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Elderly PeopleNCT05273229

Virtual Gait System Intervention in Older People

A study testing Virtual Gait and Physical exercise in people with Elderly People, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Previous studies have shown that the neuroplasticity of the residual corticospinal fibers, the motor cortex and the spinal neurons plays an important role in the spontaneous functional recovery of people with neurological or musculoskeletal pathology. Read more about this study

Who is it for?
Ages 60 to 99 years
Conditions the study is for
Elderly People
What is being tested?
Virtual Gait and Physical exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteSpain
Study dates
1 Jan 2022to 30 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 60 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Mini-Mental State Examination >23 points.
  • Ability to walk with or without aids

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Faculty of Physiotherapy Recruiting Valencia, Spain, 46010

    Valencia, Valencia, 46010

Other trials in Spain

About this study

Official title: Effectiveness of Virtual Gait System Intervention in Motor Function in Older People.

Previous studies have shown that the neuroplasticity of the residual corticospinal fibers, the motor cortex and the spinal neurons plays an important role in the spontaneous functional recovery of people with neurological or musculoskeletal pathology. However, it is also possible to stimulate the neuroplasticity mechanisms of these structures through techniques aimed at rehabilitating different deficits (for example, motor function or sensitivity). In general, intervention programs are usually carried out, in most cases, using low-cost strategies such as therapeutic physical exercise programs.

The objective of this study is to analyze the effectiveness of visual illusion therapies in combination with conventional exercises on the symptoms and signs related to elderly people.

Read more

The study will include the realization of three measurements that will be carried out one day before starting the program, one day after finishing it, and one month later (follow-up).

The clinical assessment will be composed of the study of the following variables: Motor function and motor skills, Upper limb isometric force, Muscle activation, Muscle tone, Quality of life, Functionality. All interventions will last eight weeks and will be planned according to the availability of volunteers. In each session, it will be recorded if any type of adverse effect occurs. There will be four types of interventions: i. Visual Illusion (IV) and therapeutic exercise program (PE), ii.placebo and PE, iii. IV, iv. IV placebo.

Read the detailed description

The prevalence of gait and balance disorders increases by 10% between 60 and 69 years of age, reaching 60% in people over 80 years of age or 82% in people over 85 years of age. These disorders are also characteristic of populations with different neurological or musculoskeletal conditions. This supposes a profound psychological and socioeconomic impact on the affected person's life, in addition to the implicit physical impact.

After an injury (whether acquired or due to deterioration due to aging), there is a spontaneous functional recovery that can have different paths depending on the characteristics of the injury and the person. Previous studies have shown that the neuroplasticity of residual corticospinal fibers, motor cortex and spinal neurons plays an important role in the spontaneous functional recovery of people with neurological or musculoskeletal pathology, as well as in the reorganization of the spinal system. motor skills of the elderly. However, it is also possible to stimulate the neuroplasticity mechanisms of these structures through techniques aimed at rehabilitating different deficits (for example, motor function or sensitivity). In general, intervention programs aimed at improving neuroplasticity are usually carried out, in most cases, using low-cost strategies such as therapeutic physical exercise programs.

This nerve reorganization and recovery can also be influenced by the activity of mirror neurons, which are found in motor and premotor areas and also in other cortical and subcortical areas; and report activation when they observe an action with a specific purpose. The activity of these neurons has been studied in different populations with Central Nervous System (CNS) involvement, such as strokes, head injuries, Parkinson's or Alzheimer's. For its study, experimental investigations have been carried out applying different interventions that modify the activity of mirror neurons, such as mirror therapy, virtual reality therapies, Action-Observation therapies or visual illusion. In general, promising results have been obtained in all these populations, except in the case of advanced-stage Alzheimer's disease.

Visual illusion therapies have been used in different populations, such as spinal cord injury, with promising results. However, this type of therapy has not been studied in other populations with different neurological or musculoskeletal conditions, as well as in the elderly population.

The main objective of this study is to evaluate the efficacy of a virtual walking treatment (visual illusion) comparing it with interventions combined with specific physical exercise of walking in elderly people, on the functional capacity of this population.

