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

May 10, 2023 updated by: Andrew Grossbach, Ohio State University
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.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Parkinson's patients in their early to mid-disease state. (Hoehn and Yahr scale 1-3) Age 18-75 years

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Natural history of spine disorders in idiopathic Parkinson's disease
Time Frame: Consent to five years
Natural history of spine disorders in idiopathic Parkinson's disease
Consent to five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical impact of Parkinson's related spinal disorders
Time Frame: Consent to five years
Clinical impact of Parkinson's related spinal disorders assessed by radiographic imaging and biodynamic testing
Consent to five years
Factors associated with the development and progression of Parkinson's related spinal disorders
Time Frame: consent to five years
Factors associated with the development and progression of Parkinson's related spinal disorders by assessing patients reported outcomes
consent to five years
Parameters for optimal management
Time Frame: consent to five years
Parameters for optimal management will be assessed by imaging and patient's medical records
consent to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Andrew Grossbach, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2019

Primary Completion (Anticipated)

February 14, 2025

Study Completion (Anticipated)

February 14, 2027

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018H0580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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