RecruitingNCT06483620

Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire

Neuropathy and Foot Ulcer_ Specific Quality of Life Instrument (Neuro QOL) Arabic Version: Cross-cultural Adaptation, Validity, and Reliability for Patients With Type 2 Diabetes


Sponsor

Cairo University

Enrollment

290 participants

Start Date

Feb 13, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

PURPOSE: This study will translate, culturally adapt, validate, and test the reliability of the Neuro Qol Arabic version to be used with diabetic patients in Arabic countries. Background: The Neuropathy- and Foot Ulcer-Specific Quality of Life instrument is a multidimensional scale was developed to assess the QoL of diabetic patients with peripheral neuropathy. Producing Arabic versions of the Translating Scale can help researchers investigate offloading treatment among the Arabic population with DFUs. Hypotheses: The study design was a cross-cultural validation of NeuroQol, the Arabic version, for patients with DFUs. Research Question: Will there be cultural adaptation, validation, and reliability between the (Neuro Qol) Arabic version and the original language?


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is translating a quality-of-life questionnaire about diabetic neuropathy (nerve damage caused by diabetes) into Arabic and testing whether it is valid and reliable for Arabic-speaking patients. Diabetic neuropathy causes pain, numbness, and tingling — mainly in the feet and hands — and this tool would help doctors assess its impact on patients' lives. **You may be eligible if...** - Arabic is your first language - You are 18–70 years old - You have been diagnosed with diabetes by a doctor, confirmed by an HbA1c of 6.5% or higher, or by use of diabetes medications **You may NOT be eligible if...** - You are hospitalized - You have another neurological condition (such as stroke or multiple sclerosis) that could cause similar symptoms - You are pregnant (diabetes may be gestational in nature) - You have a recent injury or skin condition that could cause nerve pain unrelated to diabetes - You have cancer, shingles, or another pre-existing neuropathic pain condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTNeuropathy - and Foot Ulcer - Specific Quality of Life instrument (Neuro Qol)

The NeuroQoL questionnaire is a valid, reliable, and self-reported questionnaire. It has 35-items with six domains namely, painful symptoms and paresthesia (items 1-7), reduction or loss of ability to feel (items 8-10), unsteadiness while walking/standing/diffuse sensory-motor symptoms (items 11-13), limitation in daily living (items 14 - 16), interpersonal problems (items 17-20), emotional distress (items 21- 27) and end with an overall assessment of quality of life or satisfaction with experiences in the above six domains \[1 item in each domains, i.e. additional 6 items (items 28-33)\]. The two final items (items 34-35) assess overall impact of neuropathy on QoL \[5\]. The scoring of the questionnaire is according to a five-point Likert scale, all the time, most of the time, some of the time, occasionally, never. Each domain has a maximum score 5 and minimum 1, where 5 means that the QoL is affected all the time because of the foot problem while 1 means never it affects their QoL


Locations(1)

Faculty of Physical Therapy, Cairo University

Cairo, Giza Governorate, Egypt

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NCT06483620


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