information for self motion in the environment. The receptors and the integration channel of each sensorial system have inner characteristics which lead to different performance of the different input in regards to the task and the environmental context (FITZGERALD 1994). Most of time, sensorial information are congruent but sometimes they are conflicted. This is the case when being in a stationary train, the train beside going on, giving the illusory sensation of movement even if the vestibular system is not activated. A sensory weighting process is then necessary for subjects to control balance. The Central Nervous System (CNS) is thought to adjust the relative contribution of sensory input to control stance depending on environmental conditions (CENCIANNI 2006) and the reliability of the sensory input (OIE 2002, KESHNER 2004) in order to maintain or achieve the desired orientation in space and to provide postural stability. Nevertheless the interconnection of the multiple sensorial feedback involved in the postural control is not yet completely understood (CHIARI 2000).

Today, there is no tool available to evaluate the individual use of the sensorial information to postural control. It seems interesting to have such a tool to better understand the sensorial preference of subjects. It would be of particular importance for patients with various pathologies in the aim to design individualized balance rehabilitation programs.

The aim of the study was to test a tool built to evaluate the sensorial preference of subjects by studying their postural reaction related to the 3 main sensorial perturbations. Normal subjects will be first tested to assess the repeatability of the protocol and to collect normal values. Then, patients with post stroke hemiplegia, vestibular disease, neuropathy and fallers will be studied in order to test the feasibility of the protocol and to have preliminary data of sensorial preference among these populations.

详细描述

Subjects Subjects with balance disorder related to a first hemispheric stroke, or vestibular trouble, or neuropathy and or aging

Apparatus Balance evaluation Subjects stand barefoot on a force platform (FeeTest Technoconcept®) consisting of two separate aluminium plates, distant of 12 cm, each placed on 2 force transducers that recorded the vertical ground reaction forces. The position of the center of pression (COP) was calculated from the ground reaction force. The data are collected with a sampling frequency of 40 Hz.

Sensory disturbance Sensory information (vision, proprioception and vestibular information) are successively disturbed. For each sensory information, different perturbations are tested in order to induce a sway in a determined direction (anterior, posterior, right and left).

Vision is disturbed by an optokinetic stimulation in a dark room, an optokinetic bowl (OPTOTEST, Technconcept®) placed behind the subject projecting moving luminous dots on the wall in front of the subject at the speed of 60/°s. The subjects are instructed to stare straight ahead at the stimulus pattern without attempting to follow the moving dots. Four trials are conducted for the visual stimulation in which the direction of the stimulus pattern differs: the direction of the displacement of the luminous dots is first top to bottom up, then bottom to top down, right to left and finally left to right.

Proprioceptive information is disturbed by a vibratory stimulation: vibration is delivered by two mechanical vibrators (VB 115, TECHNOCONCEPT ®). The vibration is of 1mm amplitude and the frequency is 50 Hz. Vibratory stimulation is first applied on the muscle tendon of the triceps sural, afterwards on the tendon of the tibialis anterior.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • depending on the group
  • Healthy subjects without history of balance disorder
  • Vestibular patients with a unique history of peripheric vestibular disorder
  • Post stroke patients after a unique hemispheric stroke, being able to stand without any help
  • Patient with proprioception disorder related to peripheral neuropathy.
  • Old subjects with a history of falls (one or more during the last year).

排除标准

  • For each category, other disorder than the one studied leading to balance trouble.
  • Neuropsychological troubles preventing comprehension of the tests.

结局指标

主要结局

Sensory profile before and after rehabilitation

时间窗: at month 1

Sensory profile is defined by change in postural control on force plate under, visual, vestibular, and proprioceptive stimulation.

次要结局

  • Activities-specific Balance Confidence scale(at month 1)
  • Area and length of the center of pression displacement during 10sec, closed eyes (assessed during the sensorial tests)(at month 6)
  • Sensory profile before and after rehabilitation(at month 6)
  • Timed up and go(at month 6)
  • Walking distance(at month 6)
  • Area and length of the center of pression displacement during 10sec. open eyes(at month 6)
  • DISEANESS Handicap Inventory scale(at month 1)
  • Berg Balance scale(at month 6)
  • Speed of walk(at month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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