Taking all of the above into account, the main objective of this study is to evaluate the efficacy of a virtual gait treatment (visual illusion) compared to interventions combined with specific physical gait exercise in people with disabilities or older people, on functional capacity of these populations. Specifically, it is intended to know the impact of virtual gait therapy on:

  • The actual gait, both speed and resistance.
  • Functionality in mobility activities and postural control.
  • Isometric strength of lower extremities.
  • Muscular tone, stiffness and elasticity of the leg muscles.
  • Neuropathic pain and sensitivity.

Therefore, this study aims to provide knowledge to the scientific community on how the mechanisms of neuroplasticity and specifically mirror neurons can influence the rehabilitation of people with disabilities and the elderly and, in addition, to propose a specific treatment methodology for the rehabilitation of the march in this type of population.

The recruitment and execution of the interventions will be carried out in a room set up within the Faculty of Physiotherapy of the University of Valencia. All procedures will be carried out under the principles of the Declaration of Helsinki (World Medical Association) and will be approved by the ethics committee of the University of Valencia. In addition, all participants will be asked to sign an informed consent that will include all the sections required by this committee.

A minimum of 20 participants per group is established, establishing a power of 80%, an ability to detect a small effect size (Cohen's d = 0.3) for the main variable resistance measured with the 2min Walking Test and a probability of type error. I of 0.05, resulting in a total of 80 participants. In order to minimize possible losses, 25% more patients per group will be added, so 100 people will participate in the study.

The study will contemplate the realization of three measurements that will be carried out one day before starting the program, one day after finishing it, and 1 month later. These will be carried out by team members who are blind to the assignment of the interventions.

In the first evaluation, anthropometric and demographic data will be collected (i.e. height, weight, age, educational level, possible comorbidities, etc.) with the aim of controlling, if necessary, these confounding variables.

The data analysis will be carried out using the SPSS statistical program (version 26). The normality of the sample will be analyzed using the Shapiro Wilk test and homoscedasticity using the Levene test. For the comparison between groups, a mixed factorial ANOVA will be used, and for the comparison between pairs of groups the Bonferroni correction will be used. In the event that there may be a confounding factor that meets the requirements to be analyzed as a covariate, an ANCOVA will be used. Statistically significant differences will be assumed when the p-value is less than 0.05.

All interventions will last eight weeks and will be planned according to the availability of volunteers. In each session, it will be recorded if any type of adverse effect occurs.

There will be four types of interventions resulting of a combination of:

Visual Illusion (IV): the patient will be placed in a standing position (with a help system designed ad-hoc) in front of a mirror (from the waist up) and a screen (from the waist down) where a video of legs walking will be projected. a treadmill and overcoming obstacles.. This program will last 10 minutes.

Therapeutic exercise program (PE): Physical exercise program for the lower extremities will be carried out.

Conditions
Elderly People
Being tested
Virtual Gait, Physical exercise, Sham Virtual Gait

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual GaitOther

    Virtual Gait: the patient will be placed in a standing position (with an ad-hoc designed help system) in front of a mirror (from the waist up) and a screen (from the waist down) where a video of legs walking on a treadmill will be projected and overcoming obstacles. Projected legs will be customized based on height, using the tibia length method.

  • Physical exerciseOther

    PE: it will be divided into two parts: in the first one, a gait technique training will be carried out and, in the second, a leg strength training, for 30 min. Exercises:

    • Coordination exercises: normal and lateral parallel walking and walking with obstacles.
    • Functional exercises such as climbing stairs, etc.
    • Lower limb strength exercises. Strength exercises will be prescribed according to the guidelines of the American College of Sports Medicine (ACSM). Progression will be customized based on individual abilities.
  • Sham Virtual GaitOther

    only the placebo virtual gait.

Study groups in NCT05273229
Study groupRoleWhat they receive
Virtual Gait and Physical ExerciseExperimentalVirtual 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.
Receives: Other: Virtual Gait; Other: Physical exercise
Documental projection and Physical ExerciseSham comparatorPhysical 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.
Receives: Other: Physical exercise; Other: Sham Virtual Gait
Virtual GaitExperimentalonly the virtual gait program will be carried out, detailed in Arm I.
Receives: Other: Virtual Gait
Virtual Gait ShamSham comparatorDocumental 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.
Receives: Other: Sham Virtual Gait

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Walking Distance (Meters)

    Number of meters capable of traveling in 2 minutes.

