Sham- Light touch, not reaching re… for Parkinson's (NCT05884944)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 5 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- One in-person session at the NYIT Academic Health Care Center.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.