Incomplete Spinal Cord InjuryNCT04809987
Effectiveness of Virtual Gait System Intervention in Motor Function in People With Incomplete Spinal Cord Injury.
A study testing Virtual Gait, Physical Exercise and Documental projection in people with Incomplete Spinal Cord Injury, run by University of Valencia at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Incomplete Spinal Cord Injury
- What is being tested?
- Virtual Gait, Physical Exercise and Documental projection
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Jan 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Incomplete spinal cord injury (ASIA C,D or E).
- Mini-Mental State Examination >23 points.
Who cannot join
- Lower limbs traumathic pathology.
- Other nervous system alterations.
- Vestibular diseases.
- Other diseases.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Faculty of Physiotherapy
Valencia, Spain, 46010
Facultat de Fisioterapia, Universitat de València
Valencia, Valencia, 46010
About this study
Official title: Evaluation of Effectiveness of Virtual Gait System Intervention in Motor Function, Tone and Sensibility, in People With Incomplete Spinal Cord Injury.
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.
Read more
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.
Read the 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.
- Conditions
- Incomplete Spinal Cord Injury
- Being tested
- Virtual Gait, Physical Exercise, Documental projection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual GaitOther
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 ExerciseOther
Specific gait exercise was conducted.
Documental projectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Gait and Physical Exercise | Experimental | Not described Receives: Other: Virtual Gait; Other: Physical Exercise |
| Documental projection and Physical Exercise | Sham comparator | Not described Receives: Other: Physical Exercise; Other: Documental projection |
| Virtual Gait | Experimental | Not described Receives: Other: Virtual Gait |
| Documental Projection | Sham comparator | Not described Receives: Other: Documental projection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait
10 meters Walking Test
Measured: 10 minutes
Functionality
FallSkip
Measured: 10 minutes
Strength
Load Cell
Measured: 10 minutes
Secondary outcomes (3)
Spasticity
MyotonPRO
Measured: 10 minutes
Neuropathic Pain
Brief Pain Inventory
Measured: 10 minutes
Muscle Activation
EMG
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start30 Jan 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Incomplete Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pilar Serra Añó, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809987
- Sponsor's protocol ID
- 09102019
- Status last verified
- Sep 2024
- First submitted
- 1 Dec 2020
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 17335974Molla-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.
PubMed 39856165
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of Virtual Gait System Intervention in Motor Function, Tone and Sensibility, in People With Incomplete Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT04809987
- Acronym / sponsor ID
- 09102019
- Conditions
- Incomplete Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Incomplete spinal cord injury (ASIA C,D or E).
- Mini-Mental State Examination >23 points.
Key exclusion criteria (4 listed)
- Lower limbs traumathic pathology.
- Other nervous system alterations.
- Vestibular diseases.
- Other diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual GaitThe 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. | Other | Virtual Gait, Virtual Gait and Physical Exercise |
| Physical ExerciseSpecific gait exercise was conducted. | Other | Documental projection and Physical Exercise, Virtual Gait and Physical Exercise |
| Documental projectionThe 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. | Other | Documental Projection, Documental projection and Physical Exercise |
Primary outcome
Gait
Time frame: 10 minutes
10 meters Walking Test
Functionality
Time frame: 10 minutes
FallSkip
Strength
Time frame: 10 minutes
Load Cell
3 secondary outcomes
Spasticity
Time frame: 10 minutes
Neuropathic Pain
Time frame: 10 minutes
Muscle Activation
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 17335974Moseley 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.
- Derived from this study: PubMed 39856165Molla-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Gait, Physical Exercise and Documental projection in people with Incomplete Spinal Cord Injury, run by University of Valencia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04809987, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.