Parkinson's DiseaseBravuraNCT00932581
Bradykinesia Subscale Administered Alone Versus Regular Administration: Psychometric Properties
An observational study of Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc..
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Bradykinesia UPDRS Motor Full Examination and Bradykinesia subscale of UPDRS Motor Examination
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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
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.
- Conditions
- Parkinson's Disease
- Being tested
- Bradykinesia UPDRS Motor Full Examination, Bradykinesia subscale of UPDRS Motor Examination
- Keywords
- 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
- Medical subject headings
- Parkinson Disease, Movement Disorders, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bradykinesia UPDRS Motor Full ExaminationOther
Also called Experimental group
The first group will receive the full motor examination section in its original order.
Bradykinesia subscale of UPDRS Motor ExaminationOther
Also called Subscale 1, Bradykinesia subscale
The second group will receive the bradykinesia subscale first followed by the remainder of the motor examination section.
| Study group | Role | What they receive |
|---|---|---|
| Full Exam | The first group will receive the full motor examination section in its original order. Receives: Other: Bradykinesia UPDRS Motor Full Examination | |
| Subscale | The second group will receive the bradykinesia subscale first followed by the remainder of the motor examination section. Receives: Other: Bradykinesia subscale of UPDRS Motor Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the UPDRS motor evaluation subscale are equivalent.
Measured: 4 months
Secondary outcomes (1)
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip Buck, PhD, MPH, Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932581
- Sponsor's protocol ID
- PM105
- Acronym
- Bravura
- Status last verified
- Apr 2023
- First submitted
- 1 Jul 2009
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00932581
- Acronym / sponsor ID
- Bravura / PM105
- Conditions
- Parkinson's Disease
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Exam | – | Other: Bradykinesia UPDRS Motor Full ExaminationThe first group will receive the full motor examination section in its original order. |
| Subscale | – | Other: Bradykinesia subscale of UPDRS Motor ExaminationThe second group will receive the bradykinesia subscale first followed by the remainder of the motor examination section. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bradykinesia UPDRS Motor Full ExaminationAlso: Experimental groupThe first group will receive the full motor examination section in its original order. | Other | Full Exam |
| Bradykinesia subscale of UPDRS Motor ExaminationAlso: Subscale 1, Bradykinesia subscaleThe second group will receive the bradykinesia subscale first followed by the remainder of the motor examination section. | Other | Subscale |
Primary outcome
Scores on the UPDRS motor evaluation subscale are equivalent.
Time frame: 4 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Buck, PhD, MPH study director
Teva Neuroscience, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Teva Branded Pharmaceutical Products R&D, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on the UPDRS motor evaluation subscale are equivalent. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023; AzTrials last refreshed its copy on 31 Oct 2026.