Older Adults Virtual Reality
Primary Purpose
Aged
Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Virtual reality
Sponsored by

About this trial
This is an interventional treatment trial for Aged
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
Sites / Locations
- University of Gran RosarioRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual reality
Arm Description
Virtual reality
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Function
The function was assessed by using the Short Physical Performance Battery. This is a series of 3 tests to assess lower extremity physical function: a 4-meter walk at usual pace, time to complete 5 unassisted chair stands, and 3 standing balance tests. The scores range from 0 (worst performance) to 12 (best performance).
Change in cybersikness
Cybersickness was assessed by using the "Sickness Simulator Questionnaire" wich consists in 16 questions.
Handgrip
The handgrip was assessed using a Jamar dynamometer while the subjects were sited.
Full Information
NCT ID
NCT05535088
First Posted
August 26, 2022
Last Updated
October 24, 2022
Sponsor
University of Gran Rosario
1. Study Identification
Unique Protocol Identification Number
NCT05535088
Brief Title
Older Adults Virtual Reality
Official Title
Immediate and Short-term Effects in Older Adults With the Use of Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gran Rosario
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aged
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The virtual reality will be applied by using a head mounted display. A minute of immersion was repited 6 times
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
Virtual reality
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in balance
Description
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.
Time Frame
At baseline and 2 weeks later
Secondary Outcome Measure Information:
Title
Function
Description
The function was assessed by using the Short Physical Performance Battery. This is a series of 3 tests to assess lower extremity physical function: a 4-meter walk at usual pace, time to complete 5 unassisted chair stands, and 3 standing balance tests. The scores range from 0 (worst performance) to 12 (best performance).
Time Frame
At baseline and 2 weeks later
Title
Change in cybersikness
Description
Cybersickness was assessed by using the "Sickness Simulator Questionnaire" wich consists in 16 questions.
Time Frame
First day and 2 weeks later
Title
Handgrip
Description
The handgrip was assessed using a Jamar dynamometer while the subjects were sited.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ignacio Lassaga, PT
Phone
+5493413312612
Email
ignacio_lassaga@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo Intelangelo, MSc
Phone
+5493414110506
Email
lintelangelo@ugr.edu.ar
Facility Information:
Facility Name
University of Gran Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Older Adults Virtual Reality
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