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Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients. (FINGER)

2018年3月8日 更新者:Centre Hospitalier Universitaire de Nice

Sensory disorders in patients with multiple sclerosis are among the most common symptoms encountered.

A functional impairment based on sensory disorders of the hand. The hand is a sensory organ that transmits the cerebral cortex protopathic sensitive information, proprioceptive or epicritiques. The view-hand association plays an important role in the understanding of the environment. Its exploratory use remains an essential and voluntary basis. The process of recognition of the object passes through manipulation, but operates instantaneously. The brain is able to do a quick summary of the information it receives to determine the nature of the manipulated object. The exploration takes a posteriori, the brain can then determine the details component object (texture, shape, composition, temperature and weight).

Neurophysiological mechanisms that would explain the analgesic effects of transcutaneous electrical nerve stimulation (TENS) are not fully understood. Several theories underlying its use as a neuromodulator of pain. The gate control theory has led to the development of TENS devices. Recruitment of myelinated, large caliber, by the TENS electrodes afferent fibers increases the control exerted on spinal level, thereby inhibiting the action of afferent fibers of small caliber related to nociception. This stimulation strengthens the blocking of "gate" at the corresponding cell bodies of spinothalamic tract and reduces the transmission of nociceptive impulses to the spinal cord dorsal horn. This is segmental presynaptic inhibition depends on the area and stimulated.

The objective of this study is to improve the quality of life through improved sensitivity disorders of the hand in patients with MS, thanks to reeducation of the hand.

研究概览

研究类型

介入性

注册 (实际的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Nice、法国、06000
        • Hôpital Pasteur

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients with relapsing remitting MS defined according to Poser criteria [9] and McDonald [5].
  • Age ≥ 18 years, male or female sex
  • Patients with sensory disorders interesting hands, evidenced by clinical examination objective.
  • Patients with an EDSS between 2 and 4 with functional sensitivity parameter ≥ 2.
  • Patients affiliated to a social security scheme.
  • Patients signed informed consent for the study.

Exclusion Criteria:

  • Patients with other central or peripheral disorders may affect the sensitivity of the hand.
  • Patients with allodynia in the study area
  • Patients with a motor and / or deficit cerebellar ataxia of the upper limbs.
  • Patients treated with psychotropic or antiepileptic drugs.
  • Patients for whom a flare occurred affecting the sensitivity of the hand, within 30 days before enrollment.
  • Patients holders of an active implantable medical device.
  • Pregnant women and vulnerable patient population.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:A group enjoying a corrective touch

At first, the patient is asked to gradually define the different types of touch that is applied to the hyposensitive area (fixed or mobile touches) with different textures and then compare them with the healthy side. In a second step, the patient is asked to associate multiple items sensation shape and texture, shape and weight. In a third step is used everyday objects.

Desensitisation techniques find their interest mainly when symptoms or dysesthetic hyperesthésique. The objective is to increase the threshold of sensitivity to textures and particles eventually reduce dysaesthetic sensations.

The patient class in order of increasing tolerance 10 textures. Dysesthetic area is stimulated 5 to 10 minutes by the first texture to numb the area by saturation of the action potential. This helps promote functional work and recognition of objects. As soon as the texture causes more trouble we go to the next texture by applying the same job.

实验性的:A group receiving TENS (TENS)
Well known in the management of neuropathic pain based on the gate control theory, the application of TENS in the rehabilitation of touch remains to be demonstrated. A recent study applied to the September highlighted the long-term interest of the transcutaneous electrical nerve stimulation (TENS) to improve sensitivity tact arguing possible action on brain plasticity.
无干预:A control group

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Compare quality of life between baseline and procedure
大体时间:frist day, 1 month and 3 month

Improve the quality of life through improved sensitivity disorders of the hand in patients with MS, thanks to reeducation of the hand.

Unit of mesure: scale MusiQoL

frist day, 1 month and 3 month

次要结果测量

结果测量
措施说明
大体时间
Compare the performance during functional tests between baseline and procedure
大体时间:first day, 1 month and 3 month

Improve performance of MS patients during functional tests in patients undergoing rehabilitation treatment compared to the control group.

Using picking up test and thr Nine Hole Peg Test

first day, 1 month and 3 month
Compare the improvement clinically sensitive target from baseline procedure
大体时间:first day, 1 month and 3 month

Improve clinically sensitive target of MS patients through a rehabilitation treatment compared to the control group.

Using the Threshold pressure, the Threshold to the vibration and the Weber test.

first day, 1 month and 3 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Mikael COHEN, Medical Doctor、Centre Hospitalier Universitaire de Nice

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年7月30日

初级完成 (实际的)

2015年7月28日

研究完成 (实际的)

2015年7月28日

研究注册日期

首次提交

2013年4月30日

首先提交符合 QC 标准的

2013年5月27日

首次发布 (估计)

2013年6月3日

研究记录更新

最后更新发布 (实际的)

2018年3月12日

上次提交的符合 QC 标准的更新

2018年3月8日

最后验证

2018年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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