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

Fondazione Neureca

Status: Unknown

Conditions: Parkinson's Disease

Treatments: Other: Rating Scale administration

Study type: Observational

Funder types: Other

Identifiers

NCT01092936

IRIS

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.