NCT07253376

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Oct 2025

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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 Progress49%
Oct 2025Dec 2026

Study Start

First participant enrolled

October 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

November 19, 2025

Last Update Submit

March 17, 2026

Conditions

Keywords

Parkinson's diseaseCognitionCognitive FunctionsReliabilityValidity

Outcome Measures

Primary Outcomes (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.

    Baseline

Secondary Outcomes (6)

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

    Repeated measurements will be conducted at a 2 week interval.

  • Mini Mental State Examination Score

    Baseline

  • Montreal Cognitive Assessment Score

    Baseline

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

    Baseline

  • Hoehn and Yahr Scale

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

Individuals with Parkinson's Disease

Participants 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.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gazi University, Faculty of Health Sciences

Ankara, 06490, Turkey (Türkiye)

Location

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (13)

  • 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.

    PMID: 6880820BACKGROUND
  • Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

    PMID: 12914662BACKGROUND
  • 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.

    PMID: 24528299BACKGROUND
  • 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.

    PMID: 15817019BACKGROUND
  • 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.

    PMID: 23773412BACKGROUND
  • Kline, P. (1994). An Easy Guide to Factor Analysis (1st ed.). Routledge.

    BACKGROUND
  • 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.

    PMID: 6067254BACKGROUND
  • Aydemir Ö,Kirpinar İ,Sati T,Uykur B,Cengisiz C

    BACKGROUND
  • 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.

    PMID: 12794644BACKGROUND
  • 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.

    PMID: 8263569BACKGROUND
  • 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.

    PMID: 19025984BACKGROUND
  • 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.

    PMID: 1202204BACKGROUND
  • 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.

    PMID: 11832252BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Emre Adıgüzel, Prof., MD.

    Ankara City Hospital Bilkent

    STUDY DIRECTOR
  • Arzu Güçlü Gündüz, Prof., PT.

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, PT

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

October 10, 2025

Primary Completion (Estimated)

October 10, 2026

Study Completion (Estimated)

December 10, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations