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
Recruitment status was Not yet recruiting
Sponsor:
Fondazione Neureca
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
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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
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
| 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 May 19, 2013