Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia

September 21, 2021 updated by: New York Institute of Technology

Osteopathic Manual Treatment of Postural Abnormality, Pain, and Autonomic Control of Cardiac Function in People With Parkinson's Disease and Truncal Dystonia

This study will determine if posture and heart rate variability will significantly improve in Parkinsons disease with camptocormia after osteopathic manual treatments dystonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will determine if posture and heart rate variability will significantly improve in Parkinsons disease with camptocormia after receiving 8-weekly sessions of the osteopathic manual treatments for truncal flexion dystonia as measured by the distance of the external acoustic meatus from a plumb-line to lateral malleolus, spinal X ray, and heart rate variability.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • Old Westbury, New York, United States, 11568
        • New York Institute of Technology

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parkinson's disease; able to stand for three minutes or more

Exclusion Criteria:

  • severe dementia, moderate or severe hallucinations and psychosis; unable to stand for three minutes

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Parkinsons fwd posture manual treatment
Subject will receive the intervention, osteopathic manual treatment protocol.
Other: osteopathic manual therapy
Investigators board certified in osteopathic manual therapy will use their hands in a non-invasive manner to improve dystonia symptoms
No Intervention: Parkinsons forward posture
Subjects will receive counseling.
No Intervention: Parkinsons without forward posture
Subjects will receive counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in posture
Time Frame: 8 weeks
inches of forward head carriage
8 weeks
change in heart rate variability
Time Frame: 8 weeks
heart rate changes
8 weeks

Collaborators and Investigators

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

Sponsor

New York Institute of Technology

Investigators

  • Principal Investigator: Jayme Mancini, PhD DO, NYIT col osteopathic medicine

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

November 1, 2016

Primary Completion (Actual)

September 20, 2021

Study Completion (Actual)

September 20, 2021

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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