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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04873960
Other study ID # REC/Lhr/21/1102/A Saima Riaz
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date May 25, 2022

Study information

Verified date June 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


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Study Design


Locations

Country Name City State
Pakistan Saima Riaz Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 Months
Secondary 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. 6 Months
Secondary 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. 6 Months
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