Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia

• Sponsor: New York Institute of Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT03307161
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 3
• Duration (Months): 58.6
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Dystonia; Autonomic Dysreflexia	Other: osteopathic manual therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Nov 1, 2016
• Actual Primary Completion Date: Sep 20, 2021
• Actual Study Completion Date: Sep 20, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. change in posture [8 weeks]

   inches of forward head carriage

2. change in heart rate variability [8 weeks]

   heart rate changes

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Institute of Technology	Old Westbury	New York	United States	11568

Sponsors and Collaborators

• New York Institute of Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New York Institute of Technology
• ClinicalTrials.gov Identifier: NCT03307161
• Other Study ID Numbers: 1130
• First Posted: Oct 11, 2017
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by New York Institute of Technology: manual therapy; heart rate
• Additional relevant MeSH terms: Parkinson Disease; Dystonia; Dystonic Disorders; Autonomic Dysreflexia

Study Results

No Results Posted as of Sep 23, 2021