Parkinson DiseaseNCT05884944
Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients
A study testing Experimental: Interventional Group- OMM- Muscle energy in people with Parkinson Disease and Osteopathy in Diseases Classified Elsewhere, run by New York Institute of Technology at 1 site in United States.
Trial summary
The purpose of the study is to investigate the effects that Osteopathic Manipulative Medicine has on lower extremity muscle characteristics in PD. Muscle stiffness, range of motion, and gait will be measured. Participants will be asked to attend one in person session at the NYIT Academic Health Care Center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Osteopathy in Diseases Classified Elsewhere
- What is being tested?
- Experimental: Interventional Group- OMM- Muscle energy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2023to Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's disease as per a neurologist, a severity of 2-4 on the Hoehn and Yahr (H-Y) Scale
- Able to receive OMM
- Able to be in a supine and prone position for MyotonPRO measurements
- Able to ambulate for gait measurements
- Have musculoskeletal complaints of leg pain/cramping or gait abnormalities due to their PD
Who cannot join
- Presence of severe fasciculations based on clinical judgment due to interference with measurements
- Gait disorders not attributed to PD
- Presence of other medical neurologic diagnoses that can affect outcome measures such as muscle tone/stiffness and ambulation (ie stroke, multiple sclerosis)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NYIT College of Osteopathic Medicine
Old Westbury, New York, 11568
Sheldon Yao, DO, 516-686-1300, sheldon.yao@nyit.edu
About this study
The purpose of the study is to investigate the effects that Osteopathic Manipulative Medicine has on lower extremity muscle characteristics in PD. Muscle stiffness, range of motion, and gait will be measured.
Participants will be asked to attend one in person session at the NYIT Academic Health Care Center. Participants will be randomly assigned to a control or experimental group. After a visit with the treating physician, both groups will have muscle stiffness tested using a myotonometry meter via a MyotonPRO device, gait measured while walking on a treadmill for 2 minutes before and after treatment, and range of motion tested using a goniometer. One week after the visit, participants will be asked to complete a brief survey over the phone with one of the study investigators.
Read the detailed description
Parkinsonism, most commonly caused by Parkinson's disease (PD), is a syndrome characterized by rest tremor, rigidity, bradykinesia, and postural instability. Gait speed and endurance directly inhibit the independence and community engagement for those with Parkinson's disease (PD). Pain was ranked as one of the most troublesome nonmotor symptoms associated with PD. Rigidity is commonly associated with pain in patients with PD. Osteopathic medicine treats somatic dysfunction which is the impaired function of body components including the somatic, skeletal, myofascial, vascular, lymphatic, and neural systems. Osteopathic manipulative treatment (OMT) will be applied to the lower extremity (LE), specifically muscle energy technique (MET) to the hip, knee, and ankle bilaterally. A sham control group will receive passive range of motion (PROM) joint movement of the hip, knee, and ankles bilaterally without reaching joint physiologic barrier. Muscle and gait parameters, ROM, Timed Up \& Go (TUG) and LE functionality will be assessed and juxtaposed. Based on preliminary results of muscle measurements, stiffness and relaxation improved in a patient with PD before and after LE OMT and demonstrated to be feasible. Investigators intend for the patients who receive OMT to improve LE muscle quality, gait, ROM, TUG, and daily functionality. Through this research Investigators hope to demonstrate that OMM as a supplemental treatment regimen can improve quality of life in those living with PD.
- Being tested
- Sham- Light touch, not reaching restrictive barrier, Experimental: Interventional Group- OMM- Muscle energy
- Keywords
- Osteopathic Manipulative Medicine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham- Light touch, not reaching restrictive barrierProcedure or surgery
Sham- Light touch, not reaching restrictive barrier For the control group, the subjects hip, knee, and ankle joints will be moved bilaterally 3 times into each plane to mimic the OMM muscle energy treatment. The joint will be moved in each plane of motion without reaching the joint barrier. The hip joint will be moved into adduction, extension, and flexion, the knee joint will be moved into extension and flexion, and the ankle will be moved into plantarflexion and dorsiflexion 3 times in each direction without reaching the barrier passively.
