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Recruiting Observational

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

NCT06483620 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2025-02-13
Last updated
2025-10-03

Condition(s) studied

Diabetic NeuropathiesDiabetic Peripheral Neuropathy

Investigational drug(s) / intervention(s)

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

Neuropathy - 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

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Arabic is their first language The absence of any other neurological diagnosis affecting the sensory and motor system, such as stroke or multiple sclerosis * Age ranges between 18 and 70 years, * History of DM diagnosed by a physician and confirmed by either hemoglobin A1c ≥6.5% or the use of hypoglycemic agents. Exclusion Criteria: * A hospital inpatient * Had pre-existing comorbidities such as cancer, shingles or other neuropathic pain entity that predated diabetes or can mimic or cause a neuropathic pain that is not arising as a result of diabetes. * Pregnant patients as diabetes may be of gestational type * Had recently experienced physical trauma that may have contributed to neuropathic pain had trauma or dermatological diseases of the skin as this could affect skin sensitivity (e.g. wounds, psoriasis and eczema).

Primary outcome measure(s)

  • Cross-cultural validation of the Arabic-translated NEURQOL Questionnaire. — Baseline and through study completion, an average of 6 months.
    Cross-cultural validation involves three main phases: 1) translation and verification of its equivalence; traditional translation simply involves translation of the original instrument by a bilingual researcher or professional translator. 2) empirical verification of the validity of the translated version; it involves the participation of a number of bilingual people familiar with the field in which the instrument is to be used, which also limits the biases of a single researcher. and 3) adaptation of the scores to the cultural context, and the development of standards. It involves having a preliminary translated version of the instrument translated back into the original language by a second person. The discrepancies between the original version and the retranslated version help identify problematic items.
  • Reliability of the Arabic-translated NEURQOL Questionnaire. — Baseline and through study completion, an average of 6 months.
    It considers the extent to which the questions used in the NeurQoL questionnaire consistently elicit the same results each time it is asked in the same situation on repeated occasions. test-retest reliability. This involves administering the questionnaire to the eligible participants and repeating the survey with the same group at the end of the questionnaire validation. We then compare the responses at the two time points.
  • Cross-cultural adaptation of the Arabic-translated NEURQOL Questionnaire. — Baseline and through study completion, an average of 6 months.
    The process of translating and adapting questionnaires from one cultural context to another involves much more than converting the items from the source language to the target language. The questionnaire must be equivalent to the original, considering the new cultural context in which it will be applied. After translation, the scales were evaluated in meetings of a committee of experts in different scientific fields of interest, translators, and language professors. The updated questionnaire was then sent to six experts to assess the relevance of each item, the language, and the adopted response scales, and then to participants from the academic community and organizations human resources to improve item clarity.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Physical Therapy, Cairo University Cairo Giza Governorate Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06483620 on ClinicalTrials.gov ↗ ← All trials in Egypt