Actively Recruiting
Neuropathy and Foot Ulcer-Specific Quality of Life Instrument Arabic Version Cross-cultural Adaptation, Validity, and Reliability for Patients With Type 2 Diabetes
Led by Cairo University · Updated on 2025-10-03
290
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a study to translate, culturally adapt, validate, and test the reliability of the Neuro Qol questionnaire in Arabic for diabetic patients with peripheral neuropathy and diabetic foot ulcers. This cross-cultural validation aims to produce a version suitable for use in Arabic-speaking countries, as no Arabic version currently exists. The study focuses on assessing quality of life related to neuropathy and foot ulcers among Arabic-speaking diabetic patients. The study involves translating the Neuro Qol questionnaire through a careful process including forward and backward translation, expert panel review, and harmonization. Participants include 290 diabetic patients aged 18 to 70 years who can read and write Arabic. They will complete the Arabic Neuro Qol as well as the Michigan Diabetic Neuropathy Scale (MDNS) in Arabic. The study includes two clinic visits spaced 7 to 14 days apart, with clinical examinations and data collection performed by trained staff. Participants will be initially screened and consented during the first visit, where demographic and clinical data will be collected. At the second visit, patients will complete additional questionnaires and report symptoms. Researchers will measure the cross-cultural validity, reliability, and adaptation of the Arabic Neuro Qol over an average of six months. The study will also monitor for diabetic neuropathy symptoms and related complications to ensure comprehensive assessment.
CONDITIONS
Brief Title
Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Arabic is the participant's first language
- Age is between 18 and 70 years
- Diagnosed with diabetes mellitus type 2 confirmed by physician and hemoglobin A1c ≥ 6.5% or use of hypoglycemic agents
- Able to read and write in Arabic
- Conscious and able to walk (ambulant)
You will not qualify if you...
- Currently a hospital inpatient
- Presence of other neurological diagnoses affecting sensory or motor systems such as stroke or multiple sclerosis
- Pregnant patients
- History of cancer, shingles, or other neuropathic pain conditions not caused by diabetes
- Recent physical trauma contributing to neuropathic pain
- Dermatological diseases affecting skin sensitivity such as wounds, psoriasis, or eczema
- Congenital deformities, fixed spinal deformity, rheumatoid arthritis, bone disease, or infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Same day as screening and enrollment
Participants complete the Arabic NeuroQOL questionnaire and undergo a clinical examination of the foot to assess symptoms such as loss of feeling, pain, discomfort, ulcers, and unsteadiness.
1 visit (in-person) during screening and enrollment visit
Duration - 7 to 14 days after initial visit
Participants return after 7 to 14 days to complete the Michigan Diabetic Neuropathy Scale (MDNS) Arabic version and report any additional symptoms or complications related to diabetes.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Faculty of Physical Therapy, Cairo University
Cairo, Giza Governorate, Egypt, 11432
Actively Recruiting
Research Team
E
Engy BadrEldin S Moustafa, PhD
S
Shimaa T. AbulKasem, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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