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CompletedNCT03307161Updated Sep 23, 2021

Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia

An interventional study of osteopathic manual therapy in Parkinson Disease, Dystonia and Autonomic Dysreflexia, sponsored by New York Institute of Technology. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-09-23.

Sponsored by New York Institute of Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Parkinson Disease
  • Dystonia
  • Autonomic Dysreflexia

Keywords

  • manual therapy
  • heart rate
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • severe dementia, moderate or severe hallucinations and psychosis; unable to stand for three minutes
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    Parkinsons fwd posture manual treatment

    Subject will receive the intervention, osteopathic manual treatment protocol.

    Other: osteopathic manual therapy

  • No intervention
    Parkinsons forward posture

    Subjects will receive counseling.

  • No intervention
    Parkinsons without forward posture

    Subjects will receive counseling.

Interventions

  • Otherosteopathic manual therapy

    Investigators board certified in osteopathic manual therapy will use their hands in a non-invasive manner to improve dystonia symptoms

05

What researchers measure

Primary outcomes

  1. change in posture

    inches of forward head carriage

    Time frame: 8 weeks

  2. change in heart rate variability

    heart rate changes

    Time frame: 8 weeks

06

Study locations

1 site
  • New York Institute of Technology
    Old Westbury, New York 11568, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03307161
Lead sponsor
New York Institute of Technology
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Nov 2016
Primary completion
Sep 20, 2021
Completion
Sep 20, 2021
Last update
Sep 23, 2021

Study contacts

Jayme Mancini, PhD DO
principal investigator · NYIT col osteopathic medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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