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

NCT07231822 | Recruiting

• 1 other identifier: 23591230588?
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoperosis

Keywords

Postmenopausal osteoporosis; Virtual reality; balance

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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'.

  6 week

Secondary Outcomes (1)

• Quality of life in patients

  6 week

Study Arms (2)

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.

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.

Other: Conventional treatment; Other: Virtual reality treatment

Interventions

Conventional treatment 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.

Control Group; Virtual Reality Group

Virtual reality treatment 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.

Virtual Reality Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University

Center, Kirşehi̇r, 40100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• İrem CANLI

  Kirsehir Ahi Evran Universitesi

  STUDY DIRECTOR

Central Study Contacts

İrem CANLI, Ph.D.

CONTACT

05348377384; iremvalamur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomized dontrolled trial

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 17, 2025
• Study Start: November 20, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)