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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04101513

Enrollment

Registered

2019-09-24

Start date

2019-02-14

Completion date

2027-02-14

Last updated

2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Parkinson Disease, Parkinson Disease

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results