Back to resultsOsteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia
Primary Purpose
Parkinson Disease, Dystonia, Autonomic Dysreflexia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
osteopathic manual therapy
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring manual therapy, heart rate
Eligibility Criteria
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
Sites / Locations
- New York Institute of Technology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
No Intervention
Arm Label
Parkinsons fwd posture manual treatment
Parkinsons forward posture
Parkinsons without forward posture
Arm Description
Subject will receive the intervention, osteopathic manual treatment protocol.
Subjects will receive counseling.
Subjects will receive counseling.
Outcomes
Primary Outcome Measures
change in posture
inches of forward head carriage
change in heart rate variability
heart rate changes
Secondary Outcome Measures
Full Information
NCT ID
NCT03307161
First Posted
October 6, 2017
Last Updated
September 21, 2021
Sponsor
New York Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT03307161
Brief Title
Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia
Official Title
Osteopathic Manual Treatment of Postural Abnormality, Pain, and Autonomic Control of Cardiac Function in People With Parkinson's Disease and Truncal Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Institute of Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine if posture and heart rate variability will significantly improve in Parkinsons disease with camptocormia after osteopathic manual treatments dystonia.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Dystonia, Autonomic Dysreflexia
Keywords
manual therapy, heart rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parkinsons fwd posture manual treatment
Arm Type
Active Comparator
Arm Description
Subject will receive the intervention, osteopathic manual treatment protocol.
Arm Title
Parkinsons forward posture
Arm Type
No Intervention
Arm Description
Subjects will receive counseling.
Arm Title
Parkinsons without forward posture
Arm Type
No Intervention
Arm Description
Subjects will receive counseling.
Intervention Type
Other
Intervention Name(s)
osteopathic manual therapy
Intervention Description
Investigators board certified in osteopathic manual therapy will use their hands in a non-invasive manner to improve dystonia symptoms
Primary Outcome Measure Information:
Title
change in posture
Description
inches of forward head carriage
Time Frame
8 weeks
Title
change in heart rate variability
Description
heart rate changes
Time Frame
8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayme Mancini, PhD DO
Organizational Affiliation
NYIT col osteopathic medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Institute of Technology
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia
We'll reach out to this number within 24 hrs