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

April 6, 2023 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • Subscale 1, Bradykinesia subscale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scores on the UPDRS motor evaluation subscale are equivalent.
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM105 (Gencell)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Bradykinesia UPDRS Motor Full Examination

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe