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Clinical Trials/NCT04809987
NCT04809987
Active, not recruiting
Not Applicable

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

University of Valencia2 sites in 1 country38 target enrollmentJanuary 9, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Incomplete Spinal Cord Injury
Sponsor
University of Valencia
Enrollment
38
Locations
2
Primary Endpoint
Gait
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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. 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. Therefore, this study is a randomized clinical trial in which four groups of twenty people in each group will participate, with different interventions: 1. Virtual Gait and Physical exercise. 2. Documental projection and physical exercise. 3. Virtual Gait. 4. Documental Projection. Data analysis will be performed with SPSS statistic program (v26). Normality and homocedasticity will be analyzed by Shapiro-Wilk t-test and Levene test, respectively. For comparation between groups Bonferroni will be used. If any confusion factor that not meet requirements to be analysed like a covaraible exist, ANCOVA will be used. When p\<0.0.5 statistical significant differences will be asumed.

Registry
clinicaltrials.gov
Start Date
January 9, 2020
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Gait

Time Frame: 10 minutes

10 meters Walking Test

Functionality

Time Frame: 10 minutes

FallSkip

Strength

Time Frame: 10 minutes

Load Cell

Secondary Outcomes

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

Study Sites (2)

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