Idiopathic Parkinson DiseaseNCT07023224
Reliability and Validity Study of the Turkish Version of the Parkinson's Disease Dyskinesia Scale (PDYS-26)
An observational study of Idiopathic Parkinson Disease and Dyskinesias, run by Izmir Bakircay University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Parkinson Disease, Dyskinesias, Quality of Life
- What is being tested?
- Turkish version of the Parkinson's Disease Dyskinesia Scale (PDYS-26)
- How many people
- 130 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 14 Nov 2024to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Being diagnosed with idiopathic Parkinson's disease
- H\&Y stage 1-3
- UPDRS dyskinesia item score ≥1
- Accepting to participate in the study
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Bakirçay University Çiğli Regional Education Hospital
Izmir, İ̇zmi̇r, 35000
- Recruiting
Izmir Bakırçay Univercity
Izmir, 35000
About this study
Official title: Adaptation Of The Parkinson's Disease Dyskinesia Questionnaire Into Turkish And Its Validity And Reliability In Parkinson's Patient
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.
Read the detailed description
In Parkinson's disease, a neurodegenerative disorder affecting the peripheral and central nervous system, dyskinesia is a common symptom that occurs as disease processes progress and leads to disability. The term dyskinesia is a general term that covers many movement disorders. In general, it can be defined as mild to severe abnormal and involuntary muscle movements. In individuals with Parkinson's disease, it is a natural consequence of the neurodegenerative process and a motor complication of the gold standard L-dopa. Assessment of dyskinesia in Parkinson's patients is important for the implementation of appropriate medical, surgical and rehabilitation protocols. There are few scales and patient diaries that clinically assess the effect of interventions for dyskinesia. At the same time, there are deficiencies related to the reliability and validity studies of these existing scales in different languages. Therefore, limitations may arise in the assessment of dyskinesia. For this purpose, our study aims to investigate the reliability and validity of the Parkinson's Disease Dyskinesia Scale (PDYS-26) in Turkish in patients diagnosed with 130 idiopathic Parkinson's patients.In the study, the Parkinson's Disease Dyskinesia Scale (PDYS-26) will be translated into Turkish with the "back translation" method and will be finalized after the approval of the commission consisting of relevant health professionals. The final version of the scale will be applied to Parkinson's patients. 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.
- Conditions
- Idiopathic Parkinson Disease, Dyskinesias, Quality of Life
- Being tested
- Turkish version of the Parkinson's Disease Dyskinesia Scale (PDYS-26)
- Keywords
- Parkinson's disease, Dyskinesia, Parkinson's Disease Dyskinesia Scale
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish version of the Parkinson's Disease Dyskinesia Scale (PDYS-26)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Turkish version of the Parkinson's Disease Dyskinesia Scale (PDYS-26) |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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.
Measured: Baseline (Day 1) and 7 days post-baseline (Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start14 Nov 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Tepe Bark, Izmir Bakircay University
- Investigators
- Gulbın Ergın, PT, PhD, Principal investigator, Izmir Bakircay Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023224
- Sponsor's protocol ID
- IZBU-FTR-ITB-01
- Status last verified
- Sep 2025
- First submitted
- 28 May 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared beyond the research team due to ethical and confidentiality considerations.
Publications
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.
PubMed 17679674
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation Of The Parkinson's Disease Dyskinesia Questionnaire Into Turkish And Its Validity And Reliability In Parkinson's Patient
- ClinicalTrials.gov ID
- NCT07023224
- Acronym / sponsor ID
- IZBU-FTR-ITB-01
- Conditions
- Idiopathic Parkinson Disease, Dyskinesias, Quality of Life
- Keywords
- Parkinson's disease, Dyskinesia, Parkinson's Disease Dyskinesia Scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 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 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.
Detailed description
In Parkinson's disease, a neurodegenerative disorder affecting the peripheral and central nervous system, dyskinesia is a common symptom that occurs as disease processes progress and leads to disability. The term dyskinesia is a general term that covers many movement disorders. In general, it can be defined as mild to severe abnormal and involuntary muscle movements. In individuals with Parkinson's disease, it is a natural consequence of the neurodegenerative process and a motor complication of the gold standard L-dopa. Assessment of dyskinesia in Parkinson's patients is important for the implementation of appropriate medical, surgical and rehabilitation protocols. There are few scales and patient diaries that clinically assess the effect of interventions for dyskinesia. At the same time, there are deficiencies related to the reliability and validity studies of these existing scales in different languages. Therefore, limitations may arise in the assessment of dyskinesia. For this purpose, our study aims to investigate the reliability and validity of the Parkinson's Disease Dyskinesia Scale (PDYS-26) in Turkish in patients diagnosed with 130 idiopathic Parkinson's patients.In the study, the Parkinson's Disease Dyskinesia Scale (PDYS-26) will be translated into Turkish with the "back translation" method and will be finalized after the approval of the commission consisting of relevant health professionals. The final version of the scale will be applied to Parkinson's patients. 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson Patients with Dyskinesia | – | Other: Turkish version of the Parkinson's Disease Dyskinesia Scale (PDYS-26)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Being diagnosed with idiopathic Parkinson's disease
- H\&Y stage 1-3
- UPDRS dyskinesia item score ≥1
- Accepting to participate in the study
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Turkish version of the Parkinson's Disease Dyskinesia Scale (PDYS-26)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. | Other | Parkinson Patients with Dyskinesia |
Primary outcome
(PDYS-26)
Time frame: Baseline (Day 1) and 7 days post-baseline (Day 8)
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.
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 19 Sep 2025.
- Background: PubMed 17679674Katzenschlager 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.
- The original publication of the scale that is the subject of the Turkish adaptation studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data will be shared beyond the research team due to ethical and confidentiality considerations.
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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.
Gulbın Ergın, PT, PhD principal investigator
Izmir Bakircay Univercity
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Parkinson Disease and Dyskinesias, run by Izmir Bakircay University at 2 sites 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: looking for participants now, as of the sponsor's last update on 19 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 2 sites 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?
Contact Irem Tepe Bark, PT (+905537491143, fztiremtepe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(PDYS-26) (time frame: Baseline (Day 1) and 7 days post-baseline (Day 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07023224, which also lists 1 linked publication.
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 19 Sep 2025.