Effect of Vırtual Realıty Glasses on Mıld Cognıtıve Impaırment in Elderly

December 13, 2024 updated by: Buket DAŞTAN, Karadeniz Technical University

Effect of Vırtual Realıty Glasses on Mıld Cognıtıve Impaırment in Elderly: A Randomızed Controlled Study

This study was conducted in a randomized controlled manner to investigate the effect of VR glasses on mild cognitive impairment in the elderly. The main questions the study aimed to answer are:

• Will VR improve mild cognitive impairment in the elderly? The researchers used a control group to compare the effect of VR on mild cognitive impairment.

Participants:

  • Before starting the study, the elderly were given the necessary forms and information.
  • The elderly were shown virtual reality videos with VR glasses 3 days a week for 4 weeks.
  • The control group did not watch any videos, and the post-test forms were filled out again for both groups at the end of 4 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The elderly population rate is rapidly increasing in the world and in our country. According to the World Health Organization (WHO) data, the elderly population aged 60 and over, which was 1 billion in 2019, is expected to increase to 1.4 billion in 2030 and 2.1 billion in 2050. In our country, the elderly population, which was 6 million in 2016, reached more than 8 million in 2023. (WHO 2021, TÜİK 2024). As life expectancy continues to increase, the number of elderly people who cannot live independently and need assistance due to cognitive decline is rapidly increasing worldwide (Díaz-Pérez &, Flórez-Lozano, 2018; Huang & Yang, 2022). Dementia is a collective name for a heterogeneous group of chronic neurodegenerative diseases characterized by progressive impairment of behavior and cognitive function (Aruanno & Garzotto, 2019; D'Cunha et al., 2019). Mild Cognitive Impairment (MCI) is an intermediate stage of cognitive change between normal aging and dementia; the distinction between MCI and dementia is determined by the severity of cognitive decline leading to functional impairment. MCI, also known as the "symptomatic predementia stage," causes mild deterioration in cognitive function without significant loss of independent functional abilities, social and occupational functioning in individuals (Kim et al., 2019). MCI is defined as a condition in which individuals experience memory loss greater than expected for their age but do not meet the criteria for dementia. This is a less severe degree of cognitive impairment compared to dementia and is classified as Mild Cognitive Impairment in the DSM-5. However, the capacity for independence in activities of daily living and instrumental activities of daily living is preserved, unlike diseases such as dementia (Oliveira et al., 2021). According to WHO, there are approximately 55 million people with dementia worldwide; this number is expected to increase to 75 million by 2030 and approximately 135 million by 2050 (WHO, 2023). However, individuals with MCI typically have a higher risk of dementia than individuals of the same age without MCI (Petersen et al., 2018; Aruanno & Garzotto, 2019; Kim et al., 2019). Although pharmacological interventions are recommended for the treatment of dementia types and MCI, polypharmacy in the elderly population can cause side effects. Therefore, new and effective non-pharmacological treatments are needed (Huang & Yang 2022). Updated practice guidelines have indicated that exercise and cognitive interventions may be beneficial for improving cognitive functions in patients with MCI (Kim et al., 2019). Participation in stimulation of mental activities in older ages may be a protective factor against cognitive decline and possibly reduce the risk of developing dementia (Manera et al., 2016). Virtual reality (VR) is a new technology used for the rehabilitation of cognitive and motor functions (Tieri et al., 2018). VR is defined as a real or imaginary three-dimensional environment of computer simulation that allows its users to experience the feeling of being in a different physical place (D'Cunha et al., 2019). VR is a new branch of computer technologies that has recently been proposed for use in the field of neuropsychology. VR is a high-level computer interface that includes real-time simulation and interactions through multiple sensory channels, based on various perception components of psychophysics, primarily visual, tactile and kinesthetic perceptual sensations. The use of VR systems offers the opportunity to simulate immersive and interactive real-life scenarios to create a sense of "being there" (Zhu et al., 2021). The use of VR systems for disease treatment has already been investigated in various fields such as brain injury, post-stroke intervention, and musculoskeletal recovery. VR environments have also been used for neuropsychological assessment and problems such as phobias, stress, anxiety, exercise, and memory problems (Luque-Moreno et al., 2021; Manera et al., 2016). It has been reported that the use of VR for both stimulation and relaxation in people with cognitive decline reduces stress. These studies suggest that virtual reality can be used as a promising tool in many therapeutic and rehabilitation areas in MCI and dementia and have attracted the attention of researchers (Manera et al., 2016). Therefore, this study aimed to determine the effect of VR intervention on MCI in elderly individuals.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Centre
      • Bayburt, Centre, Turkey, 69000
        • Bayburt State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The study included elderly individuals who were over the age of 65,
  • Diagnosed with MCI by a neurologist,
  • Having a Standard Mini-Mental Statement (MMSE) score between 18 and 23,
  • Having a Montreal Cognitive Assessment Scale (MOCA) score below 21,
  • Able to communicate verbally,
  • Agreeing to participate in the study.

Exclusion Criteria:

  • The study excluded those with a history of stroke or epilepsy,
  • Those with other suspected degenerative diseases or diagnosed severe psychiatric illnesses,
  • Those with head trauma, thyroid disorders or other medical abnormalities that could impair cognitive function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
No intervention was made to the elderly in this group.
Experimental: virtual reality group
Evaluated the effect of using virtual reality in elderly people with mild cognitive impairment.
Other: virtual reality intervention
Evaluated the effect of virtual reality use in elderly people with mild cognitive impairment compared to a control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Elderly Information Form
Time Frame: 4 week
The study includes questions to determine the age, gender, marital status, education level and chronic disease status of elderly individuals.
4 week
Mini-Mental State Examination
Time Frame: 4 week
The MMSE, which provides assessment of cognitive status, was developed by Folstein and colleagues in 1975 and is the most commonly used and easily administered test in dementia screening (Folstein, 1975). Its validity and reliability in the diagnosis of mild dementia for the Turkish population was performed by Güngen and colleagues (Güngen 2002). The mini mental test is grouped under five main headings: orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). The scale is evaluated out of a total of 30 points and has two different types for the educated and the uneducated. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment. A score between 18-23 points is considered mild dementia, 12-17 points is considered moderate dementia and 12 points below is considered severe dementia.
4 week
Montreal Cognitive Assessment Scale
Time Frame: 4 week
It is a screening scale developed specifically to evaluate the early stages of cognitive impairment. The scale evaluates attention and concentration, executive functions, memory, language, visual and spatial skills, abstract thinking, calculation and orientation functions. The test takes approximately 10 minutes. The visual structuring skills test is worth 5 points, the attention test is worth 6 points, the language (naming) test is worth 6 points, the abstract thinking test is worth 2 points, the delayed recall is worth 5 points and the orientation test is worth 6 points. Patients with 21 points and above out of 30 points are considered cognitively normal.
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Buket DAŞTAN, Ph.D, Karadeniz Tecnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCS15102024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I'll decide later

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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