OsteoperosisNCT07231822
The Investigation of the Effectiveness of Virtual Reality Applications in Postmenopausal Osteoporosis Patients
A study testing Conventional treatment and Virtual reality treatment in people with Osteoperosis, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoperosis
- What is being tested?
- Conventional treatment and Virtual reality treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 1 Mar 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırşehir Ahi Evran University
Center, Kirşehi̇r, 40100
İrem CANLI, 05348377384, iremvalamur@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoperosis
- Being tested
- Conventional treatment, Virtual reality treatment
- Keywords
- Postmenopausal osteoporosis, Virtual reality, balance
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatmentOther
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | 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. Receives: Other: Conventional treatment |
| Virtual Reality Group | Experimental | 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. Receives: Other: Conventional treatment; Other: Virtual reality treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Level
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
Measured: 6 week
Cognitive State
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.
Measured: 6 week
Risk of Falling
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'.
Measured: 6 week
Secondary outcomes (1)
Quality of life in patients
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).
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start20 Nov 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoperosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized dontrolled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İrem CANLI, Kirsehir Ahi Evran Universitesi
- Investigators
- İrem CANLI, Study director, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231822
- Sponsor's protocol ID
- 23591230588?
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No