Experimental: Interventional Group- OMM- Muscle energyProcedure or surgery
The interventional group will received Osteopathic Manipulative Medicine, specifically Muscle energy treatment. An osteopathic manipulative treatment protocol will be applied to the lower extremity joints bilaterally. Muscle energy technique (MET) will be applied to the hip, knee, and ankle bilaterally based on the protocol from Atlas of Osteopathic Techniques. The adductor, extensor, and flexor muscles of the hip joint will be treated, the extensors and flexors of the knee joint will be treated, and the plantar and dorsiflexion muscles of the ankle will be treated. Muscle energy is a direct active treatment asking the subject to move their joint in a direction against a counterforce by the treatment provider for 3 times for 3 seconds and repeating the procedure 3 times and afterwards a passive stretch to the joint is applied by the provider.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group- OMM- Muscle energy | Experimental | For the OMM treatment group, an osteopathic manipulative treatment protocol will be applied to the lower extremities, specifically muscle energy technique (MET) to the hip, knee, and ankle bilaterally based on the protocol from Atlas of Osteopathic Techniques. The adductor, extensor, and flexor muscles of the hip joint will be treated, the extensors and flexors of the knee joint will be treated, and the plantar and dorsiflexion muscles of the ankle will be treated Receives: Procedure: Experimental: Interventional Group- OMM- Muscle energy |
| Control Group- Sham- Light touch, not reaching restrictive barrier | Sham comparator | Joint articulation without engaging joint barriers The sham group will serve as the control group and will receive a sham-control procedure as outlined in the paper by Wells, et al in which they will undergo voluntary ROM and then passive movement with the same joint movements without reaching their barrier and no isometric contraction (Wells et al. 1999) The proposed sham procedure will occupy the same amount of time as MET treatment. Receives: Procedure: Sham- Light touch, not reaching restrictive barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical stress via the MyotonPro
Mechanical Stress Relaxation Time [ms]
Measured: Pre and Post intervention(1 hour)- change is being assessed
Dynamic Stiffness via the MyotonPro
Dynamic Stiffness [N/m]
Measured: Pre and Post intervention(1 hour)- change is being assessed
Step Cycle time via the Biodex Gait Trainer 3
Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit. Step cycle time- Cycles/ second
Measured: Pre and Post intervention(1 hour)- change is being assessed
Average step length via the Biodex Gait Trainer 3
Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit.
Average Step length in Cm
Measured: Pre and Post intervention(1 hour)- change is being assessed
Step Symmetry- time on each foot via the Biodex Gait Trainer 3
Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit. Measurements include step symmetry via the time on each foot in percentage(%)
Measured: Pre and Post intervention(1 hour)- change is being assessed
Goniometer- Hip ROM (Flexion and Extension)
A goniometer will be used to assess range of motion of the hip in degrees
Measured: Pre and Post intervention(1 hour)- change is being assessed
Goniometer- Hip ROM Flexion
A goniometer will be used to assess range of motion of the hip in degrees
Measured: Pre and Post intervention(1 hour)- change is being assessed
Goniometer- Hip ROM Extension
A goniometer will be used to assess range of motion of the hip in degrees
Measured: Pre and Post intervention(1 hour)- change is being assessed
Goniometer- Knee ROM - Flexion
A goniometer will be used to assess range of motion of the Knee in degrees
Measured: Pre and Post intervention(1 hour)- change is being assessed
Goniometer- Knee ROM - Extension
A goniometer will be used to assess range of motion of the knee in degrees
Measured: Pre and Post intervention(1 hour)- change is being assessed
Goniometer- Ankle ROM- Dorsiflexion
A goniometer will be used to assess range of motion of the ankle in degrees
Measured: Pre and Post intervention(1 hour)- change is being assessed
Goniometer- Ankle ROM- Plantarflexion
A goniometer will be used to assess range of motion of the ankle in degrees
Measured: Pre and Post intervention(1 hour)- change is being assessed
The Timed Up & Go- 3 Meter walk
The Timed Up \& Go (TUG) test measures one's ability to rise up from a seated chair position, walk 3 meters, turn, walk back, and sit down in the chair- measure in seconds
Measured: Pre and Post intervention(1 hour)- change is being assessed
Secondary outcomes (1)
Lower Extremity Functional Scale (LEFS)
Lower Extremity Functional Scale (LEFS) will be used to assess difficulty with daily activities as a result of lower extremity dysfunction. Minimum value is 9 Maximum value is 80. The higher the score, the lower the disability.
