Effectiveness of Virtual Gait System Intervention in Motor Function in People with Incomplete Spinal Cord Injury.
NCT ID: NCT04809987
Last Updated: 2024-09-19
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
38 participants
INTERVENTIONAL
2021-01-30
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Virtual Gait and Physical Exercise
Virtual Gait
The subject will be stand up with a standing opposite a mirror (from the waist up) and a screen (from the waist down) where a video of treadmill gait of a person will be projected.
Physical Exercise
Specific gait exercise was conducted.
Documental projection and Physical Exercise
Physical Exercise
Specific gait exercise was conducted.
Documental projection
The subject will be stand up with a standing opposite a mirror (from the waist up) and a screen (from the waist down) where video without any type of animal or human movement was showed.
Virtual Gait
Virtual Gait
The subject will be stand up with a standing opposite a mirror (from the waist up) and a screen (from the waist down) where a video of treadmill gait of a person will be projected.
Documental Projection
Documental projection
The subject will be stand up with a standing opposite a mirror (from the waist up) and a screen (from the waist down) where video without any type of animal or human movement was showed.
Interventions
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Virtual Gait
The subject will be stand up with a standing opposite a mirror (from the waist up) and a screen (from the waist down) where a video of treadmill gait of a person will be projected.
Physical Exercise
Specific gait exercise was conducted.
Documental projection
The subject will be stand up with a standing opposite a mirror (from the waist up) and a screen (from the waist down) where video without any type of animal or human movement was showed.
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination \>23 points.
Exclusion Criteria
* Other nervous system alterations.
* Vestibular diseases.
* Other diseases.
16 Years
99 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Responsible Party
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Pilar Serra Añó
Chaired Full Professor
Locations
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Faculty of Physiotherapy
Valencia, Spain, Spain
Facultat de Fisioterapia, Universitat de València
Valencia, Valencia, Spain
Countries
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References
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Moseley LG. Using visual illusion to reduce at-level neuropathic pain in paraplegia. Pain. 2007 Aug;130(3):294-298. doi: 10.1016/j.pain.2007.01.007. Epub 2007 Mar 1.
Molla-Casanova S, Munoz-Gomez E, Moreno-Segura N, Ingles M, Aguilar-Rodriguez M, Sempere-Rubio N, Serra-Ano P. Effect of a virtual walking and exercise-based intervention on muscle strength and activation in people with incomplete spinal cord injury. Sci Rep. 2025 Jan 24;15(1):3144. doi: 10.1038/s41598-025-86845-8.
Other Identifiers
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09102019
Identifier Type: -
Identifier Source: org_study_id
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