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

March 24, 2010 updated by: Fondazione Neureca

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Universita' Federico II di Napoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Native Italian-speaking PD patients ranging from mild to severe

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 6 months
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.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Neureca

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

March 25, 2010

Last Update Submitted That Met QC Criteria

March 24, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRIS (Other Identifier: Alias Study Number)

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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