    Measured: After intervention, 5 minutes

  2. Functionality, Timed Up and GO

    FallSkip is an inertial sensor embedded in the Android device FallSkip® system (Biomechanical Institute of Valencia, València, Spain) was used according to the protocol previously developed and validated by our group . The device was fixed at the height of L4-L5, approximately. The main outcomes is total time to complete the test, in seconds.

    Measured: Before and after intervention, 10 minutes

  3. Muscular Tone

    The myometer MyotonPRO® (Myoton AS, Tallinn, Estonia) was used to explore the impact on the dominant lower-limb muscle tone. The reliability of MyotonPRO® has been demonstrated for the evaluation of muscle properties [36-38] and the measurement procedures were performed as described previously. In this study, lower-limb muscles (i.e., tibialis anterior, rectus femoris of the quadriceps, gluteus major, biceps femoris of the hamstrings, and gastrocnemius lateralis muscles) were assessed.

    First of all, a line was drawn between the two anatomical landmarks of the given muscle, following the manufacturer's recommendations. Then, the assessment point (centre of the muscle belly) was identified on that line, at the largest cross-section of the muscle belly, and those points were marked with a pen. The MAIN outcome used were Natural Oscillation Frequency (Hz)

    Measured: Before and after intervention, 10 minutes

  4. Lower Extremity Functionality

    Five Time Sit to Stand

    Measured: Before, and after intervention, 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2022
  2. Study start1 Jan 2022
  3. Primary completion10 Sep 2022
  4. Study completion30 Sep 2023

Resources

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
Model description
Randomized Clinical Trail
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273229
Sponsor's protocol ID
1675215UV
Status last verified
Sep 2026
First submitted
1 Feb 2022
Last updated
14 Oct 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Mahlknecht P, Kiechl S, Bloem BR, Willeit J, Scherfler C, Gasperi A, Rungger G, Poewe W, Seppi K. Prevalence and burden of gait disorders in elderly men and women aged 60-97 years: a population-based study. PLoS One. 2013 Jul 24;8(7):e69627. doi: 10.1371/journal.pone.0069627. Print 2013.

    PubMed 23894511
  • Sudarsky L. Gait disorders: prevalence, morbidity, and etiology. Adv Neurol. 2001;87:111-7. No abstract available.

    PubMed 11347214
  • Nguyen L, Murphy K, Andrews G. Cognitive and neural plasticity in old age: A systematic review of evidence from executive functions cognitive training. Ageing Res Rev. 2019 Aug;53:100912. doi: 10.1016/j.arr.2019.100912. Epub 2019 May 30.

    PubMed 31154013
  • Aitkens M. A legacy of surgeons. Minn Med. 1988 Oct;71(10):592-6. No abstract available.

    PubMed 3070327
  • Jeannerod M. The hand and the object: the role of posterior parietal cortex in forming motor representations. Can J Physiol Pharmacol. 1994 May;72(5):535-41. doi: 10.1139/y94-077.

    PubMed 7954083
  • Dushanova J, Donoghue J. Neurons in primary motor cortex engaged during action observation. Eur J Neurosci. 2010 Jan;31(2):386-98. doi: 10.1111/j.1460-9568.2009.07067.x. Epub 2010 Jan 13.

    PubMed 20074212
  • Vigneswaran G, Philipp R, Lemon RN, Kraskov A. M1 corticospinal mirror neurons and their role in movement suppression during action observation. Curr Biol. 2013 Feb 4;23(3):236-43. doi: 10.1016/j.cub.2012.12.006. Epub 2013 Jan 3.

    PubMed 23290556
  • Onishi H. [The current status and future of prosthetic joint replacement]. Kango Gijutsu. 1988 Oct;34(13):1566-71. No abstract available. Japanese.

    PubMed 3210396

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Gait and Physical exercise in people with Elderly People, run by University of Valencia at 1 site 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 14 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Walking Distance (Meters) (time frame: After intervention, 5 minutes). The study lists 4 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 NCT05273229, which also lists 8 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 14 Oct 2026.

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