Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-01-01
2022-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficiency of New Technologies in the Aging Process
NCT04615897
New Technological Pathway for Gait Rehabilitation
NCT06859229
Effects of Training in a Virtual Environment in Healthy Elderly
NCT01741402
The Effects of Cognitive-motor Training in Healthy Older Adults
NCT04786132
Effects of a Multicomponent Training in Pre-frail Elderly
NCT03110419
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Virtual Gait and Physical Exercise
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.
Virtual Gait
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 exercise
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.
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.
Physical exercise
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 Gait
only the placebo virtual gait.
Virtual Gait
only the virtual gait program will be carried out, detailed in Arm I.
Virtual Gait
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.
Virtual Gait Sham
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.
Sham Virtual Gait
only the placebo virtual gait.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual Gait
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 exercise
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 Gait
only the placebo virtual gait.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to walk with or without aids
Exclusion Criteria
* Other nervous system alterations.
* Vestibular diseases.
* Other diseases.
60 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Valencia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Physiotherapy Recruiting Valencia, Spain, 46010
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Sudarsky L. Gait disorders: prevalence, morbidity, and etiology. Adv Neurol. 2001;87:111-7. No abstract available.
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.
Aitkens M. A legacy of surgeons. Minn Med. 1988 Oct;71(10):592-6. No abstract available.
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.
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.
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.
Onishi H. [The current status and future of prosthetic joint replacement]. Kango Gijutsu. 1988 Oct;34(13):1566-71. No abstract available. Japanese.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1675215UV
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.