NCT06630026

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

October 4, 2024

Last Update Submit

August 25, 2025

Conditions

Keywords

Parkinson diseaseFallsScale reliability validity

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline

Secondary Outcomes (1)

  • Health-Related Quality of Life (HRQoL)

    Baseline

Study Arms (1)

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.

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.

Interventions

• 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.

Parkinson Patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson patients who are aged 18-80 years with Hoehn \& Yahr score between 1-4 and able to speak and read Turkish.

You may qualify if:

  • 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,

You may not qualify if:

  • communication or cognitive problems,
  • aphasia and speech disorders
  • unstable medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Medeniyet University

Istanbul, 34720, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Research Assistant

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

October 15, 2024

Primary Completion

December 15, 2024

Study Completion

March 30, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations