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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Fondazione Neureca.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Fondazione Neureca
ClinicalTrials.gov Identifier:
NCT01092936
First received: March 24, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Parkinson's Disease
Other: Rating Scale administration

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale

Resource links provided by NLM:


Further study details as provided by Fondazione Neureca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: March 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Native Italian-speaking PD patients ranging from mild to severe

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092936

Contacts
Contact: Silvia Campanella, Dr +39 02 34535088 ext 31 campanella@mcr-med.com
Contact: M.Cristina Jori, Dr. +39 02 34535088 ext 23 jori@mcr-med.com

Locations
Italy
Universita' Federico II di Napoli Not yet recruiting
Napoli, Italy, 80131
Contact: Paolo Barone, Prof.    +39 081 7462670    barone@unina.it   
Principal Investigator: Paolo Barone, Prof.         
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
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. Movement Disorders Vol. 18, No 7, 2003, pp. 738-750

Responsible Party: Dr. Linda Toscano, Fondazione NEURECA
ClinicalTrials.gov Identifier: NCT01092936     History of Changes
Other Study ID Numbers: IRIS
Study First Received: March 24, 2010
Last Updated: March 24, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Neureca:
Comparative fit index
Movement Disorders' Society
Unified Parkinson's Disease Rating Scale

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 26, 2014