An observational study in Postmenopausal Osteopenia, Quality of Life and Validity, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to female participants aged 48 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Riphah International University · Observational
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.
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 80 is below the median of 174 across 446 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Postmenopausal women diagnosed with Osteoporosis and Osteopenia , clinically stable, between age 48-70 years and able to read and complete the Urdu version of ECOS-16 Questionnaire. Women having any condition mentioned in exclusion criteria will not be included in the study.
Exclusion Criteria:
ECOS-16 Quality of Life Questionnaire
ECOS-16 evaluates the quality of life in postmenopausal women with osteoporosis. It is a brief, straightforward, self-administered questionnaire containing 16 easy-to-score items. 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. Its translation is to be done in the local languages of Pakistan through a rigorous and approved process.
Time frame: 6 Months
Reliability of Urdu translated version
To determine reliability of cross-culturally adapted and the Urdu translated version of ECOS-16 in postmenopausal women with Osteoporosis/Osteopenia. Reliability or reproducibility refers to the ability of a measure to produce the same results when administered at two or more intervals between different visits of the patient.
Time frame: 6 Months
Validity of Urdu Translated version
To determine validity of cross-culturally adapted and the Urdu translated version of ECOS-16 in postmenopausal women with Osteoporosis/Osteopenia. Validity is how accurate the tool measures an item it is supposed to. Thus these both are to be measured through various parameters to validate the translated version as appropriate and applicable.
Time frame: 6 Months
Plan to share: No
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Riphah International University