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

Parkinson's Disease Clinical Trial

— IRIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01092936
• Other study ID #: IRIS
• Status: Not yet recruiting
• Phase: N/A
• First received: March 24, 2010
• Last updated: March 24, 2010
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Fondazione Neureca
• Contact: Silvia Campanella, Dr
• Phone: +39 02 34535088
• Email: campanella[@]mcr-med.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
Italy	Universita' Federico II di Napoli	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Neureca

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Goetz CG, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stebbins GT, Stern MB, Tilley BC, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, Van Hilten JJ, LaPelle N. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan. Mov Disord. 2007 Jan;22(1):41-7. — View Citation

Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340. — View Citation

Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. The Unified Parkinson's Disease Rating Scale (UPDRS): status and recommendations. Mov Disord. 2003 Jul;18(7):738-50. Review. — View Citation

Pagonabarraga J, Kulisevsky J, Llebaria G, García-Sánchez C, Pascual-Sedano B, Gironell A. Parkinson's disease-cognitive rating scale: a new cognitive scale specific for Parkinson's disease. Mov Disord. 2008 May 15;23(7):998-1005. doi: 10.1002/mds.22007. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No

External Links

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