Measured: Pre intervention and 1 week Post intervention - change is being assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start6 Jul 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheldon Yao, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884944
- Sponsor's protocol ID
- BHS-1850
- Status last verified
- Aug 2024
- First submitted
- 30 Mar 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients
- ClinicalTrials.gov ID
- NCT05884944
- Acronym / sponsor ID
- BHS-1850
- Keywords
- Osteopathic Manipulative Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Jun 2023 (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.
The purpose of the study is to investigate the effects that Osteopathic Manipulative Medicine has on lower extremity muscle characteristics in PD. Muscle stiffness, range of motion, and gait will be measured.
Participants will be asked to attend one in person session at the NYIT Academic Health Care Center. Participants will be randomly assigned to a control or experimental group. After a visit with the treating physician, both groups will have muscle stiffness tested using a myotonometry meter via a MyotonPRO device, gait measured while walking on a treadmill for 2 minutes before and after treatment, and range of motion tested using a goniometer. One week after the visit, participants will be asked to complete a brief survey over the phone with one of the study investigators.
Detailed description
Parkinsonism, most commonly caused by Parkinson's disease (PD), is a syndrome characterized by rest tremor, rigidity, bradykinesia, and postural instability. Gait speed and endurance directly inhibit the independence and community engagement for those with Parkinson's disease (PD). Pain was ranked as one of the most troublesome nonmotor symptoms associated with PD. Rigidity is commonly associated with pain in patients with PD. Osteopathic medicine treats somatic dysfunction which is the impaired function of body components including the somatic, skeletal, myofascial, vascular, lymphatic, and neural systems. Osteopathic manipulative treatment (OMT) will be applied to the lower extremity (LE), specifically muscle energy technique (MET) to the hip, knee, and ankle bilaterally. A sham control group will receive passive range of motion (PROM) joint movement of the hip, knee, and ankles bilaterally without reaching joint physiologic barrier. Muscle and gait parameters, ROM, Timed Up \& Go (TUG) and LE functionality will be assessed and juxtaposed. Based on preliminary results of muscle measurements, stiffness and relaxation improved in a patient with PD before and after LE OMT and demonstrated to be feasible. Investigators intend for the patients who receive OMT to improve LE muscle quality, gait, ROM, TUG, and daily functionality. Through this research Investigators hope to demonstrate that OMM as a supplemental treatment regimen can improve quality of life in those living with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group- OMM- Muscle energy | Experimental | Procedure: Experimental: Interventional Group- OMM- Muscle energyFor the OMM treatment group, an osteopathic manipulative treatment protocol will be applied to the lower extremities, specifically muscle energy technique (MET) to the hip, knee, and ankle bilaterally based on the protocol from Atlas of Osteopathic Techniques. The adductor, extensor, and flexor muscles of the hip joint will be treated, the extensors and flexors of the knee joint will be treated, and the plantar and dorsiflexion muscles of the ankle will be treated |
| Control Group- Sham- Light touch, not reaching restrictive barrier | Sham comparator | Procedure: Sham- Light touch, not reaching restrictive barrierJoint articulation without engaging joint barriers The sham group will serve as the control group and will receive a sham-control procedure as outlined in the paper by Wells, et al in which they will undergo voluntary ROM and then passive movement with the same joint movements without reaching their barrier and no isometric contraction (Wells et al. 1999) The proposed sham procedure will occupy the same amount of time as MET treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Parkinson's disease as per a neurologist, a severity of 2-4 on the Hoehn and Yahr (H-Y) Scale
- Able to receive OMM
- Able to be in a supine and prone position for MyotonPRO measurements
- Able to ambulate for gait measurements
- Have musculoskeletal complaints of leg pain/cramping or gait abnormalities due to their PD
Key exclusion criteria (3 listed)
- Presence of severe fasciculations based on clinical judgment due to interference with measurements
- Gait disorders not attributed to PD
- Presence of other medical neurologic diagnoses that can affect outcome measures such as muscle tone/stiffness and ambulation (ie stroke, multiple sclerosis)
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 |
|---|---|---|
