- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05535088
Older Adults Virtual Reality
Immediate and Short-term Effects in Older Adults With the Use of Virtual Reality
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
Study Overview
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ignacio Lassaga, PT
- Phone Number: +5493413312612
- Email: ignacio_lassaga@hotmail.com
Study Contact Backup
- Name: Leonardo Intelangelo, MSc
- Phone Number: +5493414110506
- Email: lintelangelo@ugr.edu.ar
Study Locations
-
-
Santa Fe
-
Rosario, Santa Fe, Argentina, 2000
- Recruiting
- University of Gran Rosario
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
To have signed the informed consent.
Exclusion Criteria:
- Surgical history of the lower extremities
- Uncontrolled neurological, metabolic, cardiac or respiratory disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual reality
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in balance
Time Frame: At baseline and 2 weeks later
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Function
Time Frame: At baseline and 2 weeks later
|
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).
|
At baseline and 2 weeks later
|
Change in cybersikness
Time Frame: First day and 2 weeks later
|
Cybersickness was assessed by using the "Sickness Simulator Questionnaire" wich consists in 16 questions.
|
First day and 2 weeks later
|
Handgrip
Time Frame: Baseline
|
The handgrip was assessed using a Jamar dynamometer while the subjects were sited.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 18/20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aged
-
Samsung ElectronicsCompletedAged | Adults | Middle Age | Aged, 80 and OverKorea, Republic of
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingAged | Patient Safety | Aged, 80 and Over | Restraint, PhysicalSpain
-
University Hospital, ToulouseNot yet recruiting
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; Education University of Hong KongRecruiting
-
Abbott NutritionCompleted
-
Pontificia Universidad Catolica de ChileNot yet recruiting
-
National Yang Ming UniversityCompleted
-
University Hospital, ToulouseFondation pour la Recherche MédicaleCompleted
Clinical Trials on Virtual reality
-
Institut National de la Santé Et de la Recherche...Not yet recruitingSchizophrenia | Bipolar Disorder
-
Eskisehir Osmangazi UniversityNot yet recruiting
-
The University of Hong KongRecruiting
-
Universidad Rey Juan CarlosCompleted
-
University of PennsylvaniaNot yet recruitingEnd Stage Kidney Disease
-
National University of MalaysiaRecruitingPleural EffusionMalaysia
-
Stanford UniversityTerminatedConversion Disorder | Non-epileptic Seizures | Functional Neurological Disorder | Functional Movement Disorder | Psychogenic Movement DisorderUnited States
-
University of WashingtonNational Institutes of Health (NIH); University of Texas; National Institute...Completed
-
Centre Hospitalier Universitaire de Saint EtienneInstitut de Cancérologie de la Loire; Gustave Roussy, Cancer Campus, Grand... and other collaboratorsTerminated
-
Hacettepe UniversityRecruitingGonarthrosis; PrimaryTurkey