Clinical trial NCT04873960: Translation and Cross -Cultural Validation of ECOS-16 Questionnaire in Urdu Language
Official title: Translation of ECOS-16 Questionnaire in Urdu Language; Validity and Reliability Analysis in Postmenopausal Women With Osteopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Osteopenia
Quality of Life
Validity
Reliability
Postmenopausal Osteoporosis
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women who can speak and understand the Urdu language
* Osteopenic with Lumbar spine or femur T-score between -1 to -2.5
* Osteoporotic with Lumbar spine or femur T-score less than -2.5.

Exclusion Criteria:

* Impairment of communicative and sensorial functions
* Impaired Cognition
* Unstable angina
* disease requiring oxygen therapy and Symptomatic orthostatic hypotension
* Hypertension in poor pharmacologic control (diastolic \>95 mmHg, systolic \>160 mmHg)
* Neurological disorders

Primary outcomes:
measure: ECOS-16 Quality of Life Questionnaire
timeFrame: 6 Months
Secondary outcomes:
measure: Reliability of Urdu translated version
timeFrame: 6 Months
measure: Validity of Urdu Translated version
timeFrame: 6 Months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Saima Riaz
state: Punjab
Study officials:
affiliation: Riphah International University
name: Syed Shakil Ur Rehman, PhD
role: STUDY_CHAIR
affiliation: Riphah International University
name: Saima Riaz, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
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