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临床试验/NCT03191032
NCT03191032已完成不适用

Cortical and Functional Responses to an Early Protocol of Sensory Re-education of the Hand Using Audio-tactile Interaction

University of Sao Paulo0 个研究点目标入组 17 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
主要终点
Sensory Threshold - Mann Whitney non-parametric test

研究概览

简要总结

The implementation of early sensory re-education (SR) techniques, aimed to preserve the cortical hand area, such as the use of audio-tactile interaction, becomes an important strategy to obtain also a better sensory function. The aim of this study was to investigate sensory function outcomes (threshold monofilaments, two-point discrimination test, STI and DASH) and cortical responses (fMRI) in patients submitted to an early protocol of SR of the hand with a sensor glove model. After surgical repair of median and/or ulnar nerves, 17 participants were divided into two groups: the training group, trained on the protocol with the sensor glove model, and the control group, untrained. After six-month follow-up, no difference was observed between groups, related to sensory function, especially tactile gnosis. Despite this, the early training with this sensor glove model seems to provide some type of cortical audio-tactile interaction, contributing to previous studies that focus in early SR of the hand using the integration of different sensory modalities.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Injury of the ulnar and/or median nerves at the wrist or distal forearm level surgically repaired

排除标准

  • Neurological diseases
  • Systemic diseases, which affected either directly or indirectly the central or peripheral nervous system
  • Extensive traumas in the upper limbs

结局指标

主要结局

Sensory Threshold - Mann Whitney non-parametric test

时间窗: First, Third and Sixth month post-operative

Sensory Threshold was assessed by esthesiometry at first, third and sixth month post-operative

Tactil Gnosis - Mann Whitney non-parametric test

时间窗: First, Third and Sixth month post-operative

Tactile Gnosis was assessed by Two-point discrimination and Shape and Texture Identification Test at first, third and sixth month post-operative

Cortical responses - fMRI data analysed by Granger Causality Map

时间窗: Three months

Training group subjects were submitted to fMRI exam at third month post-operative

Self-report function - Mann Whitney non-parametric test

时间窗: First, Third and Sixth month post-operative

Self-report function was assessed by DASH questionnaire at first, third and sixth month post-operative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marisa de Cassia Registro Fonseca

Collaborator

University of Sao Paulo

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