Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale

NCT01092936 | Unknown DMC

• 1 other identifier: IRIS
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Comparative fit index; Movement Disorders' Society; Unified Parkinson's Disease Rating Scale

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (1)

• 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.

  6 months

Interventions

Rating Scale administration OTHER

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Native Italian-speaking PD patients ranging from mild to severe

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Neureca: lead

Study Sites (1)

Universita' Federico II di Napoli

Napoli, 80131, Italy

Location

Related Publications (5)

• 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

  BACKGROUND

• 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.

  PMID: 12815652 BACKGROUND

• 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.

  PMID: 17115387 BACKGROUND

• 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: 19025984 BACKGROUND

• 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.

  PMID: 18381647 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Paolo Barone, Prof.

  Universita' Federico II di Napoli

  PRINCIPAL INVESTIGATOR

• Maurizio Zibetti, Dr

  Azienda Sanitaria Ospedaliera "San Giovanni Battista di Torino" Le Molinette

  PRINCIPAL INVESTIGATOR

• Angelo Antonini, Prof

  Ospedale San Camillo IRCCS Venezia

  PRINCIPAL INVESTIGATOR

• Gianni Pezzoli, Prof

  Istituti Clinici di Perfezionamento Milano

  PRINCIPAL INVESTIGATOR

• Michele Tinazzi, Prof

  Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.Rossi

  PRINCIPAL INVESTIGATOR

• Giovanni Abbruzzese, Prof

  Universita' di Genova

  PRINCIPAL INVESTIGATOR

• Ubaldo Bonuccelli, Prof

  Universita' di Pisa

  PRINCIPAL INVESTIGATOR

• Giovanni Fabbrini, Dr

  Universita' La Sapienza di Roma

  PRINCIPAL INVESTIGATOR

• Letterio Morgante, Prof

  Azienda Ospedaliera Universitaria Policlinico G.Martino di Messina

  PRINCIPAL INVESTIGATOR

• Mario Zappia, Prof

  Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele di Catania

  PRINCIPAL INVESTIGATOR

• Alberto Albanese, Prof

  Istituto Neurologico Carlo Besta di Milano

  PRINCIPAL INVESTIGATOR

• Claudio Pacchetti

  Istituto Neurologico Nazionale Fondazione IRCCS "C. Mondino" di Pavia

  PRINCIPAL INVESTIGATOR

• Aldo Quattrone, Prof

  Policlinico Universitario Mater Domini di Catanzaro

  PRINCIPAL INVESTIGATOR

• Giovanni Cossu, Dr

  Azienda Ospedaliera "G. Brotzu" di Cagliari

  PRINCIPAL INVESTIGATOR

• Aroldo Rossi, Prof

  Universita' degli Studi di Perugia

  PRINCIPAL INVESTIGATOR

• Paolo Martinelli, Prof

  Universita' di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Campanella, Dr

CONTACT

+39 02 34535088; campanella@mcr-med.com

M.Cristina Jori, Dr.

CONTACT

+39 02 34535088; jori@mcr-med.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 25, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 25, 2010

Record last verified: 2010-03

Locations

IT (1)