Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT04873960
Brief Summary:
Osteopenia is a clinical term to define the declined Bone Mineral Density (BMD) as per the normal reference values but not low enough to meet osteoporotic diagnostic criteria. A Dual-energy x-ray absorptiometry (DXA) bone scan is used to diagnose decreased BMD. Osteopenia is, as described by the World Health Organization (WHO), a score ranging from -1 to -2.5, whereas Osteoporosis is diagnosed with values less than - 2.5. The risk of a decrease in BMD doubles as a woman goes into Menopause.
The objective of this study will be to determine the effects of Kinect-based virtual reality training on BMD, fracture risk, physical function and Quality of life in postmenopausal women with Osteopenia. The aim of the present study is to translate the ECOS-16 Questionnaire into Urdu Language along with validation of the translated versions by evaluating its validity and reliability in the Postmenopausal women of Pakistan with Osteopenia or Osteoporosis and understanding Urdu Language. No such study has been previously conducted in the Pakistan region which translates the specific questionnaire and follows the proper cross-culture adaptation protocol.
Detailed Description:
ECOS-16 was developed to evaluate the quality of life in postmenopausal women with osteoporosis. It is a brief, straightforward, self-administered questionnaire containing 16 easy-to-score items, 4 of which are taken from OQLQ and the remaining 12 taken from the Questionnaire of the QUALEFFO-41 . The 16 items are further divided into four subscales: pain (5 items), physical functioning (5 items), illness-related fear (2 items), and psychosocial functioning (4 items). Each question related to these items has five response options, ranging from 1 to 5, where 5 represents the worst quality of life score. ECOS-16 provides both subscale domain scores and an overall score. ECOS-16 questionnaire, originally developed in English, has been translated into many languages to assess for its validity and reliability ever since, but Urdu version is not developed or tested. Previous studies have shown that the translation of the scale would end up giving a standard measure to be utilized in clinical practices and research studies while sanctioning clinicians and specialists to share information and have an insight into patient's health-related concerns of Osteoporosis. The reliability and validity of the ECOS-16 have been well documented by the developers of the instrument Thus, it is imperative to translate this questionnaire into psychometrically tested Urdu version. This may promote an easy understanding of the local population in Pakistan where the Urdu language is spoken and will provide a valid measure of Quality of life to be clinically utilized by practitioners and researchers across the country.
Study:
NCT04873960
Study Brief:
Protocol Section:
NCT04873960