Validating an Arabic version of a quality of life questionnaire for diabetic neuropathy patients
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
This study is trying to create and test an Arabic version of a quality of life questionnaire for Arabic-speaking patients with diabetic neuropathy to make sure it works well for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 290 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Giza Governorate) |
| Trial ID | NCT06483620 on ClinicalTrials.gov |
What this trial studies
This study aims to translate, culturally adapt, and validate the Neuro QOL questionnaire for Arabic-speaking diabetic patients suffering from peripheral neuropathy. It involves a cross-cultural validation process to ensure that the Arabic version maintains the reliability and validity of the original instrument. The study will recruit 290 participants aged 18-70 years from outpatient clinics, focusing on those with type 2 diabetes. Expert panels will assess the face and content validity of the translated questionnaire.
Who should consider this trial
Good fit: Ideal candidates for this study are Arabic-speaking adults aged 18-70 with a diagnosis of type 2 diabetes and no other neurological conditions.
Not a fit: Patients with congenital deformities, other neurological diagnoses, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable tool for assessing the quality of life in Arabic-speaking diabetic patients, leading to better-targeted treatments.
How similar studies have performed: While this specific adaptation is novel, similar studies have successfully validated quality of life instruments in other languages and cultures.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Cairo, Giza Governorate
- Faculty of Physical Therapy, Cairo University — Cairo, Giza Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Engy BadrEldin S Moustafa, PhD — Faculty of Physical Therapy, Cairo University, Egypt
- Study coordinator: Engy BadrEldin S Moustafa, PhD
- Email: engybm.saleh@cu.edu.eg
- Phone: 00201099445112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.