MedDataX Logo

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

NCT ID: NCT07231822

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoperosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Postmenopausal osteoporosis Virtual reality balance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized dontrolled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Conventional treatment

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Conventional treatment

Intervention Type OTHER

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.

Virtual reality treatment

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

İrem CANLI

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

İrem CANLI

Role: STUDY_DIRECTOR

Kirsehir Ahi Evran Universitesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kırşehir Ahi Evran University

Merkez, Kirşehi̇r, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

İrem CANLI, Ph.D.

Role: CONTACT

Phone: 05348377384

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

İrem CANLI

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23591230588?

Identifier Type: -

Identifier Source: org_study_id