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

• Conditions: Parkinson's Disease

• Registration Number: NCT01092936
• Lead Sponsor: Fondazione Neureca

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-24
• Last Update Submitted: 2010-03-24
• Study First Posted: 2010-03-25
• Last Update Posted: 2010-03-25
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universita' Federico II di Napoli; 🇮🇹 Napoli, Italy