| Sham- Light touch, not reaching restrictive barrierSham- Light touch, not reaching restrictive barrier For the control group, the subjects hip, knee, and ankle joints will be moved bilaterally 3 times into each plane to mimic the OMM muscle energy treatment. The joint will be moved in each plane of motion without reaching the joint barrier. The hip joint will be moved into adduction, extension, and flexion, the knee joint will be moved into extension and flexion, and the ankle will be moved into plantarflexion and dorsiflexion 3 times in each direction without reaching the barrier passively. | Procedure or surgery | Control Group- Sham- Light touch, not reaching restrictive barrier |
| Experimental: Interventional Group- OMM- Muscle energyThe interventional group will received Osteopathic Manipulative Medicine, specifically Muscle energy treatment. An osteopathic manipulative treatment protocol will be applied to the lower extremity joints bilaterally. Muscle energy technique (MET) will be applied to the hip, knee, and ankle bilaterally based on the protocol from Atlas of Osteopathic Techniques. The adductor, extensor, and flexor muscles of the hip joint will be treated, the extensors and flexors of the knee joint will be treated, and the plantar and dorsiflexion muscles of the ankle will be treated. Muscle energy is a direct active treatment asking the subject to move their joint in a direction against a counterforce by the treatment provider for 3 times for 3 seconds and repeating the procedure 3 times and afterwards a passive stretch to the joint is applied by the provider. | Procedure or surgery | Interventional Group- OMM- Muscle energy |
Primary outcome
Mechanical stress via the MyotonPro
Time frame: Pre and Post intervention(1 hour)- change is being assessed
Mechanical Stress Relaxation Time [ms]
Dynamic Stiffness via the MyotonPro
Time frame: Pre and Post intervention(1 hour)- change is being assessed
Dynamic Stiffness [N/m]
Step Cycle time via the Biodex Gait Trainer 3
Time frame: Pre and Post intervention(1 hour)- change is being assessed
Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit. Step cycle time- Cycles/ second
Average step length via the Biodex Gait Trainer 3
Time frame: Pre and Post intervention(1 hour)- change is being assessed
Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit. Average Step length in Cm
Step Symmetry- time on each foot via the Biodex Gait Trainer 3
Time frame: Pre and Post intervention(1 hour)- change is being assessed
Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit. Measurements include step symmetry via the time on each foot in percentage(%)
Goniometer- Hip ROM (Flexion and Extension)
Time frame: Pre and Post intervention(1 hour)- change is being assessed
A goniometer will be used to assess range of motion of the hip in degrees
Goniometer- Hip ROM Flexion
Time frame: Pre and Post intervention(1 hour)- change is being assessed
A goniometer will be used to assess range of motion of the hip in degrees
Goniometer- Hip ROM Extension
Time frame: Pre and Post intervention(1 hour)- change is being assessed
A goniometer will be used to assess range of motion of the hip in degrees
Goniometer- Knee ROM - Flexion
Time frame: Pre and Post intervention(1 hour)- change is being assessed
A goniometer will be used to assess range of motion of the Knee in degrees
Goniometer- Knee ROM - Extension
Time frame: Pre and Post intervention(1 hour)- change is being assessed
A goniometer will be used to assess range of motion of the knee in degrees
Goniometer- Ankle ROM- Dorsiflexion
Time frame: Pre and Post intervention(1 hour)- change is being assessed
A goniometer will be used to assess range of motion of the ankle in degrees
Goniometer- Ankle ROM- Plantarflexion
Time frame: Pre and Post intervention(1 hour)- change is being assessed
A goniometer will be used to assess range of motion of the ankle in degrees
The Timed Up & Go- 3 Meter walk
Time frame: Pre and Post intervention(1 hour)- change is being assessed
The Timed Up \& Go (TUG) test measures one's ability to rise up from a seated chair position, walk 3 meters, turn, walk back, and sit down in the chair- measure in seconds
1 secondary outcome
Lower Extremity Functional Scale (LEFS)
Time frame: Pre intervention and 1 week Post intervention - change is being assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Interventional Group- OMM- Muscle energy in people with Parkinson Disease and Osteopathy in Diseases Classified Elsewhere, 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 5 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: status not confirmed, 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheldon Yao, DO (516-686-1300, syao@nyit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical stress via the MyotonPro (time frame: Pre and Post intervention(1 hour)- change is being assessed). The study lists 13 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 7 Aug 2024.