Diabetic NeuropathiesNCT06483620
Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire
An observational study of Diabetic Neuropathies and Diabetic Peripheral Neuropathy, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Neuropathies, Diabetic Peripheral Neuropathy
- What is being tested?
- Neuropathy - and Foot Ulcer - Specific Quality of Life instrument (Neuro Qol)
- How many people
- 290 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Feb 2025to 25 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University
Cairo, Giza Governorate, 11432
Engy BadrEldin S Moustafa, PhD, 00201099445112, engybm.saleh@cu.edu.eg
Shimaa T. AbulKasem, PhD, 00201229823327, dr.shymaelshazly@yahoo.com
About this study
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
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.
Read more
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?
Read the 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:
- 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.
- Forward translation: the NeuroQOL will be given to all translators to translate into Arabic.
- 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.
- 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.
- 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.
- 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.
- Being tested
- Neuropathy - and Foot Ulcer - Specific Quality of Life instrument (Neuro Qol)
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Neuropathy - and Foot Ulcer - Specific Quality of Life instrument (Neuro Qol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start13 Feb 2025
- Primary completion20 Dec 2025 (estimated)
- Study completion25 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Badreldin Saleh Moustafa, PhD, Cairo University
- Investigators
- Engy BadrEldin S Moustafa, PhD, Principal investigator, Faculty of Physical Therapy, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483620
- Sponsor's protocol ID
- P.T.REC/012/005051
- Status last verified
- Dec 2024
- First submitted
- 11 Jun 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06483620
- Acronym / sponsor ID
- P.T.REC/012/005051
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 25 Jan 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Forward translation: the NeuroQOL will be given to all translators to translate into Arabic.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Neuropathy group | – | Diagnostic Test: Neuropathy - and Foot Ulcer - Specific Quality of Life instrument (Neuro Qol)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropathy - 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 | Diagnostic test | Diabetic Neuropathy group |
Primary outcome
Cross-cultural validation of the Arabic-translated NEURQOL Questionnaire.
Time frame: Baseline and through study completion, an average of 6 months.
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.
Reliability of the Arabic-translated NEURQOL Questionnaire.
Time frame: Baseline and through study completion, an average of 6 months.
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.
Cross-cultural adaptation of the Arabic-translated NEURQOL Questionnaire.
Time frame: Baseline and through study completion, an average of 6 months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Engy BadrEldin S Moustafa, PhD principal investigator
Faculty of Physical Therapy, Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Neuropathies and Diabetic Peripheral Neuropathy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Engy BadrEldin S Moustafa, PhD (00201099445112, engybm.saleh@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-cultural validation of the Arabic-translated NEURQOL Questionnaire. (time frame: Baseline and through study completion, an average of 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.