Bradykinesia Subscale Administered Alone Versus Regular Administration: Psychometric Properties

Parkinson's Disease Clinical Trial

— Bravura  

Official title:

Investigation of the Psychometric Properties of the Bradykinesia Subscale When Administered Alone Versus as a Component of the Entire Motor Examination Section of the Unified Parkinson's Disease Rating Scale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932581
• Other study ID #: PM105
• Status: Completed
• Start date: June 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2023
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine whether scores on questionnaires that rate how much Parkinson's Disease (PD) has slowed movements of the body differ when the order of the questions are changed. The consistency and accuracy of the questionnaires will also be examined. It is hypothesized that there will not be a difference.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

1. Male or Female at least 30 years of age

2. Willing to be assessed using the motor examination section of the UPDRS and the SPES/SCOPA motor evaluation

3. Patients must be willing and able to give written informed consent prior to performing an study procedures

4. Be in the "ON" State (only for patients who fluctuate between "ON" and "OFF" states)

Exclusion Criteria:

1. Absence of bradykinesia at the time of assessment

2. Hoehn and Yahr stage not available from patient's chart or not assessed between 3 and 180 days prior to clinic visit

3. Has received and experimental drug within the last thirty (30) days

Related Conditions & MeSH terms

• Hypokinesia
• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Bradykinesia UPDRS Motor Full Examination
The first group will receive the full motor examination section in its original order.
• Bradykinesia subscale of UPDRS Motor Examination
The second group will receive the bradykinesia subscale first followed by the remainder of the motor examination section.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on the UPDRS motor evaluation subscale are equivalent.		4 months
Secondary	Correlations between the UPDRS motor examination bradykinesis subscale and the remaining UPDRS motor examination items, Hoeh and Yahr stage, Schwab and England scale, and SPES/SCOPA motor evaluation.		4 months