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Parkinson DiseaseNCT02107638

Effect of Osteopathic Manipulative Medicine on Parkinson Disease

A study testing OMM treatment arm and Counseling in people with Parkinson Disease, run by New York Institute of Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Parkinson's disease (PD) is defined as a progressive disorder of the nervous system that affects the patient's mobility, balance and cognition. Tremor, slowed movements, and rigidity are physical symptoms which contribute to postural and gait abnormalities seen in many PD patients. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
OMM treatment arm and Counseling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
15 Apr 2014to Apr 2023
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Medically diagnosed with Parkinson's Disease
  • Over the age of 40

Who cannot join

  • no clinical diagnosis of Parkinson's Disease
  • having other diagnosed neurological diseases or disorders
  • being completely wheelchair bound or having physical deformities that would prevent completion of the assessment tools

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York Institute of Technology - Academic Health Care Center

    Old Westbury, New York, 11568

Other trials in United States

About this study

Official title: Effect of Osteopathic Manipulative Medicine on Motor Function, Balance, and Neuroprotective Serum Markers in Parkinson Disease

Parkinson's disease (PD) is defined as a progressive disorder of the nervous system that affects the patient's mobility, balance and cognition. Tremor, slowed movements, and rigidity are physical symptoms which contribute to postural and gait abnormalities seen in many PD patients. Other symptoms include loss of balance and restricted range of motion, increasing the risk of falling. Osteopathic manipulative medicine (OMM) is a form of manual treatment provided by osteopathic physicians. This form of treatment aims to help decrease muscle spasms and improve joint range of motion and movement. We are proposing a pilot study to investigate the impact of OMM on balance, motor function, and falling in PD patients. We are also going to screen for serum biomarker changes to investigate the potential effects of OMM. Our research team and institution have experience in providing osteopathic care and physical rehabilitation for PD patients. In this study, balance and motor function will be evaluated for each subject throughout the study period. We will also keep track of the number of falls. Balance will be measured using Sensory Organization Test (SOT) and motor function will be measured using Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Both tools are non-invasive and clinically proven methods for measuring balance and motor function.

Read the detailed description

Annually, 60,000 people within the United States are diagnosed with PD.1 The cardinal features of PD include resting tremor, rigidity, asymmetric onset, and bradykinesia.2 These characteristics appear to affect balance. Balance is a complex system that involves maintaining posture, facilitating movement, and recovering equilibrium to control one's body within its limits of stability. Balance involves the coordination of vestibular, visual, auditory, motor, and high level premotor systems, many of which are compromised in PD.3 Previous research found that 46% of the PD subjects fell within a three month period, and that 21% of subjects had their first fall during the three month period.4 Postural instability is a hallmark sign of PD that compromises balance control and increases the risk of falling.5,6

Many falls in PD occur because of postural instability and their inability to organize sensory information. The SOT identifies abnormalities in postural control, somatosensory, visual, and vestibular sensory systems. It offers a composite score that is a percentage based on normal age controls. We recently presented an abstract at the World Parkinson's Conference in Montreal, Canada that showed individual's with PD (n=20) who were categorized as fallers, scored lower on the SOT than non-fallers with PD.7

The pathogenesis of PD is a progressive neurologic depletion of dopaminergic neurons from the basal ganglia which manifests as common motor or extrapyramidal signs: tremor, bradykinesia, and rigidity. As the severity of PD progresses there is frequently postural instability and further disability. There have been relatively few studies investigating the effect of OMM on PD patients. One previous research study demonstrated that a single session of osteopathic manipulative medicine protocol on 10 PD subjects improved gait compared to age-matched sham-controls, particularly stride length, cadence, and maximum velocities of upper and lower extremities.8 Other studies on non-PD subjects have shown that OMM can improve subject balance. In a pilot study 20 elderly subjects with OMM protocol applied weekly for four weeks showed an improvement in postural instability, as measured by changes in anterior-posterior and medial-lateral sway on force plate observations.9 OMM has also been shown to improve subjects with dizziness. The outcomes were measured using the SMART Balance Master©. It was found that the composite score on the SMART Balance Master© significantly improved immediately after intervention as well as one week later. (P<.001)10

