Virtual Gait System Intervention in Older People

NCT05273229 | Unknown

• 1 other identifier: 1675215UV
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Elderly People

Outcome Measures

Primary Outcomes (4)

• Walking distance (meters)

  2 min walk test

  2 minutes

• Functionality

  FallSkip

  10 minutes

• Muscular tone

  MyotonPRO

  10 minutes

• Lower extremity functionality

  Physical performance with Short Physical Performance Battery (SPPB). It is an assessment tool for evaluation of lower extremity functioning in older persons.

  10 minutes

Study Arms (4)

Virtual Gait and Physical Exercise

EXPERIMENTAL

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.

Other: Virtual Gait; Other: Physical exercise

Documental projection and Physical Exercise

SHAM COMPARATOR

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.

Other: Physical exercise; Other: Sham Virtual Gait

Virtual Gait

EXPERIMENTAL

only the virtual gait program will be carried out, detailed in Arm I.

Other: Virtual Gait

Virtual Gait Sham

SHAM COMPARATOR

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.

Other: Sham Virtual Gait

Interventions

Virtual Gait OTHER

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; Virtual Gait and Physical Exercise

Physical exercise OTHER

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; Virtual Gait and Physical Exercise

Sham Virtual Gait OTHER

only the placebo virtual gait.

Documental projection and Physical Exercise; Virtual Gait Sham

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy Recruiting Valencia, Spain, 46010

Valencia, 46010, Spain

RECRUITING

Related Publications (8)

• 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.

  PMID: 23894511 BACKGROUND

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

  PMID: 11347214 BACKGROUND

• 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.

  PMID: 31154013 BACKGROUND

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

  PMID: 3070327 BACKGROUND

• 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.

  PMID: 7954083 BACKGROUND

• 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.

  PMID: 20074212 BACKGROUND

• 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.

  PMID: 23290556 BACKGROUND

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

  PMID: 3210396 BACKGROUND

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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trail

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 10, 2022
• Study Start: January 1, 2022
• Primary Completion: September 10, 2022
• Study Completion: December 30, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)