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CognitionNCT07253376

Turkish Validation of the Parkinson Disease Cognitive Functional Rating Scale

An observational study of Cognition and Parkinson's Disease, run by Gazi University at 2 sites in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The aim of the present study is to translate the Parkinson's Disease-Cognitive Functional Rating Scale into Turkish (PD-CFRS-Turkish version) and to evaluate its validity and reliability. Read more about this study

Who is it for?
Ages 40 years and older
How many people
60 participants
Where
2 sitesTurkey (Türkiye)
Study dates
10 Oct 2025to 10 Dec 2026
How long will I take part?
2 Weeks
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study has a multicenter design. The participating sites are as follows: Ankara Bilkent City Hospital, Physical Therapy and Rehabilitation Hospital- designated as Site 1. Participants at this site will include individuals diagnosed with Parkinson's disease (PD) who are currently receiving treatment at the hospital and have consented to participate in the study. Gazi University, Faculty of Health Sciences, Neurological Physical Therapy and Rehabilitation Unit - designated as Site 2. Participants at this site will include individuals diagnosed with PD who have been referred to the unit and have consented to participate in the study.

Who may be able to join

  • Clinically diagnosed with idiopathic Parkinson's disease by a neurologist.
  • Evaluated between Stage 1-3 according to the Hoehn and Yahr Staging Scale.
  • Aged 40 years or older.
  • Agreed to participate in the study after being given sufficient information.

Who cannot join

  • Patients with a Montreal Cognitive Assessment score of 20 and below.
  • Patients with cardiovascular, vestibular, musculoskeletal or additional neurological disease.

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

  • Gazi University, Faculty of Health Sciences

    Ankara, 06490

  • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Validity and Reliability Analysis of the Turkish Version of The Parkinson Disease Cognitive Functional Rating Scale

The aim of the present study is to translate the Parkinson's Disease-Cognitive Functional Rating Scale into Turkish (PD-CFRS-Turkish version) and to evaluate its validity and reliability.

Read the detailed description

The Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS) is one of the Parkinson's disease-specific instruments developed to assess a broad range of functional impairments resulting from cognitive deficits in individuals with Parkinson's disease (PD). The PD-CFRS is specifically designed to evaluate cognitive dysfunction while minimizing the confounding effects of motor symptoms.

The scale consists of 12 items that assess whether the patient experiences difficulties in performing activities such as managing money and household finances, arranging vacations or meetings, handling personal correspondence, checking medication schedules, organizing daily routines, using electrical appliances, understanding public transportation, dealing with unforeseen situations, expressing intentions, comprehending written information, and using a mobile phone.

Each item is rated on a 3-point scale ranging from 0 to 2. If the participant has never performed the activity in question, a score of 8 is assigned. At the end of the assessment, the average score for items rated between 0 and 2 is calculated and rounded to the nearest whole number. This value replaces all items initially scored as 8. Once all substituted scores are assigned, the total score is obtained by summing all item scores. The administration time for the scale is approximately 5 minutes.

Keywords
Parkinson's disease, Cognition, Cognitive Functions, 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.

Study groups in NCT07253376
Study groupRoleWhat they receive
Individuals with Parkinson's DiseaseParticipants diagnosed with Parkinson's disease who will complete the Turkish version of the Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS) for validity and reliability analysis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validity of the Turkish Version of the Parkinson's Disease Cognitive Functional Rating Scale

    Parkinson's Disease Cognitive Functional Rating Scale assesses the functional impact of cognitive impairment in individuals with Parkinson's disease. The 12-item scale assesses cognitive impairment while minimizing motor effects. Items are scored 0-2. Unperformed tasks (score 8) are replaced by the average of scored items and summed. The total score ranges from 0 to 24. Higher scores indicate worse outcomes.

    The validity of the Turkish version of the scale will be evaluated through convergent and discriminant construct analyses. Convergent validity will be assessed by examining partial Pearson correlations between Parkinson's Disease Cognitive Functional Rating Scale scores and Mini-Mental State Examination and Montreal Cognitive Assessment scores.

    Discriminant validity will be analyzed using binary logistic regression with Mini-Mental State Examination and Montreal Cognitive Assessment scores and disease duration as independent variables.

    Measured: Baseline

Secondary outcomes (6)

  1. Reliability of the Turkish Version of the Parkinson's Disease Cognitive Functional Rating Scale

    The 12-item Parkinson's Disease Cognitive Functional Rating Scale assesses cognitive impairment while minimizing motor effects. Items are scored 0-2. Unperformed tasks (score 8) are replaced by the average of scored items and summed. The total score ranges from 0 to 24. Higher scores indicate worse outcomes.

    Test-retest reliability will be assessed by repeating the PD-CFRS administration after a two-week interval by the same examiner. The scale evaluates participants' cognitive skills over the previous two weeks. Reliability will be calculated using the Intraclass Correlation Coefficient (ICC).

    Measured: Repeated measurements will be conducted at a 2 week interval.

  2. Mini Mental State Examination Score

    Assessment of general cognitive function, including attention, orientation, memory, verbal responses, following verbal and written commands, sentence writing, and copying complex figures. The Mini-Mental State Examination is scored from 0 to 30, with a cutoff score of 24. Higher scores reflect better cognitive function, while scores below 24 suggest cognitive impairment. The score obtained from the test will be recorded.

    Measured: Baseline

  3. Montreal Cognitive Assessment Score

    Montreal Cognitive Assessment, which provides a general cognitive screening in different cognitive functions such as attention, concentration, executive functions, memory, language, visual structuring skills, abstract thought, calculation and orientation, will be used in the general evaluation of cognition. MoCA is an effective scale especially in the evaluation of mild cognitive impairments in Parkinson's disease. The cut-off score range of Montreal Cognitive Assessment has been shown to be 18-26 points in individuals with Parkinson's disease who has mild cognitive impairment. The administration of Montreal Cognitive Assessment takes approximately 10 minutes. The highest total score that can be obtained from the test is 30. Accordingly, a score of 21 points and above is considered normal. The score obtained from the test will be recorded.

    Measured: Baseline

  4. MDS-Unified Parkinson's Disease Rating Scale Part 3: Motor Examination Score

    Movement Disorders Society Unified Parkinson's Disease Rating Scale consists of 4 parts, like the classic Unified Parkinson's Disease Rating Scale. The severity of the patients' motor symptoms will be assessed using the Motor Examination part, which is the 3rd part of the MDS-Unified Parkinson's Disease Rating Scale. MDS-Unified Parkinson's Disease Rating Scale Part 3 consists of 18 items. All items in the scale are scored between 0 (Normal) and 4 (Severe) points. The score obtained from the test will be recorded.

    Measured: Baseline

  5. Hoehn and Yahr Scale

    The Hoehn and Yahr scale is a widely used clinical rating system that classifies the progression of Parkinson's disease into stages 1 through 5, primarily based on motor function, balance, and independence. It ranges from unilateral, mild symptoms (Stage 1) to being wheelchair-bound or bedridden (Stage 5). Higher scores reflect worse outcome.

    Measured: Baseline

  6. Hospital Anxiety and Depression Scale Scores

    The Hospital Anxiety and Depression Scale is a 14-item, self-administered questionnaire used to identify anxiety and depression in clinical settings. It consists of two subscales, 7 items each for anxiety and depression, focusing on cognitive and emotional symptoms while excluding physical symptoms, scoring 0-21 per scale. Each item is scored 0-3, with maximum subscale scores of 21. Higher scores indicate greater severity.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start10 Oct 2025
  3. Primary completion10 Oct 2026 (estimated)
  4. Study completion10 Dec 2026 (estimated)

Resources

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
60 participants (estimated)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07253376
Sponsor's protocol ID
TABED 1-25-1618
Status last verified
Mar 2026
First submitted
19 Nov 2025
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

    PubMed 12914662

  • Ozdilek B, Kenangil G. Validation of the Turkish Version of the Montreal Cognitive Assessment Scale (MoCA-TR) in patients with Parkinson's disease. Clin Neuropsychol. 2014;28(2):333-43. doi: 10.1080/13854046.2014.881554. Epub 2014 Feb 17.

    PubMed 24528299

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019

  • Kulisevsky J, Fernandez de Bobadilla R, Pagonabarraga J, Martinez-Horta S, Campolongo A, Garcia-Sanchez C, Pascual-Sedano B, Ribosa-Nogue R, Villa-Bonomo C. Measuring functional impact of cognitive impairment: validation of the Parkinson's disease cognitive functional rating scale. Parkinsonism Relat Disord. 2013 Sep;19(9):812-7. doi: 10.1016/j.parkreldis.2013.05.007. Epub 2013 Jun 15.

    PubMed 23773412

  • Kline, P. (1994). An Easy Guide to Factor Analysis (1st ed.). Routledge.

  • Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available.

    PubMed 6067254

  • Aydemir O, Kirpinar I, Sati T, Uykur B, Cengisiz C. Reliability and Validity of the Turkish Version of the Health Anxiety Inventory. Noro Psikiyatr Ars. 2013 Dec;50(4):325-331. doi: 10.4274/npa.y6383. Epub 2013 Dec 1.

    PubMed 28360565

  • Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.

    PubMed 12794644

  • Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n.

    PubMed 8263569

  • Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

    PubMed 19025984

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.

    PubMed 11832252

Questions about this trial

What is this clinical trial studying?

An observational study of Cognition and Parkinson's Disease, run by Gazi 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 2 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: enrolling by invitation, as of the sponsor's last update on 19 Mar 2026. 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?

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?

Validity of the Turkish Version of the Parkinson's Disease Cognitive Functional Rating Scale (time frame: Baseline). 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 NCT07253376, which also lists 13 linked publications.

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 Mar 2026.

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