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

NCT04809987 | Active Not Recruiting

• 1 other identifier: 09102019
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Incomplete Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

• Gait

  10 meters Walking Test

  10 minutes

• Functionality

  FallSkip

  10 minutes

• Strength

  Load Cell

  10 minutes

Secondary Outcomes (3)

• Spasticity

  10 minutes

• Neuropathic Pain

  10 minutes

• Muscle Activation

  10 minutes

Study Arms (4)

Virtual Gait and Physical Exercise

EXPERIMENTAL

Other: Virtual Gait; Other: Physical Exercise

Documental projection and Physical Exercise

SHAM COMPARATOR

Other: Physical Exercise; Other: Documental projection

Virtual Gait

EXPERIMENTAL

Other: Virtual Gait

Documental Projection

SHAM COMPARATOR

Other: Documental projection

Interventions

Virtual Gait OTHER

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.

Virtual Gait; Virtual Gait and Physical Exercise

Physical Exercise OTHER

Specific gait exercise was conducted.

Documental projection and Physical Exercise; Virtual Gait and Physical Exercise

Documental projection OTHER

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.

Documental Projection; Documental projection and Physical Exercise

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (2)

Faculty of Physiotherapy

Valencia, Spain, 46010, Spain

Location

Facultat de Fisioterapia, Universitat de València

Valencia, Valencia, 46010, Spain

Location

Related Publications (2)

• 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.

  PMID: 17335974 BACKGROUND

• 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.

  PMID: 39856165 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chaired Full Professor

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: March 22, 2021
• Study Start: January 30, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)