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

NCT01092936 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2010-03-25

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Fondazione Neureca

    lead OTHER

Principal Investigators

  • Paolo Barone, Prof. · Universita' Federico II di Napoli

  • Maurizio Zibetti, Dr · Azienda Sanitaria Ospedaliera "San Giovanni Battista di Torino" Le Molinette

  • Angelo Antonini, Prof · Ospedale San Camillo IRCCS Venezia

  • Gianni Pezzoli, Prof · Istituti Clinici di Perfezionamento Milano

  • Michele Tinazzi, Prof · Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.Rossi

  • Giovanni Abbruzzese, Prof · Universita' di Genova

  • Ubaldo Bonuccelli, Prof · Universita' di Pisa

  • Giovanni Fabbrini, Dr · Universita' La Sapienza di Roma

  • Letterio Morgante, Prof · Azienda Ospedaliera Universitaria Policlinico G.Martino di Messina

  • Mario Zappia, Prof · Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele di Catania

  • Alberto Albanese, Prof · Istituto Neurologico Carlo Besta di Milano

  • Claudio Pacchetti · Istituto Neurologico Nazionale Fondazione IRCCS "C. Mondino" di Pavia

  • Aldo Quattrone, Prof · Policlinico Universitario Mater Domini di Catanzaro

  • Giovanni Cossu, Dr · Azienda Ospedaliera "G. Brotzu" di Cagliari

  • Aroldo Rossi, Prof · Universita' degli Studi di Perugia

  • Paolo Martinelli, Prof · Universita' di Bologna

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092936 on ClinicalTrials.gov