Clinical trial NCT01092936: Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale
Official title: Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Comparative fit index
Movement Disorders' Society
Unified Parkinson's Disease Rating Scale
Lead sponsor: Fondazione Neureca
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Native Italian-speaking PD patients ranging from mild to severe

Brief summary: The present study is part of an international program and deals with the translation and validation program for the Italian version of the MDS-UPDRS.

The program will be articulated in three steps:

* Phase I: translation and back-translation of the MDS-UPDRS in Italian (completed)
* Phase II: Cognitive testing. This step is aimed at a preliminary testing of a subset of potentially culturally sensitive items in a limited set of PD patients (approximately 10). Should this phase identify issues in the understanding and ease of use of some items a revised translation of some individual items might be envisaged.
* Phase III: large validation testing: this phase will involve 350 PD patients from 12-14 Italian PD centres.

The IRIS protocol deals with phase II and III of the program.


Eligibility criteria: Inclusion Criteria:

* Written and signed informed consent;
* native Italian-speaking patients or either sex;
* patients suffering from Parkinson's disease ranging from mild to severe, based on clinical judgement;
* presence of a native Italian-speaking caregiver.

Exclusion Criteria:

* Patients with evidence of other central nervous system disorders;
* patients with a degree of depression or dementia which may prevent and/or affect ratings.

Primary outcomes:
measure: Phase II: To test the appropriateness of the Italian translation and clear understanding of potentially cultural-sensitive items. To refine the translation, if necessary, prior to validation testing.
timeFrame: 6 months
measure: Phase III: the primary outcome of phase III is to confirm factorial analysis of the Italian version against the factor structure of the English version, by each of the four sections of the scale.
timeFrame: 6 months
Secondary outcomes:
measure: The secondary outcome is to determine the Differential Item Function (DIF) which will be run on items by gender, race , disease severity, education and age.
timeFrame: 6 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Universita' Federico II di Napoli
Study officials:
affiliation: Universita' Federico II di Napoli
name: Paolo Barone, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Sanitaria Ospedaliera "San Giovanni Battista di Torino" Le Molinette
name: Maurizio Zibetti, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale San Camillo IRCCS Venezia
name: Angelo Antonini, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituti Clinici di Perfezionamento Milano
name: Gianni Pezzoli, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.Rossi
name: Michele Tinazzi, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita' di Genova
name: Giovanni Abbruzzese, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita' di Pisa
name: Ubaldo Bonuccelli, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita' La Sapienza di Roma
name: Giovanni Fabbrini, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria Policlinico G.Martino di Messina
name: Letterio Morgante, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele di Catania
name: Mario Zappia, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Neurologico Carlo Besta di Milano
name: Alberto Albanese, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Neurologico Nazionale Fondazione IRCCS "C. Mondino" di Pavia
name: Claudio Pacchetti
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Universitario Mater Domini di Catanzaro
name: Aldo Quattrone, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera "G. Brotzu" di Cagliari
name: Giovanni Cossu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita' degli Studi di Perugia
name: Aroldo Rossi, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita' di Bologna
name: Paolo Martinelli, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: S. Fahn et al: The Unified Rating Scale for Parkinsonism. In Fahn, Marsden, Jenner, Teychenne eds.: Recent Developments in Parkinson's disease. N.J. Macmillan Healthcare Information: 153-63, 1987
citation: Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. The Unified Parkinson's Disease Rating Scale (UPDRS): status and recommendations. Mov Disord. 2003 Jul;18(7):738-50. doi: 10.1002/mds.10473.
citation: Goetz CG, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stebbins GT, Stern MB, Tilley BC, 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-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan. Mov Disord. 2007 Jan;22(1):41-7. doi: 10.1002/mds.21198.
citation: 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.
citation: Pagonabarraga J, Kulisevsky J, Llebaria G, Garcia-Sanchez C, Pascual-Sedano B, Gironell A. Parkinson's disease-cognitive rating scale: a new cognitive scale specific for Parkinson's disease. Mov Disord. 2008 May 15;23(7):998-1005. doi: 10.1002/mds.22007.