NCT03307161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

4.9 years

First QC Date

October 6, 2017

Last Update Submit

September 21, 2021

Conditions

Parkinson DiseaseDystoniaAutonomic Dysreflexia

Keywords

manual therapyheart rate

Outcome Measures

Primary Outcomes (2)

  • change in posture

    inches of forward head carriage

    8 weeks

  • change in heart rate variability

    heart rate changes

    8 weeks

Study Arms (3)

Parkinsons fwd posture manual treatment

ACTIVE COMPARATOR

Subject will receive the intervention, osteopathic manual treatment protocol.

Other: osteopathic manual therapy

Parkinsons forward posture

NO INTERVENTION

Subjects will receive counseling.

Parkinsons without forward posture

NO INTERVENTION

Subjects will receive counseling.

Interventions

osteopathic manual therapyOTHER

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

Parkinsons fwd posture manual treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Institute of Technology

Old Westbury, New York, 11568, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseDystoniaAutonomic Dysreflexia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAutonomic Nervous System DiseasesSpinal Cord InjuriesTrauma, Nervous System

Study Officials

  • Jayme Mancini, PhD DO

    NYIT col osteopathic medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 11, 2017

Study Start

November 1, 2016

Primary Completion

September 20, 2021

Study Completion

September 20, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)