Validity and SafetyMOSNCT07033390
Monitor Orthopaedic Footwear Questionnaire (MOS) Validity and Reliability Study
An observational study of Validity and Safety, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to adapt the MOS questionnaire into Turkish and to investigate the validity and reliability of the questionnaire. In this study, Monitor Orthopaedic Shoes Questionnaire (MOS) will be translated into Turkish and named as MOS-T. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Validity and Safety
- What is being tested?
- survey
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2025to 30 Nov 2025
- 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 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals using insoles
Who may be able to join
- • Wearing orthopedic shoes for the first time,
- Being 16 years old and above,
- Being a native Turkish speaker and having at least a literacy level,
- Being able to complete the survey without assistance regarding cognitive or physical disorders,
- Volunteering to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Medipol University
Beykoz, Istanbul, 34290
About this study
Official title: Adaptation of Monitor Orthopaedic Footwear Questionnaire (MOS) Into Turkish: Validity and Reliability Study
The aim of the study is to adapt the MOS questionnaire into Turkish and to investigate the validity and reliability of the questionnaire. In this study, Monitor Orthopaedic Shoes Questionnaire (MOS) will be translated into Turkish and named as MOS-T.
The research is a methodological study conducted to determine the validity and reliability of the Turkish adaptation of the MOS. For this purpose, the questionnaire will be translated into Turkish, cultural adaptation of the Turkish version will be made, and its validity and reliability will be tested.In accordance with the validity and reliability research, MOS will be reapplied to the participants after 8 weeks to evaluate the test-retest reliability.
Read more
Inclusion Criteria
- Wearing orthopaedic shoes for the first time,
- 16 years of age or older,
- Native language is Turkish and at least literacy level,
- Able to complete the questionnaire without assistance with cognitive or physical impairments,
- Who volunteered to participate in the study
Read the detailed description
The translation procedure and cross-cultural adaptation of the MOS will be carried out according to the predetermined cross-cultural adaptation principles of Beaton et al. For the development of the Turkish adaptation of the MOS and the validity and reliability study, permission was obtained by e-mail from Jaap Van Netten, the first author of the original questionnaire. Firstly, two independent translators will translate the original questionnaire from English to Turkish. One of the translators will be informed about the study, the other will not be informed about the study. A draft version, which is a synthesis of these two different translations, will be prepared by a team of experts from different disciplines. The draft version will be back-translated from Turkish to English by two independent translators who are native speakers of English and fluent in Turkish to ensure that the translation expresses the same article content as the original English version. The expert team will review the translated English version and finalise the Turkish draft by deciding whether the Turkish version reflects the content of the original MOS. Finally, a pilot study will be conducted to test the items to be modified and deleted before the final Turkish version is created. After the pilot study, the final version of the Turkish version of the MOS will be created.
- Conditions
- Validity and Safety
- Being tested
- survey
- Keywords
- validity, reability, orthopedic shoes, survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
validity and reliability study of MOS
What is being measured
The primary outcome is the main question the study is designed to answer.
validity
RMSEA and CFI values in confirmatory factor analysis
Measured: 2-month change
reliability
Cronbach's alpha and ICC value
Measured: 2-month change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validity and SafetyStudies of the same condition, open and under way.
- More trials run by Medipol 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande YAZICI, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033390
- Sponsor's protocol ID
- İsciH
- Acronym
- MOS
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Monitor Orthopaedic Footwear Questionnaire (MOS) Into Turkish: Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT07033390
- Acronym / sponsor ID
- MOS / İsciH
- Conditions
- Validity and Safety
- Keywords
- validity, reability, orthopedic shoes, survey
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 24 Jun 2025 (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.
The aim of the study is to adapt the MOS questionnaire into Turkish and to investigate the validity and reliability of the questionnaire. In this study, Monitor Orthopaedic Shoes Questionnaire (MOS) will be translated into Turkish and named as MOS-T.
The research is a methodological study conducted to determine the validity and reliability of the Turkish adaptation of the MOS. For this purpose, the questionnaire will be translated into Turkish, cultural adaptation of the Turkish version will be made, and its validity and reliability will be tested.In accordance with the validity and reliability research, MOS will be reapplied to the participants after 8 weeks to evaluate the test-retest reliability.
Inclusion Criteria
- Wearing orthopaedic shoes for the first time,
- 16 years of age or older,
- Native language is Turkish and at least literacy level,
- Able to complete the questionnaire without assistance with cognitive or physical impairments,
- Who volunteered to participate in the study
Detailed description
The translation procedure and cross-cultural adaptation of the MOS will be carried out according to the predetermined cross-cultural adaptation principles of Beaton et al. For the development of the Turkish adaptation of the MOS and the validity and reliability study, permission was obtained by e-mail from Jaap Van Netten, the first author of the original questionnaire. Firstly, two independent translators will translate the original questionnaire from English to Turkish. One of the translators will be informed about the study, the other will not be informed about the study. A draft version, which is a synthesis of these two different translations, will be prepared by a team of experts from different disciplines. The draft version will be back-translated from Turkish to English by two independent translators who are native speakers of English and fluent in Turkish to ensure that the translation expresses the same article content as the original English version. The expert team will review the translated English version and finalise the Turkish draft by deciding whether the Turkish version reflects the content of the original MOS. Finally, a pilot study will be conducted to test the items to be modified and deleted before the final Turkish version is created. After the pilot study, the final version of the Turkish version of the MOS will be created.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals using insoles
Key inclusion criteria (5 listed)
- • Wearing orthopedic shoes for the first time,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| surveyvalidity and reliability study of MOS | Other | – |
Primary outcome
validity
Time frame: 2-month change
RMSEA and CFI values in confirmatory factor analysis
reliability
Time frame: 2-month change
Cronbach's alpha and ICC value
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 24 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Validity and Safety
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Validity and Safety, run by Medipol University at 1 site in Turkey (Türkiye).
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 5 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 24 Jun 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity (time frame: 2-month change). The study lists 2 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 24 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.