Parkinson DiseaseDREFAQNCT06630026
Examining the Validity and Reliability of the Dresden Falls Questionnaire in Patients With Parkinson's Diagnosis Living in Turkey
An observational study of Parkinson Disease and Falls, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ) to Turkish society and to make its validity and reliability in Turkish. The DREFAQ) scale developed by Frank, Anika, et al assesses falls in patients with Parkinson. It has 5 questions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, Falls, Scale Reliability Validity
- What is being tested?
- The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ)scale to Turkish society in Parkinson patients and to make its validity and reliability in Turkish.
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 30 Mar 2025
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson patients who are aged 18-80 years with Hoehn \& Yahr score between 1-4 and able to speak and read Turkish.
Who may be able to join
- Individuals with a Hoehn \& Yahr score between 1-4,
- Individuals who can ambulate with or without assistive equipment,
- Individuals with a Mini Mental State Examination score of >24,
- Individuals with a history of falling at least once in the last year,
Who cannot join
- communication or cognitive problems,
- aphasia and speech disorders
- unstable medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ) to Turkish society and to make its validity and reliability in Turkish. The DREFAQ) scale developed by Frank, Anika, et al assesses falls in patients with Parkinson. It has 5 questions. This study will be conducted with Parkinson patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 50 participants will be included in the study. In order to evaluate the validity of the DREFAQ, the Modified Falls Efficacy Scale (MFES), which can evaluate the efficacy of falls and has been validated in Turkish, and the Parkinson's Disease Quality of Life (PDQOL) questionnaire, which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.
Read the detailed description
The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.
The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale, Frank, Anika, et al approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of DREFAQ will be able to be modified. The data of DREFAQ are collecting through face-to-face when the patients came to the rehabilitation center. 50 participants will be included in the study.
In order to evaluate the validity of the DREFAQ, the Modified Falls Efficacy Scale (MFES), which can evaluate the efficacy of falls and has been validated in Turkish, and the Parkinson's Disease Quality of Life (PDQOL) questionnaire, which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.
- Conditions
- Parkinson Disease, Falls, Scale Reliability Validity
- Being tested
- The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ)scale to Turkish society in Parkinson patients and to make its validity and reliability in Turkish.
- Keywords
- Parkinson disease, Falls, Scale reliability validity
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ)scale to Turkish society in Parkinson patients and to make its validity and reliability in Turkish.Other
- The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ)scale to Turkish society and to make its validity and reliability in Turkish. It has 5 questions. This study will be conducted with Parkinson patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Patients | Parkinson patients who are aged 18-80 years with Hoehn \& Yahr scale between 1-4 and able to speak and read Turkish, will recruit to the study. Receives: Other: The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ)scale to Turkish society in Parkinson patients and to make its validity and reliability in Turkish. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls
Falls will be assessed with the Dresden Falls Questionnaire scale (DREFAQ). DREFAQ consists of 5 items in total. Items 1 to 4 are scored from 0 to 3. The total score of the DREFAQ is calculated by summing the first 4 items (0-12). The location of the injury (from item 4) and the circumstances (item 5) are not used in the score calculation but provide additional qualitative information. Higher scores indicate a high risk of falling.
Measured: Baseline
Falls Efficacy
Falls efficacy will be assessed with the Modified Falls Efficacy Scale (MFES) scale. The MFES consists of 14 items in total. Items are scored from 0 (not sure of himself/herself) to 10 (totally confident). Total score is between 0-140. Lower scores indicate a high risk of falling.
Measured: Baseline
Secondary outcomes (1)
Health-Related Quality of Life (HRQoL)
Ouality of life will be assessed with the Parkinson's Disease Quality of Life (PDQOL) questionnaire. It consists of 8 questions in total. Items are scored 0 to 4. Total score is between 0-32. Higher scores indicate lower quality of life.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Oct 2024
- Primary completion15 Dec 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- 64 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Mete, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630026
- Sponsor's protocol ID
- 2024/115 DREFAQ
- Acronym
- DREFAQ
- Status last verified
- Aug 2025
- First submitted
- 4 Oct 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Validity and Reliability of the Dresden Falls Questionnaire in Patients With Parkinson's Diagnosis Living in Turkey
- ClinicalTrials.gov ID
- NCT06630026
- Acronym / sponsor ID
- DREFAQ / 2024/115 DREFAQ
- Conditions
- Parkinson Disease, Falls, Scale Reliability Validity
- Keywords
- Parkinson disease, Falls, Scale reliability validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 8 Oct 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.
The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ) to Turkish society and to make its validity and reliability in Turkish. The DREFAQ) scale developed by Frank, Anika, et al assesses falls in patients with Parkinson. It has 5 questions. This study will be conducted with Parkinson patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 50 participants will be included in the study. In order to evaluate the validity of the DREFAQ, the Modified Falls Efficacy Scale (MFES), which can evaluate the efficacy of falls and has been validated in Turkish, and the Parkinson's Disease Quality of Life (PDQOL) questionnaire, which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.
Detailed description
The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.
The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale, Frank, Anika, et al approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of DREFAQ will be able to be modified. The data of DREFAQ are collecting through face-to-face when the patients came to the rehabilitation center. 50 participants will be included in the study.
In order to evaluate the validity of the DREFAQ, the Modified Falls Efficacy Scale (MFES), which can evaluate the efficacy of falls and has been validated in Turkish, and the Parkinson's Disease Quality of Life (PDQOL) questionnaire, which can evaluate the quality of life and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson Patients | – | Other: The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ)scale to Turkish society in Parkinson patients and to make its validity and reliability in Turkish.Parkinson patients who are aged 18-80 years with Hoehn \& Yahr scale between 1-4 and able to speak and read Turkish, will recruit to the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson patients who are aged 18-80 years with Hoehn \& Yahr score between 1-4 and able to speak and read Turkish.
Key inclusion criteria (4 listed)
- Individuals with a Hoehn \& Yahr score between 1-4,
- Individuals who can ambulate with or without assistive equipment,
- Individuals with a Mini Mental State Examination score of >24,
- Individuals with a history of falling at least once in the last year,
Key exclusion criteria (3 listed)
- communication or cognitive problems,
- aphasia and speech disorders
- unstable medical conditions
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 |
|---|---|---|
| The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ)scale to Turkish society in Parkinson patients and to make its validity and reliability in Turkish.• The aim of this study is to adapt the Dresden Falls Questionnaire scale (DREFAQ)scale to Turkish society and to make its validity and reliability in Turkish. It has 5 questions. This study will be conducted with Parkinson patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions. | Other | Parkinson Patients |
Primary outcome
Falls
Time frame: Baseline
Falls will be assessed with the Dresden Falls Questionnaire scale (DREFAQ). DREFAQ consists of 5 items in total. Items 1 to 4 are scored from 0 to 3. The total score of the DREFAQ is calculated by summing the first 4 items (0-12). The location of the injury (from item 4) and the circumstances (item 5) are not used in the score calculation but provide additional qualitative information. Higher scores indicate a high risk of falling.
Falls Efficacy
Time frame: Baseline
Falls efficacy will be assessed with the Modified Falls Efficacy Scale (MFES) scale. The MFES consists of 14 items in total. Items are scored from 0 (not sure of himself/herself) to 10 (totally confident). Total score is between 0-140. Lower scores indicate a high risk of falling.
1 secondary outcome
Health-Related Quality of Life (HRQoL)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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. This study is not recruiting at the moment.
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 Parkinson Disease and Falls, run by Istanbul Medeniyet 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 2 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Falls (time frame: Baseline). 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 2 Sep 2025.