- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06630026
Examining the Validity and Reliability of the Dresden Falls Questionnaire in Patients With Parkinson's Diagnosis Living in Turkey (DREFAQ)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye), 34720
- İstanbul Medeniyet University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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,
Exclusion Criteria:
- communication or cognitive problems,
- aphasia and speech disorders
- unstable medical conditions
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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• 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Falls
Time Frame: Baseline
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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.
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Baseline
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Falls Efficacy
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Health-Related Quality of Life (HRQoL)
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/115 DREFAQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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