Parkinson DiseaseNCT03307161
Osteopathic Manual Treatment Parkinson's Disease and Truncal Dystonia
A study testing osteopathic manual therapy in people with Parkinson Disease and Dystonia, run by New York Institute of Technology at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Dystonia, Autonomic Dysreflexia
- What is being tested?
- osteopathic manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parkinson's disease; able to stand for three minutes or more
Who cannot join
- severe dementia, moderate or severe hallucinations and psychosis; unable to stand for three minutes
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology
Old Westbury, New York, 11568
About this study
Official title: 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.
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.
- Conditions
- Parkinson Disease, Dystonia, Autonomic Dysreflexia
- Being tested
- osteopathic manual therapy
- Keywords
- manual therapy, heart rate
- Medical subject headings
- Parkinson Disease, Dystonia, Autonomic Dysreflexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manual therapyOther
Investigators board certified in osteopathic manual therapy will use their hands in a non-invasive manner to improve dystonia symptoms
| Study group | Role | What they receive |
|---|---|---|
| Parkinsons fwd posture manual treatment | Active comparator | Subject will receive the intervention, osteopathic manual treatment protocol. Receives: Other: osteopathic manual therapy |
| Parkinsons forward posture | No intervention | Subjects will receive counseling. |
| Parkinsons without forward posture | No intervention | Subjects will receive counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in posture
inches of forward head carriage
Measured: 8 weeks
change in heart rate variability
heart rate changes
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study startNov 2016
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayme Mancini, PhD DO, Principal investigator, NYIT col osteopathic medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307161
- Sponsor's protocol ID
- 1130
- Status last verified
- Sep 2021
- First submitted
- 6 Oct 2017
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manual Treatment of Postural Abnormality, Pain, and Autonomic Control of Cardiac Function in People With Parkinson's Disease and Truncal Dystonia
- ClinicalTrials.gov ID
- NCT03307161
- Acronym / sponsor ID
- 1130
- Conditions
- Parkinson Disease, Dystonia, Autonomic Dysreflexia
- Keywords
- manual therapy, heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinsons fwd posture manual treatment | Active comparator | Other: osteopathic manual therapySubject will receive the intervention, osteopathic manual treatment protocol. |
| Parkinsons forward posture | No intervention | –Subjects will receive counseling. |
| Parkinsons without forward posture | No intervention | –Subjects will receive counseling. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parkinson's disease; able to stand for three minutes or more
Key exclusion criteria (1 listed)
- severe dementia, moderate or severe hallucinations and psychosis; unable to stand for three minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osteopathic manual therapyInvestigators board certified in osteopathic manual therapy will use their hands in a non-invasive manner to improve dystonia symptoms | Other | Parkinsons fwd posture manual treatment |
Primary outcome
change in posture
Time frame: 8 weeks
inches of forward head carriage
change in heart rate variability
Time frame: 8 weeks
heart rate changes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayme Mancini, PhD DO principal investigator
NYIT col osteopathic medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathic manual therapy in people with Parkinson Disease and Dystonia, run by New York Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in posture (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.