Development of an Instrumented System to Measure Mobility in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Developing technology to increase efficiency and decrease cost of clinical trials. The
      longterm objective of this project is to use new technologies to sensitively measure,
      automatically analyze and efficiently manage clinical trial data for Parkinson's disease (PD)
      and other neurological disorders. This project will focus on developing objective measures of
      balance and gait because mobility disability and falls are so critical for quality of life in
      PD. Clinical movement disorders experts will team up with a local start-up business to
      develop, produce, and test a novel clinical balance and gait assessment tool, the
      instrumented Timed Up and Go Test (iTUG) for patients with Parkinson's disease. Balance and
      gait will be measured with wireless sensors worn on the wrists, ankles and trunk while
      patients stand up from a chair, walk, turn and return to sit on the chair. Accelerations and
      angular velocities from the sensors will be automatically transmitted, stored, analyzed, and
      displayed as Mobility Scores on a remote, centralized computer, along with other patient
      information important for clinical trials. Specifically, this proposal will 1) create a
      commercially-available, clinical trial system that includes completely wireless sensor
      technology, a custom-made, user-friendly, computer interface and efficient data management
      server; 2) develop a mobility score from many potential balance and gait measures and 3)
      compare the sensitivity of the iTUG compared to traditional clinical tests of balance to
      changes in PD due to antiparkinson medication. By providing a more sensitive, accurate, and
      comprehensive method to quickly test and analyze balance and gait, clinical trials to improve
      mobility in patients with Parkinson's disease and other neurological disorders will be
      significantly more effective and efficient. This will permit clinical trials in Parkinson's
      disease to be completed with fewer subjects, shorter duration, and less cost.The current
      project will accelerate the development of new therapies for Parkinson's disease.
    

Detailed description: 
      The specific aims of the study:

      Aim I. To create a novel, commercially-available system for mobility assessment in clinical
      trials for Parkinson's disease. We have already developed a laboratory prototype system for
      the iTUG test, but the computer interface, sensors, and data management system are too
      cumbersome for use in clinical trials. In this proposal, we will create a robust,
      user-friendly clinical system for the iTUG test using wireless inertial sensors and a new
      user interface developed by a Portland start-up company, Automated Parkinson's Disease
      Monitoring (APDM), headed by a co-investigator. This mobility measuring system will be
      integrated with a new centralized data management server also developed by APDM, Inc. to
      support automatic data analysis and data organization for multi-site clinical trials. The
      feasibility of the new, clinical system will then be vetted by using it in a busy Movement
      Disorders Clinic.

      Aim II. To develop an objective, composite iTUG mobility score. We recently demonstrated that
      iTUG metrics are more sensitive in distinguishing mobility performance between people just
      diagnosed with PD from age-matched controls than traditional clinical tests. In this
      proposal, we will develop a composite mobility score from the iTUG gait and postural
      parameters most responsive to severity of PD and to the change from the levodopa ON and OFF
      states. The composite score will be calculated using statistical models that optimize
      differences in performance between 75 subjects with PD in the ON and OFF levodopa state.

      Aim III. To prospectively determine the reliability, validity and responsiveness of the iTUG
      mobility score. We will perform a prospective study with 60 patients with PD that compares
      standard clinical measures of postural instability and gait difficulty mobility (PIGD items
      from the Unified Parkinson's Disease Rating Scale (UPDRS) and TUG stop-watch scores) with our
      new iTUG mobility score in the OFF and ON levodopa states. We hypothesize that the iTUG will
      have good test-retest reliability, be significantly correlated with standard clinical
      measures and fall history and be more responsive to dopaminergic state than current mobility
      tests used in clinical trials. This project will develop, produce, and test a novel clinical
      balance and gait assessment tool, the instrumented Timed Up and Go test (iTUG) using our new,
      wearable, inertial sensors and our new clinical trial data management server that
      automatically transmits, stores, and analyzes data collected with the iTUG. By automatically
      providing a more sensitive, accurate, and comprehensive method to test balance and gait,
      clinical trials to improve mobility in patients with Parkinson's disease and other
      neurological disorders will be significantly more effective and efficient.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Movement Disorders Clinic at OHSU in Portland Oregon.
      
Keywords: balance; mobility; ON/OFF Levodopa