The Investigation of the Effectiveness of Virtual Reality Applications in Postmenopausal Osteoporosis Patients

February 25, 2026 updated by: İrem CANLI, Kirsehir Ahi Evran Universitesi

The Investigation of the Effectiveness of Virtual Reality Applications in Postmenopausal Osteoporosis Patients: A Randomized Controlled Trial

Osteoporosis is a progressive disease characterised by a decrease in bone mass, deterioration in bone microarchitecture, and increased fragility. Etiologically, it is divided into two types: primary (postmenopausal and senile) and secondary. Postmenopausal women are particularly at high risk; it is seen in more than 80% of women over the age of 50 and in almost all individuals over the age of 75. With menopause, bone mineral density decreases, which negatively affects neuromuscular functions, leading to balance disorders, decreased walking speed, and an increased risk of falls. Falls are the primary cause of osteoporotic fractures and result in functional loss, morbidity, mortality, and increased healthcare costs. Exercise is effective in reducing bone loss; in recent years, therapeutic virtual reality and exercise games (exergames) have come to the fore. However, the literature on the effectiveness of these applications in postmenopausal osteoporosis patients is limited. The aim of this study is to investigate the effects of virtual reality applications on balance, quality of life, and fall risk and to compare them with a control group.

Study Overview

Status

Status

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

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

According to the World Health Organisation's definition, osteoporosis is characterised as a progressive disease involving a decrease in bone mass, deterioration in bone microarchitecture, and an increase in bone fragility. Osteoporosis is classified into two types based on aetiological factors: primary and secondary. Primary osteoporosis is subdivided into postmenopausal and senile osteoporosis, while the aetiology of secondary osteoporosis is unclear. Although osteoporosis can affect people of all ages, postmenopausal women are a particularly high-risk group for developing osteoporosis. Osteoporosis is seen in more than 80% of women over the age of 50 and in almost all women and men over the age of 75. Postmenopausal osteoporosis is the most common form of the disease. With the onset of menopause, a progressive decrease in bone mineral density is observed. This decrease in bone mineral density negatively affects the neuromuscular system. Neuromuscular dysfunction in patients with postmenopausal osteoporosis leads to a decrease in the ability to stand, impaired dynamic balance, and an increased risk of falling due to a decrease in walking speed. Falls are a significant risk factor in the development of osteoporotic fractures. The occurrence of osteoporosis-related fractures can lead to a decrease in functional capacity, an increase in morbidity and mortality rates, and higher healthcare costs. Exercise has a positive effect on reducing bone mineral density loss. However, advances in technology have also increased the availability of video games for therapeutic purposes. Virtual reality or exergame applications that incorporate video games have become a new trend in response to the global challenges of ageing. However, there is limited literature investigating the effectiveness of virtual reality applications in postmenopausal osteoporosis patients. The aim of this study is to investigate the effectiveness of virtual reality applications on balance, quality of life, and fall risk in postmenopausal osteoporosis patients and to compare them with a control group.

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 (Estimated)

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.
50

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Kirşehi̇r
      • Center, Kirşehi̇r, Turkey (Türkiye), 40100
        • Recruiting
        • Kırsehir Ahi Evran University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Postmenopausal women aged 50-75 years
  • Individuals diagnosed with osteoporosis based on Dual-Energy X-ray Absorptiometry (DEXA) measurement (T-score ≤ -2.5)
  • Having been in menopause for at least 1 year
  • Being able to walk independently (without the use of assistive devices)
  • Volunteering to participate in the study and having provided informed consent
  • Having adequate cognitive function (e.g., Mini Mental Test ≥ 24)

Exclusion Criteria:

  • Secondary osteoporosis diagnosis (e.g. endocrine, metabolic or drug-induced causes)
  • History of lower limb fracture or surgical intervention within the last 6 months
  • Individuals with severe cardiovascular, neurological, or musculoskeletal disorders
  • Individuals with vestibular or visual impairments that may affect balance
  • Intolerance to virtual reality applications (e.g., dizziness, nausea, etc.)
  • Individuals who have participated in a regular physiotherapy or exercise programme within the last 3 months

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Experimental: Control Group
Traditional treatment will consist of posture exercises aimed at ensuring proper posture, strengthening exercises, balance exercises, patient education aimed at preventing falls and fractures, aerobic exercises, and interventions aimed at controlling acute and chronic pain and restoring independence in daily living activities.
Other: Conventional treatment
Traditional treatment will consist of posture exercises aimed at ensuring proper posture, strengthening exercises, balance exercises, patient education aimed at preventing falls and fractures, aerobic exercises, and interventions aimed at controlling acute and chronic pain and restoring independence in daily living activities.
Experimental: Virtual Reality Group
Virtual reality applications will consist of videos and video-based games (exergames). Should an application pose a risk to patients, the programme will be reviewed.
Other: Conventional treatment
Traditional treatment will consist of posture exercises aimed at ensuring proper posture, strengthening exercises, balance exercises, patient education aimed at preventing falls and fractures, aerobic exercises, and interventions aimed at controlling acute and chronic pain and restoring independence in daily living activities.
Other: Virtual reality treatment
Virtual reality applications will consist of videos and video-based games (exergames). Should an application pose a risk to patients, the programme will be reviewed.

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
Balance Level
Time Frame: 6 week
Individual balance level assessments will be conducted using the Biodex balance device, which is reported to be valid and reliable for balance measurements, on both static and dynamic surfaces. The BDS consists of a mobile balance platform that provides a 360° range of motion and up to 20° surface inclination. The platform moves around the anteroposterior and mediolateral axes. The device measures the deviation of the centre of pressure in static conditions and calculates the degree of axis inclination in dynamic conditions. The difficulty level of the test is adjusted by changing the range of motion of the mobile platform and the surface inclination of the platform. Minimum stability on the platform can be set to 0 and maximum stability to 12. The test evaluates the patient's ability to maintain their centre of balance. The Biodex Balance System measures how far the patient's position deviates from the centre and reports the average deviation as a stability index. If the patient is
6 week
Cognitive State
Time Frame: 6 week
The mini mental test, consisting of a total of 11 questions under five main headings: orientation, memory, attention and calculation, recall, and language, will be used to compare patients' cognitive status. This test is scored between 0 and 30. The assessment indicates that a score of 24-30 indicates normal cognitive function, 18-23 indicates mild cognitive impairment, and 18 points and below indicates that cognitive function is seriously impaired. A score of 24-30 indicates normal cognitive function, 18-23 indicates mild cognitive impairment, and 18 or below indicates that cognitive function is seriously impaired.
6 week
Risk of Falling
Time Frame: 6 week
Individuals' risk of falling will be assessed using the BioDex balance device. The test measures the patient's postural sway velocity to predict the risk of falling. Speed is the individual's sway speed while maintaining balance. High scores suggest further evaluation for lower extremity strength, proprioception, and vestibular or visual deficits. In the fall risk test, individuals will stand upright with arms free on the BDS for 45 seconds with eyes open, then rest for 30 seconds. They will then wait for another 45 seconds with their eyes closed in the same upright standing position with arms free. The fall risk assessment results will be recorded as 'eyes open stance, eyes closed stance, and composite score'.
6 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life in patients
Time Frame: 6 week
The QUALEFFO-41 quality of life questionnaire, which assesses osteoporosis-related quality of life and has been validated and proven reliable in Turkish; A; pain (5 questions), B; physical function/daily living activities (4 questions), C; physical function/household chores (5 questions), D; physical function/mobility (8 questions), E; social activities (7 questions), F; general health perception (3 questions), G; mental function (9 questions). Responses to the questions in the QUALEFFO-41 scale will be scored on a scale from 1 (healthy) to 5 (unhealthy).
6 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.
Kirsehir Ahi Evran Universitesi

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.
  • Study Director: İrem CANLI, Kirsehir Ahi Evran Universitesi

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.
November 20, 2025

Primary Completion (Estimated)

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.
March 1, 2026

Study Completion (Estimated)

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.
March 1, 2026

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).
November 14, 2025

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.
November 14, 2025

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.
November 17, 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.
February 27, 2026

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.
February 25, 2026

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.
February 1, 2026

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.
  • 23591230588?

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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