Bradykinesia Subscale Administered Alone Versus Regular Administration: Psychometric Properties - Full Text View

Sponsors and Collaborators:	Teva Pharmaceutical Industries EMB Statistical Solutions, LLC
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00932581

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 IV

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment
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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

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 ]

Estimated Enrollment:	110
Study Start Date:	June 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Full Exam: Active Comparator 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.
Subscale: Experimental 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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or Female at least 30 years of age
Willing to be assessed using the motor examination section of the UPDRS and the SPES/SCOPA motor evaluation
Patients must be willing and able to give written informed consent prior to performing an study procedures
Be in the "ON" State (only for patients who fluctuate between "ON" and "OFF" states)

Exclusion Criteria:

Absence of bradykinesia at the time of assessment
Hoehn and Yahr stage not available from patient's chart or not assessed between 3 and 180 days prior to clinic visit
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

Locations

United States, Tennessee
Brentwood Neurology
Brentwood, Tennessee, United States, 37027

Sponsors and Collaborators

Teva Pharmaceutical Industries

EMB Statistical Solutions, LLC

Investigators

Study Director:

Philip Buck, PhD, MPH

Teva Neuroscience, Inc.

More Information

No publications provided

Responsible Party:	Teva Neuroscience, Inc. ( Linida Lintz, Clinical Trial Manager )
Study ID Numbers:	PM105
Study First Received:	July 1, 2009
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00932581 History of Changes
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

Study placed in the following topic categories:

Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Bradykinesia

Signs and Symptoms
Parkinson Disease
Movement Disorders
Neurologic Manifestations
Parkinsonian Disorders
Hypokinesia

Additional relevant MeSH terms:

Signs and Symptoms
Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases
Neurologic Manifestations

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Hypokinesia
Dyskinesias

ClinicalTrials.gov processed this record on September 10, 2009