Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale
NCT ID: NCT01092936
Last Updated: 2010-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
350 participants
OBSERVATIONAL
2010-03-31
2010-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Interventions
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Rating Scale administration
Movement Disorder Society\_Unified Parkinson's Disease Rating Scale will be submitted to the patient (with the help of the caregiver) in a single visit lasting about 40 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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 a degree of depression or dementia which may prevent and/or affect ratings.
18 Years
ALL
No
Sponsors
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Fondazione Neureca
OTHER
Responsible Party
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Fondazione NEURECA
Principal Investigators
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Paolo Barone, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universita' Federico II di Napoli
Maurizio Zibetti, Dr
Role: PRINCIPAL_INVESTIGATOR
Azienda Sanitaria Ospedaliera "San Giovanni Battista di Torino" Le Molinette
Angelo Antonini, Prof
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Camillo IRCCS Venezia
Gianni Pezzoli, Prof
Role: PRINCIPAL_INVESTIGATOR
Istituti Clinici di Perfezionamento Milano
Michele Tinazzi, Prof
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.Rossi
Giovanni Abbruzzese, Prof
Role: PRINCIPAL_INVESTIGATOR
Universita' di Genova
Ubaldo Bonuccelli, Prof
Role: PRINCIPAL_INVESTIGATOR
Universita' di Pisa
Giovanni Fabbrini, Dr
Role: PRINCIPAL_INVESTIGATOR
Universita' La Sapienza di Roma
Letterio Morgante, Prof
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria Policlinico G.Martino di Messina
Mario Zappia, Prof
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele di Catania
Alberto Albanese, Prof
Role: PRINCIPAL_INVESTIGATOR
Istituto Neurologico Carlo Besta di Milano
Claudio Pacchetti
Role: PRINCIPAL_INVESTIGATOR
Istituto Neurologico Nazionale Fondazione IRCCS "C. Mondino" di Pavia
Aldo Quattrone, Prof
Role: PRINCIPAL_INVESTIGATOR
Policlinico Universitario Mater Domini di Catanzaro
Giovanni Cossu, Dr
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera "G. Brotzu" di Cagliari
Aroldo Rossi, Prof
Role: PRINCIPAL_INVESTIGATOR
Universita' degli Studi di Perugia
Paolo Martinelli, Prof
Role: PRINCIPAL_INVESTIGATOR
Universita' di Bologna
Locations
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Universita' Federico II di Napoli
Napoli, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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IRIS
Identifier Type: -
Identifier Source: org_study_id
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