Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients
Part of paid clinical trials in Old Westbury, New York.
- Sponsor
- New York Institute of Technology
- Study ID
- NCT05884944
- Status
- Recruiting
Conditions
- Osteopathy in Diseases Classified Elsewhere
- Parkinson Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Sham- Light touch, not reaching restrictive barrier — PROCEDURESham- 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 energy — PROCEDUREThe 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 Details
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.
Key Dates
- Start date
- Jul 6, 2023
- Status verified
- Aug 2024
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- 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
- Sham Comparator: Control Group- 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.
Primary Outcome Measure
Mechanical stress via the MyotonPro [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
Central Contacts
- Sheldon Yao, DO516-686-1300
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYIT College of Osteopathic Medicine | Old Westbury | New York | 11568 |
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