NCT05535088

Brief Summary

In the older adult population, over the years, progressive changes are generated on the different functions and systems of the human body. The musculoskeletal system is not exempt from this process, with the loss of muscle associated with aging being one of the main problems for the older adult population. These alterations bring with them a decrease in muscle strength, along with a loss of functional capacity. Among all the consequences that these deficits can generate, there are: alterations in gait, difficulties in daily transfers, alterations in balance, among others. These changes develop as a consequence an increased risk of falling, these being one of the main causes of morbidity and mortality in the elderly. As technological development advances, new devices are being created that allow new forms of training our senses and abilities. Since its conception, in the late 1980s, virtual reality has been an area of growing possibilities. Butler and Willet define virtual reality as a technology that allows the user to interact directly with a computer-simulated environment. This tool is gaining more and more interest in the motor rehabilitation of multiple pathologies and also as an option for stability training in older patients. The aim of this study is to evaluate changes in stability after a 2 weeks protocol of virtual reality

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2025

Completed
Last Updated

November 17, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

August 26, 2022

Last Update Submit

November 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in balance

    Balance will be assessed using a balance tracking system balance plate (Balance Tracking Systems, San Diego, CA). Participants stood on the plate for six testing trials. The first three measurement were made with bipedal stance and eyes closed, for about 30 seconds. The next three assessments were made with monopodal support on the right foot and the las 3 measurements were made with monopodal support on the left foot each monopodal repetition last 15 seconds.

    At baseline and 2 weeks later

Secondary Outcomes (3)

  • Function

    At baseline and 2 weeks later

  • Change in cybersikness

    First day and 2 weeks later

  • Handgrip

    Baseline

Study Arms (1)

Virtual reality

EXPERIMENTAL

Virtual reality

Device: Virtual reality

Interventions

Virtual reality consists for about a minute and a half 6 times per session. During the first and the second session, subjects will experiment virtual reality while sited. Moreover, during the third and the fourth session subjects will be standing with a side by side stand. During the last two experimental sessions subjetcts will be standing with a semi tandem stand.

Virtual reality

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To have signed the informed consent.

You may not qualify if:

  • Surgical history of the lower extremities
  • Uncontrolled neurological, metabolic, cardiac or respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gran Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The virtual reality will be applied by using a head mounted display. A minute of immersion was repited 6 times
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant researcher

Study Record Dates

First Submitted

August 26, 2022

First Posted

September 10, 2022

Study Start

October 20, 2022

Primary Completion

November 22, 2024

Study Completion

September 9, 2025

Last Updated

November 17, 2025

Record last verified: 2025-09

Locations