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临床试验/NCT04809987
NCT04809987已完成不适用

Evaluation of Effectiveness of Virtual Gait System Intervention in Motor Function, Tone and Sensibility, in People With Incomplete Spinal Cord Injury.

University of Valencia4 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
4
主要终点
Gait

研究概览

简要总结

Roughly 60% of people with Spinal Cord Injury (SCI) have an incomplete one, with a strength, sensibility, and muscle tone alteration. Moreover, this condition involves a high impact on the psychological and socioeconomic levels.

After an incomplete SCI, spontaneous functional recovery occurs. This recovery is strong associated with injury and person characteristics, and with corticospinal fibers, motor cortex, and spinal neurons neuroplasticity. However, also it is possible to stimulate neuroplasticity mechanisms of these structures throughout rehabilitation techniques. Generally, with external devices, exoskeletons, or physical exercise therapy. With it, clinicians achieve early, intensive and specific therapies.

This reorganization and recovery can be influenced because of mirror neurons, located in motor and premotor areas, and in other cortical and subcortical areas. These types of neurons are activated with a functional action observation.

Due to incomplete SCI neuroplasticity recover, these therapies (concretely, illusion visual systems) have been the object of systematic review in this population with the aim of knowing its repercussion on neuropathic pain in chronic patients. Moseley and collaborators in 2007 were the first of proposing a virtual gat system that induced patients' gait illusion. The promising results in this intervention, leading institutions performed similar studies with other stimuli and devices, with good results.

However, SCI studies are focused on neuropathic pain and not in motor function (like in other populations). Therefore, there is not any study that assesses mirror neurons activity in the physical condition and/or in functional gait capaity in incomplete spinal cord injury population.

On the basis of the above, the study principal aim is to evaluate a virtual gait treatment effectiveness compared with combined interventions with specific gait physical exercise in functional capacity in the incomplete spinal cord injury population. Concretely in follow outcomes: gait, functionality, strength, muscle tone, sensibility, and neuropathic pain.

详细描述

Roughly 60% of people with Spinal Cord Injury (SCI) have an incomplete one, with a strength, sensibility, and muscle tone alteration. Moreover, this condition involves a high impact on the psychological and socioeconomic levels.

After an incomplete SCI, spontaneous functional recovery occurs. This recovery is strong associated with injury and person characteristics, and with corticospinal fibers, motor cortex, and spinal neurons neuroplasticity. However, also it is possible to stimulate neuroplasticity mechanisms of these structures throughout rehabilitation techniques. Generally, with external devices, exoskeletons, or physical exercise therapy. With it, clinicians achieve early, intensive and specific therapies.

This reorganization and recovery can be influenced because of mirror neurons, located in motor and premotor areas, and in other cortical and subcortical areas. These types of neurons are activated with a functional action observation. Mirror neurons activity has been studied with several brain injury populations (Cranial traumatisms, Parkinson, or Alzheimer's disease). Therefore, several experimental investigations have been developed by applying different interventions to modified their activity (mirror therapies, virtual reality therapies, or Action-Observation therapies). Its results showed promising improvements, except for advanced Alzheimer's disease.

Due to incomplete SCI neuroplasticity recover, these therapies (concretely, illusion visual systems) have been the object of systematic review in this population with the aim of knowing its repercussion on neuropathic pain in chronic patients. Moseley and collaborators in 2007 were the first of proposing a virtual gat system that induced patients' gait illusion. The promising results in this intervention, leading institutions performed similar studies with other stimuli and devices, with good results.

However, SCI studies are focused on neuropathic pain and not in motor function (like in other populations). Therefore, there is not any study that assesses mirror neurons activity in the physical condition and/or in functional gait capaity in incomplete spinal cord injury population.

研究设计

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

入排标准

年龄范围
16 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Incomplete spinal cord injury (ASIA C,D or E).
  • Mini-Mental State Examination >23 points.

排除标准

  • Lower limbs traumathic pathology.
  • Other nervous system alterations.
  • Vestibular diseases.
  • Other diseases.

研究组 & 干预措施

Virtual Gait and Physical Exercise

Experimental

干预措施: Physical Exercise (Other)

Virtual Gait and Physical Exercise

Experimental

干预措施: Virtual Gait (Other)

Documental projection and Physical Exercise

Sham Comparator

干预措施: Physical Exercise (Other)

Documental projection and Physical Exercise

Sham Comparator

干预措施: Documental projection (Other)

Virtual Gait

Experimental

干预措施: Virtual Gait (Other)

Documental Projection

Sham Comparator

干预措施: Documental projection (Other)

结局指标

主要结局

Gait

时间窗: 10 minutes

10 meters Walking Test

Functionality

时间窗: 10 minutes

FallSkip

Strength

时间窗: 10 minutes

Load Cell

次要结局

  • Neuropathic Pain(10 minutes)
  • Spasticity(10 minutes)
  • Muscle Activation(10 minutes)

研究者

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

Pilar Serra Añó

Chaired Full Professor

University of Valencia

研究点 (4)

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