Clinical trial NCT05535088: Older Adults Virtual Reality
Official title: Immediate and Short-term Effects in Older Adults With the Use of Virtual Reality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aged
Lead sponsor: University of Gran Rosario
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 35
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The virtual reality will be applied by using a head mounted display. A minute of immersion was repited 6 times
Primary purpose: TREATMENT

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

Detailed description: This is a quasi-experimental study with a sample of 35 volunteers. Patients of both genders and over 60 years old will be potential candidates for participating in the study. Volunteers will be invited to participate in the study through social networks and e-mail.

The study will be conducted in 6 experimental sessions on different days and 2 assessment days. During assessment sessions several measurements will be performed, including: balance (will be assessed using a balance tracking system balance plate) function (will be assessed by using the Short Physical Performance Battery) and cybersikness (will be assessed using the Sickness Simulator Questionnaire).

The experimental sessions consist in virtual reality immersion for about 1 minute 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 subjects will be standing with a semi tandem stand.

The one-tailed a priori sample size calculation used the effect size calculated to detect 2.39 cm2 of difference in the displacement area parameter. The sample size for the study was calculated as α set at 5% and the expected power (1-β) at 95%. The analysis returned a minimal sample of 35 participants. With an actual power of 0.95. The G-Power (v. 3.1.9.7, Franz Faul, University Kiel, Germany).

Eligibility criteria: Inclusion Criteria:

To have signed the informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in balance
timeFrame: At baseline and 2 weeks later
Secondary outcomes:
measure: Function
timeFrame: At baseline and 2 weeks later
measure: Change in cybersikness
timeFrame: First day and 2 weeks later
measure: Handgrip
timeFrame: Baseline
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: University of Gran Rosario
state: Santa Fe
Study officials:
References: