- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07253376
Turkish Validation of the Parkinson Disease Cognitive Functional Rating Scale
Validity and Reliability Analysis of the Turkish Version of The Parkinson Disease Cognitive Functional Rating Scale
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06490
- Gazi University, Faculty of Health Sciences
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Ankara, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with a Montreal Cognitive Assessment score of 20 and below.
- Patients with cardiovascular, vestibular, musculoskeletal or additional neurological disease.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Validity of the Turkish Version of the Parkinson's Disease Cognitive Functional Rating Scale
Time Frame: Baseline
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Reliability of the Turkish Version of the Parkinson's Disease Cognitive Functional Rating Scale
Time Frame: Repeated measurements will be conducted at a 2 week interval.
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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). |
Repeated measurements will be conducted at a 2 week interval.
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Mini Mental State Examination Score
Time Frame: Baseline
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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.
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Baseline
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Montreal Cognitive Assessment Score
Time Frame: Baseline
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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.
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Baseline
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MDS-Unified Parkinson's Disease Rating Scale Part 3: Motor Examination Score
Time Frame: Baseline
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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.
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Baseline
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Hoehn and Yahr Scale
Time Frame: Baseline
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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.
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Baseline
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Hospital Anxiety and Depression Scale Scores
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Emre Adıgüzel, Prof., MD., Ankara City Hospital Bilkent
- Principal Investigator: Arzu Güçlü Gündüz, Prof., PT., Gazi University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Kline, P. (1994). An Easy Guide to Factor Analysis (1st ed.). Routledge.
- Aydemir Ö,Kirpinar İ,Sati T,Uykur B,Cengisiz C
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TABED 1-25-1618
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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