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Development of an Instrumented System to Measure Mobility in Parkinson's Disease

NCT01174758 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2014-11-03

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • National Multiple Sclerosis Society

    collaborator OTHER

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Fay Horak, Phd · Oregon Health and Science University

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01174758 on ClinicalTrials.gov