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Bradykinesia Subscale Administered Alone Versus Regular Administration: Psychometric Properties (Bravura)

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00932581
First received: July 1, 2009
Last updated: November 1, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
 Other: Bradykinesia UPDRS Motor Full Examination
Other: Bradykinesia subscale of UPDRS Motor Examination
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Scores on the UPDRS motor evaluation subscale are equivalent. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Full Exam
The first group will receive the full motor examination section in its original order.
 Other: Bradykinesia UPDRS Motor Full Examination
The first group will receive the full motor examination section in its original order.
Other Name: Experimental group
Subscale
The second group will receive the bradykinesia subscale first followed by the remainder of the motor examination section.
 Other: Bradykinesia subscale of UPDRS Motor Examination
The second group will receive the bradykinesia subscale first followed by the remainder of the motor examination section.
Other Name: Subscale 1, Bradykinesia subscale

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of idiopathic Parkinsons disease (PD) who also presented with bradykinesia and one other cardinal sign at the time of assessment.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932581

Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Philip Buck, PhD, MPH Teva Neuroscience, Inc.
  More Information

No publications provided

Responsible Party: Linda Lintz, Clinical Trial Manager, Teva Neuroscience, Inc.
ClinicalTrials.gov Identifier: NCT00932581     History of Changes
Other Study ID Numbers: PM105
Study First Received: July 1, 2009
Last Updated: November 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceutical Industries:
Parkinson's Disease
Movement Disorders
Unified Parkinson's Disease Rating Scale
Short Parkinson's Evaluation Scale
Scales for Outcomes in Parkinson's Disease
Motor Evaluation
 Schwab and England activities of daily living
Bradykinesia
psychometrics
order effects
hoehn yahr aging
assessments

Additional relevant MeSH terms:
Parkinson Disease
Hypokinesia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013