(30 lines for public) This application addresses the broad Challenge Area (07): Enhancing Clinical Trials and specific Challenge Topic, 07-NS-101: Developing technology to increase efficiency and decrease cost of clinical trials. The long- term 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. This project will use new technology to develop objective instruments and centralized monitoring of balance and gait for Parkinson's disease and other neurological disorders. These new tools will permit clinical trials aimed at reducing mobility disability to be completed with fewer subjects, shorter duration, and less cost.

Public Health Relevance

This project will use new technology to develop objective instruments and centralized monitoring of balance and gait for Parkinson's disease and other neurological disorders. These new tools will permit clinical trials aimed at reducing mobility disability to be completed with fewer subjects, shorter duration, and less cost.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
NIH Challenge Grants and Partnerships Program (RC1)
Project #
1RC1NS068678-01
Application #
7832496
Study Section
Special Emphasis Panel (ZRG1-BBBP-L (58))
Program Officer
Sieber, Beth-Anne
Project Start
2009-09-30
Project End
2011-08-31
Budget Start
2009-09-30
Budget End
2010-08-31
Support Year
1
Fiscal Year
2009
Total Cost
$499,679
Indirect Cost
Name
Oregon Health and Science University
Department
Neurology
Type
Schools of Medicine
DUNS #
096997515
City
Portland
State
OR
Country
United States
Zip Code
97239
Bonora, Gianluca; Mancini, Martina; Carpinella, Ilaria et al. (2017) Gait initiation is impaired in subjects with Parkinson's disease in the OFF state: Evidence from the analysis of the anticipatory postural adjustments through wearable inertial sensors. Gait Posture 51:218-221
Horak, Fay B; Mancini, Martina; Carlson-Kuhta, Patricia et al. (2016) Balance and Gait Represent Independent Domains of Mobility in Parkinson Disease. Phys Ther 96:1364-71
Curtze, Carolin; Nutt, John G; Carlson-Kuhta, Patricia et al. (2016) Objective Gait and Balance Impairments Relate to Balance Confidence and Perceived Mobility in People With Parkinson Disease. Phys Ther 96:1734-1743
Baston, Chiara; Mancini, Martina; Rocchi, Laura et al. (2016) Effects of Levodopa on Postural Strategies in Parkinson's disease. Gait Posture 46:26-9
Mancini, Martina; Horak, Fay B (2016) Potential of APDM mobility lab for the monitoring of the progression of Parkinson's disease. Expert Rev Med Devices 13:455-62
Mancini, Martina; Chiari, Lorenzo; Holmstrom, Lars et al. (2016) Validity and reliability of an IMU-based method to detect APAs prior to gait initiation. Gait Posture 43:125-31
Curtze, Carolin; Nutt, John G; Carlson-Kuhta, Patricia et al. (2015) Levodopa Is a Double-Edged Sword for Balance and Gait in People With Parkinson's Disease. Mov Disord 30:1361-70
Horak, Fay B; Mancini, Martina (2013) Objective biomarkers of balance and gait for Parkinson's disease using body-worn sensors. Mov Disord 28:1544-51
Schoneburg, Bernadette; Mancini, Martina; Horak, Fay et al. (2013) Framework for understanding balance dysfunction in Parkinson's disease. Mov Disord 28:1474-82
Mancini, Martina; Priest, Kelsey C; Nutt, John G et al. (2012) Quantifying freezing of gait in Parkinson's disease during the instrumented timed up and go test. Conf Proc IEEE Eng Med Biol Soc 2012:1198-201

Showing the most recent 10 out of 15 publications