- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04873960
Translation and Cross -Cultural Validation of ECOS-16 Questionnaire in Urdu Language
Translation of ECOS-16 Questionnaire in Urdu Language; Validity and Reliability Analysis in Postmenopausal Women With Osteopenia
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Saima Riaz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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ECOS-16 Quality of Life Questionnaire
Time Frame: 6 Months
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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.
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6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reliability of Urdu translated version
Time Frame: 6 Months
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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.
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6 Months
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Validity of Urdu Translated version
Time Frame: 6 Months
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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.
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6 Months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Badia X, Diez-Perez A, Lahoz R, Lizan L, Nogues X, Iborra J. The ECOS-16 questionnaire for the evaluation of health related quality of life in post-menopausal women with osteoporosis. Health Qual Life Outcomes. 2004 Aug 3;2:41. doi: 10.1186/1477-7525-2-41.
- Salaffi F, Malavolta N, Cimmino MA, Di Matteo L, Scendoni P, Carotti M, Stancati A, Mule R, Frigato M, Gutierrez M, Grassi W; Italian Multicentre Osteoporotic Fracture (IMOF) Study Group. Validity and reliability of the Italian version of the ECOS-16 questionnaire in postmenopausal women with prevalent vertebral fractures due to osteoporosis. Clin Exp Rheumatol. 2007 May-Jun;25(3):390-403.
- Abourazzak FE, Allali F, Rostom S, Hmamouchi I, Ichchou L, El Mansouri L, Bennani L, Khazzani H, Abouqal R, Hajjaj-Hassouni N. Factors influencing quality of life in Moroccan postmenopausal women with osteoporotic vertebral fracture assessed by ECOS 16 questionnaire. Health Qual Life Outcomes. 2009 Mar 13;7:23. doi: 10.1186/1477-7525-7-23.
- Moradzadeh R, Moghimi N, Nadrian H, Behrouzi F, Keshavarz T, Golmohammadi P. Validity and reliability of the Farsi version of the ECOS-16 questionnaire for females with osteoporosis. East Mediterr Health J. 2018 Jan 2;23(11):729-733. doi: 10.26719/2017.23.11.729.
- Lee JS, Son SM, Goh TS, Kim TH, Noh EY. Validation of the ECOS-16 Questionnaire in Koreans with Osteoporosis. Asian Spine J. 2016 Oct;10(5):877-885. doi: 10.4184/asj.2016.10.5.877. Epub 2016 Oct 17.
- Madureira MM, Ciconelli RM, Pereira RM. Quality of life measurements in patients with osteoporosis and fractures. Clinics (Sao Paulo). 2012 Nov;67(11):1315-20. doi: 10.6061/clinics/2012(11)16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/21/1102/A Saima Riaz
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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