RecruitingNCT06483620

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

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


Sponsor

Cairo University

Enrollment

290 participants

Start Date

Feb 13, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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).

Interventions

DIAGNOSTIC_TESTNeuropathy - 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


Locations(1)

Faculty of Physical Therapy, Cairo University

Cairo, Giza Governorate, Egypt

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NCT06483620


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