NCT07023224

Brief Summary

The aim of this methodological study was to investigate the Turkish validity and reliability of the Parkinson's Disease Dyskinesia Scale (PDYS-26).The scale evaluates choreic dyskinesia.Measures the impact of dyskinesia on activities of daily living in patients with Parkinson's disease. Hypotheses of the Study:

  • Parkinson's Disease Dyskinesia Scale (PDYS-26) is reliable in Turkish.
  • Parkinson's Disease Dyskinesia Scale (PDYS-26) is valid in Turkish. To determine the validity of dyskinesia;
  • Tampa Kinesiophobia Scale,
  • Mini BesTest,
  • Activity Specific Balance Safety Scale (ABC) and
  • Parkinson's Disease Questionnaire-39 will be evaluated.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

May 28, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

Parkinson's diseaseDyskinesiaParkinson's Disease Dyskinesia Scale

Outcome Measures

Primary Outcomes (1)

  • (PDYS-26)

    Turkish version of Parkinson's Disease Dyskinesia Scale: It is a questionnaire that assesses the impact of dyskinesia on activities of daily living. It consists of 26 items. A higher score indicates greater impact.It is considered a consistent, reliable, and valid measure. It is easy to complete and has a short administration time.

    Baseline (Day 1) and 7 days post-baseline (Day 8)

Other Outcomes (4)

  • Tampa Kinesiophobia Scale

    Baseline (Day 1)

  • (Mini-BesTest)

    Baseline (Day 1)

  • (ABC)

    Baseline (Day 1)

  • +1 more other outcomes

Study Arms (1)

Parkinson Patients with Dyskinesia

Parkinson's disease patients with a Unified Parkinson's Disease Rating Scale (UPDRS) dyskinesia score of ≥1. Participants must meet the inclusion criteria and provide informed consent.

Other: Turkish version of the Parkinson's Disease Dyskinesia Scale (PDYS-26)

Interventions

The Turkish adaptation of the Parkinson's Disease Dyskinesia Scale (PDYS-26) is administered to individuals diagnosed with Parkinson's disease who have a dyskinesia score of ≥1 based on the Unified Parkinson's Disease Rating Scale (UPDRS) dyskinesia item. The scale is used to evaluate dyskinesia severity and assess its clinical applicability in Turkish-speaking populations.

Parkinson Patients with Dyskinesia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study was planned as a methodological research. For this purpose, Parkinson's disease patients who applied to Izmir Çiğli Training and Research Hospital Neurology Outpatient Clinic and met the inclusion criteria will be included in the study. Written informed consent will be obtained from individuals who agree to participate in the study. Based on the commonly recommended participant-to-item ratio in validity and reliability studies (typically 5 to 10 participants per item), the sample size was determined as five times the number of items in the 26-item PDYS-26 scale, and a total of 130 patients with Parkinson's disease were included in the study.

You may qualify if:

  • Being diagnosed with idiopathic Parkinson's disease
  • H\&Y stage 1-3
  • UPDRS dyskinesia item score ≥1
  • Accepting to participate in the study

You may not qualify if:

  • Diagnosis of atypical-secondary parkinsonism
  • Severe musculoskeletal, neurological and/or cardiopulmonary problems that may affect the results of the assessment
  • Mini Mental State Examination score \< 24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bakirçay University Çiğli Regional Education Hospital

Izmir, İ̇zmi̇r, 35000, Turkey (Türkiye)

RECRUITING

Izmir Bakırçay Univercity

Izmir, 35000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Katzenschlager R, Schrag A, Evans A, Manson A, Carroll CB, Ottaviani D, Lees AJ, Hobart J. Quantifying the impact of dyskinesias in PD: the PDYS-26: a patient-based outcome measure. Neurology. 2007 Aug 7;69(6):555-63. doi: 10.1212/01.wnl.0000266669.18308.af.

    PMID: 17679674BACKGROUND

Related Links

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gulbın Ergın, PT, PhD

    Izmir Bakircay Univercity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irem Tepe Bark, PT

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 15, 2025

Study Start

November 14, 2024

Primary Completion

November 30, 2025

Study Completion

December 1, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared beyond the research team due to ethical and confidentiality considerations.

Locations