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

NCT06483620 | Recruiting

• 1 other identifier: P.T.REC/012/005051
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Diabetic Neuropathies; Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (3)

• Cross-cultural validation of the Arabic-translated NEURQOL Questionnaire.

  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.

  Baseline and through study completion, an average of 6 months.

• Reliability of the Arabic-translated NEURQOL Questionnaire.

  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.

  Baseline and through study completion, an average of 6 months.

• Cross-cultural adaptation of the Arabic-translated NEURQOL Questionnaire.

  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.

  Baseline and through study completion, an average of 6 months.

Study Arms (1)

Diabetic Neuropathy group

The study design was a cross-cultural validation of Neuro Qol the Arabic version, for patients with DFUs. Three expert panels were involved in this study to test the face and content validity of the NeuroQol Arabic version. All experts had experience of not less than 10 years or at least a master's degree in physical therapy; a major part of their work is with the Arabic population; and they were also fluent in Arabic and English. Ten patients per item were chosen to estimate the sample size for testing the psychometric properties of the Neuro Qol Arabic version. So 290 patients (145 male patients and 145 female patients), were chosen according to specific eligibility criteria.

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

Interventions

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

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

Diabetic Neuropathy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study design will be a cross-cultural validation of Neuro Qol the Arabic version for patients with DFUs. Participants will be identified, approached, and recruited from outpatient clinic at Faculty of Physical Therapy, Nahda University and Elsalam university. Ten patients per item were chosen to estimate the sample size for testing the psychometric properties of the Neuro Qol Arabic version (Sousa \& Rojjanasrirat, 2011). So 290 patients (145 male patients and 145 female patients), were chosen according to specific criterea.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Cairo, Giza Governorate, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Engy BadrEldin S Moustafa, PhD

  Faculty of Physical Therapy, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Engy BadrEldin S Moustafa, PhD

CONTACT

00201099445112; engybm.saleh@cu.edu.eg

Shimaa T. AbulKasem, PhD

CONTACT

00201229823327; dr.shymaelshazly@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 3, 2024
• Study Start: February 13, 2025
• Primary Completion: December 20, 2025
• Study Completion: January 25, 2026
• Last Updated: October 3, 2025

Record last verified: 2024-12

Locations

EG (1)