The Natural History of Parkinson's Disease-associated Spinal Disorders

NCT ID: NCT04101513

Last Updated: 2023-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-14

Study Completion Date

2027-02-14

Brief Summary

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This is a prospective single-institution longitudinal study to access quality of life and serial imaging and biodynamic testing to assess spinal disorders associated with Parkinson's disease patients.

Detailed Description

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This is a prospective single-institution longitudinal study to access quality of life with PROMIS testing, ODI, NDI, VAS and short form 36 health physical component score. The study will also include serial radiographic assessments and biodynamic force plate and hand dynamometer testing. This study will follow for five years post-consent.

Conditions

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Parkinson Disease Idiopathic Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Idiopathic Parkinson Disease Early to mid-disease course (Hoehn and Yahr scale 1-3) Age 18-75

Exclusion Criteria

* Prior spinal fusion Diagnosis of ankylosing spondylitis, diffuse idiopathic spinal hyperostosis (DISH), or other systemic condition that affects spinal function Inability to consent Current incarceration Presence of other medical condition or neurologic condition that would hinder ability to perform biodynamic testing
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Grossbach

Associate Attending

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Grossbach, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2018H0580

Identifier Type: -

Identifier Source: org_study_id

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