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Effectiveness of Virtual Gait System Intervention in Motor Function in People With Incomplete Spinal Cord Injury.

Primary Purpose

Incomplete Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual Gait
Physical Exercise
Documental projection
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incomplete Spinal Cord Injury

Eligibility Criteria

16 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Facultat de Fisioterapia, Universitat de ValènciaRecruiting
  • Faculty of PhysiotherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Virtual Gait and Physical Exercise

Documental projection and Physical Exercise

Virtual Gait

Documental Projection

Arm Description

Outcomes

Primary Outcome Measures

Gait
10 meters Walking Test
Functionality
FallSkip
Strength
Load Cell

Secondary Outcome Measures

Spasticity
MyotonPRO
Neuropathic Pain
Brief Pain Inventory
Muscle Activation
EMG

Full Information

First Posted
December 1, 2020
Last Updated
February 28, 2022
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT04809987
Brief Title
Effectiveness of Virtual Gait System Intervention in Motor Function in People With Incomplete Spinal Cord Injury.
Official Title
Evaluation of Effectiveness of Virtual Gait System Intervention in Motor Function, Tone and Sensibility, in People With Incomplete Spinal Cord Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: Virtual Gait and Physical exercise. Documental projection and physical exercise. Virtual Gait. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incomplete Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Gait and Physical Exercise
Arm Type
Experimental
Arm Title
Documental projection and Physical Exercise
Arm Type
Sham Comparator
Arm Title
Virtual Gait
Arm Type
Experimental
Arm Title
Documental Projection
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Virtual Gait
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Intervention Description
Specific gait exercise was conducted.
Intervention Type
Other
Intervention Name(s)
Documental projection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gait
Description
10 meters Walking Test
Time Frame
10 minutes
Title
Functionality
Description
FallSkip
Time Frame
10 minutes
Title
Strength
Description
Load Cell
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Spasticity
Description
MyotonPRO
Time Frame
10 minutes
Title
Neuropathic Pain
Description
Brief Pain Inventory
Time Frame
10 minutes
Title
Muscle Activation
Description
EMG
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Facultat de Fisioterapia, Universitat de València
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SARA MOLLÀ CASANOVA, PhD student
Phone
655069680
Ext
0034
Email
sara.molla@uv.es
Facility Name
Faculty of Physiotherapy
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Serra Añó, Dr
Phone
657565150
Ext
51222
Email
pilar.serra@uv.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
17335974
Citation
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.
Results Reference
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Effectiveness of Virtual Gait System Intervention in Motor Function in People With Incomplete Spinal Cord Injury.

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