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

NCT01174758 | Completed

• 1 other identifier: 5029
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Parkinson's Disease

Keywords

balance; mobility; ON/OFF Levodopa

Outcome Measures

Primary Outcomes (1)

• iMOBILITY: the instrumented system for measuring mobility.

  Instrumented system for measuring mobility. Which measures over a 100 different variables of movement, for example: Cadence, Turning Duration, Turning Velocity etc...

  2 years

Study Arms (1)

Parkinson's disease

Individuals participating in the study have been diagnosed with idiopathic Parkinson's disease.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Movement Disorders Clinic at OHSU in Portland Oregon.

You may qualify if:

• Diagnosis of idiopathic Parkinson's Disease
• Ages 50-80
• Currently taking some form of Carbidopa/Levodopa

You may not qualify if:

• Significant orthopedic injuries or surgeries
• Deep-Brain-Stimulation surgery
• Any other neurological conditions

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Oregon Clinical Translational Research Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Fay Horak, Phd

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 4, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 3, 2014

Record last verified: 2014-10

Locations

US (1)