OMM utilized in improving gait in PD patients addressed muscle hypertonicity and joint motion restrictions by using muscle energy and articulatory techniques for the spine and the extremities.8 OMM techniques that were used to address balance focused on removing muscle spasms and restrictions of the spine and cranium. Based on our experience of treating PD patients in our clinical practice and the improvement of symptoms in the forementioned studies we developed a PARK-OMM protocol to utilize in this study. The protocol starts with a CV4 technique, which helps to address cranial restrictions, and can potentially affect patient's autonomic function.11,12 The protocol then proceeds to address each major spinal region and the extremities by decreasing muscle hypertonicity and increasing joint range of motion with direct OMM articulatory and muscle energy techniques. These techniques were selected due to their document efficacy in improving joint mobility in the general population as well as in PD both in clinical practice and documented prior studies.13

Hypothesis: OMM treatments twice a week over a 6-week period on PD subjects using a defined OMM protocol will produce a prolonged improvement in motor function measured by the Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and balance measured by the NeurCom SMART Balance Master© Sensory Organization Test (SOT) leading to a reduced number of falls. We are also going to screen for serum biomarker changes to investigate the potential effects of OMM. We expect that the OMM cohort will have significantly improved motor function scores, balance, and an associated decrease in falls. This would help to establish the role of OMM in the treatment of PD. Positive findings may also lead to additional studies investigating how OMM impacts the quality of life in PD patients. It could also promote further investigation on the potential mechanisms of OMM amongst the PD population.

Being tested
OMM treatment arm, Counseling
Keywords
Parkinson's Disease, Osteopathic Manipulative Medicine, Falls, Balance, Motor function
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMM treatment armProcedure or surgery

    Also called Osteopathic Manipulative Treatment (OMT), Osteopathic Manipulative Medicine (OMM), PARK-OMM

    OMM is a gentle hand-on manual therapy. The research team created a protocol coined "PARK-OMM" protocol. These techniques aim to help treat myofascial restrictions and improve joint range of motion.

  • CounselingOther

    Patients will be counseled on Parkinson's Disease related issues including prevention of falls, medications, diet, nutrition, exercise, tai-chi, yoga, meditation, and mental health.

Study groups in NCT02107638
Study groupRoleWhat they receive
OMM treatment armExperimentalSubject will receive osteopathic manipulative treatment protocol for Parkinson's disease (PARK-OMM), twice a week for 6 weeks.
Receives: Procedure: OMM treatment arm
CounselingActive comparatorSubjects will receive counseling sessions weekly to match the face to face time with a physician during the OMM treatment arm. No OMM will be performed during this 6 week counseling study period.
Receives: Other: Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of falls

    A fall log will be kept for subjects enrolled to see if there is a difference between those treated the OMM protocol or those who do not

    Measured: 10 week period

Secondary outcomes (1)
  1. Balance

    Balance will be measured via SOT measurements

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study start15 Apr 2014
  3. Primary completionApr 2023
  4. Study completionApr 2023

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02107638
Sponsor's protocol ID
BHS-975
Status last verified
Aug 2024
First submitted
4 Apr 2014
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wells MR, Giantinoto S, D'Agate D, Areman RD, Fazzini EA, Dowling D, Bosak A. Standard osteopathic manipulative treatment acutely improves gait performance in patients with Parkinson's disease. J Am Osteopath Assoc. 1999 Feb;99(2):92-8. doi: 10.7556/jaoa.1999.99.2.92.

    PubMed 10079641
  • Lopez D, King HH, Knebl JA, Kosmopoulos V, Collins D, Patterson RM. Effects of comprehensive osteopathic manipulative treatment on balance in elderly patients: a pilot study. J Am Osteopath Assoc. 2011 Jun;111(6):382-8. doi: 10.7556/jaoa.2011.111.6.382.

    PubMed 21771924
  • Fraix M, Gordon A, Graham V, Hurwitz E, Seffinger MA. Use of the SMART Balance Master to quantify the effects of osteopathic manipulative treatment in patients with dizziness. J Am Osteopath Assoc. 2013 May;113(5):394-403.

    PubMed 23667193
  • DiFrancisco-Donoghue J, Apoznanski T, de Vries K, Jung MK, Mancini J, Yao S. Osteopathic manipulation as a complementary approach to Parkinson's disease: A controlled pilot study. NeuroRehabilitation. 2017;40(1):145-151. doi: 10.3233/NRE-161400.

    PubMed 27814309

Questions about this trial

What is this clinical trial studying?

A study testing OMM treatment arm and Counseling in people with Parkinson Disease, 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 2 inclusion and 3 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 7 Aug 2024. 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?

Number of falls (time frame: 10 week period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107638, which also lists 4 linked publications.

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 7 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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