Reduce lower extremity muscle stiffness
- Trial ID
- NCT05884944
- Official Title
- Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients
- Goal
- Reduce lower extremity muscle stiffness
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- New York Institute of Technology
- Study Type
- INTERVENTIONAL
- Enrollment
- 20 participants
- Conditions
- Parkinson Disease, Osteopathy in Diseases Classified Elsewhere
- Interventions
- Sham- Light touch, not reaching restrictive barrier, Experimental: Interventional Group- OMM- Muscle energy
Summary For Families
Aiming to see if osteopathic manipulative medicine, specifically muscle energy techniques, can reduce lower‑extremity muscle stiffness and improve leg pain, cramping, or gait problems in people with Parkinson's. The treatment asks patients to make gentle, active muscle contractions against the practitioner's resistance to relax and lengthen tight muscles, and outcomes are measured with a MyotonPRO device and gait tests; it is compared to a sham light touch that avoids the restrictive barrier, and as a hands‑on therapy it does not directly change medications like levodopa. Seeking adults 18 and older with a neurologist diagnosis of Parkinson's at Hoehn and Yahr stage 2 to 4 who can lie supine and prone for measurements, walk for gait testing, and have PD‑related leg symptoms. People with other neurologic conditions affecting tone or walking, non‑PD gait disorders, or severe muscle fasciculations are excluded.
Locations
- NYIT College of Osteopathic Medicine, Old Westbury, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Sham- Light touch, not reaching restrictive barrier. Aiming to see if osteopathic manipulative medicine, specifically muscle energy techniques, can reduce lower‑extremity muscle stiffness and improve leg pain, cramping, or gait problems in people with Parkinson's. The treatment asks patients to make gentle, active muscle contractions against the practitioner's resistance to relax and lengthen tight muscles, and outcomes are measured with a MyotonPRO device and gait tests; it is compared to a sham light touch that avoids the restrictive barrier, and as a hands‑on therapy it does not directly change medications like levodopa. Seeking adults 18 and older with a neurologist diagnosis of Parkinson's at Hoehn and Yahr stage 2 to 4 who can lie supine and prone for measurements, walk for gait testing, and have PD‑related leg symptoms. People with other neurologic conditions affecting tone or walking, non‑PD gait disorders, or severe muscle fasciculations are excluded.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 5 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.