Effect of Osteopathic Manipulative Medicine on Parkinson Disease
1 other identifier
interventional
33
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Apr 2014
Longer than P75 for not_applicable parkinson-disease
1 active site
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
First Submitted
Initial submission to the registry
April 4, 2014
CompletedFirst Posted
Study publicly available on registry
April 8, 2014
CompletedStudy Start
First participant enrolled
April 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedAugust 7, 2024
August 1, 2024
9 years
April 4, 2014
August 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
10 week period
Secondary Outcomes (1)
Balance
10 weeks
Other Outcomes (2)
Motor function
10-weeks
Serum biomarkers
6 weeks
Study Arms (2)
OMM treatment arm
EXPERIMENTALSubject will receive osteopathic manipulative treatment protocol for Parkinson's disease (PARK-OMM), twice a week for 6 weeks.
Counseling
ACTIVE 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Medically diagnosed with Parkinson's Disease
- Over the age of 40
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York Institute of Technologylead
- American Osteopathic Associationcollaborator
Study Sites (1)
New York Institute of Technology - Academic Health Care Center
Old Westbury, New York, 11568, United States
Related Publications (4)
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.
PMID: 10079641BACKGROUNDLopez 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.
PMID: 21771924BACKGROUNDFraix 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.
PMID: 23667193BACKGROUNDDiFrancisco-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.
PMID: 27814309BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheldon Yao, DO
NYIT College of Osteopathic Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Chair of the Department of OMM
Study Record Dates
First Submitted
April 4, 2014
First Posted
April 8, 2014
Study Start
April 15, 2014
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
August 7, 2024
Record last verified: 2024-08