Clinical trial NCT06483620: Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY of LIFE Questionnaire
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Neuropathies
Diabetic Peripheral Neuropathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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?

Detailed description: The Neuropathy- and Foot Ulcer-Specific Quality of Life instrument (Neuro QOL) is used worldwide to assess the QOL of diabetic patients with peripheral neuropathy. There is no Arabic version of NeuroQOL for use in Egypt.

The study design will be 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 Neuro Qol 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 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 the following criteria: Their age ranged between 18-70 years , with type 2 diabetes referred by physician, conscious and ambulant, and being able to read and write in Arabic.

Patients suffering from congenital deformities, fixed spinal deformity, rheumatoid arthritis, bone disease, or infection were excluded from the study.

Participants will be identified, approached, and recruited from outpatient clinics at the Faculty of Physical Therapy, Nahda University, and El-Salam University. The study will be advertised through posters and word of mouth. Participants will receive a participant information sheet and a self-screening eligibility form, and they will be asked to contact the Principal Investigator (SG) no sooner than 48 hours if they wish to volunteer to participate in the study, which consisted of two visits to the clinic.

During study visit 1, participants will be briefed about the study, screened for eligibility, and enrolled in the study by signing a consent form.

Demographic data, such as age, weight, and height, will also be collected to describe the sample. The principal investigator will apply the clinical examination for the foot and assess any problems such as lost or reduced feeling in your extremities, pain, discomfort, and/or ulcers (open sores) on your feet, and, in some cases, unsteadiness while walking or standing. Participants will then complete the Arabic NeuroQOL. A nurse assisted participants with reading difficulties.

Participants will return for study visit 2 after 7-14 days and will complete the Michigan Diabetic Neuropathy Scale (MDNS)-Arabic version. Participants will also be required to report other symptoms and complications associated with diabetes.

The translation process will follow the Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcome Measures using the following steps:

1. Preparation: Four bilingual translators who are fluent in Arabic and English will be selected. Three translators are clinicians and one translator is a university academic.
2. Forward translation: the NeuroQOL will be given to all translators to translate into Arabic.
3. Reconciliation: The four translated documents will be shared between all translators, and discrepancies, ambiguities, and issues arising will be discussed and resolved and a final draft Arabic version of the NeuroQOL will be produced.
4. Backward translation and review: The final draft Arabic version of the NeuroQOL will be translated back into English by a translator who had not been involved in forward translation and who was blind to the original English version of the NeuroQOL.
5. Harmonization, cognitive debriefing and reviewing of results: The back-translated The English version of the NeuroQOL will be compared with the original NeuroQOL, and discrepancies, ambiguities, and typographic and/or grammatical errors will be discussed within the group and in the final draft of the Arabic version.
6. Proofreading and final report: When the authenticity of the translation has been agreed upon by consensus, the final version of the Arabic-NeuroQOL will be produced.

Eligibility criteria: 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 outcomes:
measure: Cross-cultural validation of the Arabic-translated NEURQOL Questionnaire.
timeFrame: Baseline and through study completion, an average of 6 months.
measure: Reliability of the Arabic-translated NEURQOL Questionnaire.
timeFrame: Baseline and through study completion, an average of 6 months.
measure: Cross-cultural adaptation of the Arabic-translated NEURQOL Questionnaire.
timeFrame: Baseline and through study completion, an average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Cairo University, Egypt
name: Engy BadrEldin S Moustafa, PhD
role: PRINCIPAL_INVESTIGATOR
References: