RecruitingNot Applicable

Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients

United States20 participantsStarted 2023-07-06

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mechanical stress via the MyotonPro

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Dynamic Stiffness via the MyotonPro

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Step Cycle time via the Biodex Gait Trainer 3

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Average step length via the Biodex Gait Trainer 3

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Step Symmetry- time on each foot via the Biodex Gait Trainer 3

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Goniometer- Hip ROM (Flexion and Extension)

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Goniometer- Hip ROM Flexion

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Trial details

NCT IDNCT05884944

SponsorNew York Institute of Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Sheldon Yao, DO

516-686-1300 syao@nyit.edu

View on ClinicalTrials.gov More Parkinson Disease trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mechanical stress via the MyotonPro

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Dynamic Stiffness via the MyotonPro

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Step Cycle time via the Biodex Gait Trainer 3

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Average step length via the Biodex Gait Trainer 3

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Step Symmetry- time on each foot via the Biodex Gait Trainer 3

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Goniometer- Hip ROM (Flexion and Extension)

Timeframe: Pre and Post intervention(1 hour)- change is being assessed

Goniometer- Hip ROM Flexion

Timeframe: Pre and Post intervention(1 hour)- change is being assessed