| Field | Value |
|---|---|
| NCT Number | NCT05884944 |
| Status | RECRUITING |
| Phase | Not Applicable |
| Sponsor | New York Institute of Technology |
| Study Type | Interventional |
| Allocation | Randomized |
| Intervention | Osteopathic Manipulative Medicine (OMM) - Muscle Energy Technique |
| Conditions | Parkinson's Disease, Osteopathy in Diseases Classified Elsewhere |
| Enrollment | 20 participants (estimated) |
| Start Date | July 6, 2023 |
| Primary Completion | December 2025 (estimated) |
Sheldon Yao, DO — Chair, Professor, Department of Osteopathic Manipulative Medicine, New York Institute of Technology
Contact: syao@nyit.edu | (516) 686-1300
NYIT College of Osteopathic Medicine, Old Westbury, New York, United States
Parkinsonism, most commonly caused by Parkinson's disease (PD), is characterized by rest tremor, rigidity, bradykinesia, and postural instability. Gait speed and endurance directly inhibit independence and community engagement for those with PD. Pain ranks among the most troublesome non-motor symptoms associated with PD, and rigidity is commonly associated with pain in patients with PD.
Osteopathic medicine treats somatic dysfunction — impaired function of body components including the somatic, skeletal, myofascial, vascular, lymphatic, and neural systems. Osteopathic manipulative treatment (OMT) aims to restore proper function by addressing these interconnected systems.
Theoretical Mechanisms:
Lower extremity dysfunction significantly impacts:
The trial focuses on hip, knee, and ankle joints bilaterally, targeting muscles that are critical for mobility and posture.
For the OMM treatment group, an osteopathic manipulative treatment protocol is 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:
Muscle energy technique is a direct active treatment where the subject moves their joint in a direction against a counterforce by the treatment provider for 3 seconds, repeated 3 times, followed by a passive stretch applied by the provider.
The sham group receives passive range of motion (PROM) joint movement of the hip, knee, and ankles bilaterally without reaching the joint physiologic barrier. This mimics the OMM treatment duration and physical contact without providing the therapeutic intervention.
Based on Wells et al. (1999) sham procedure protocol.
| Measure | Instrument | Description |
|---|---|---|
| Mechanical Stress Relaxation Time | MyotonPro | [ms] |
| Dynamic Stiffness | MyotonPro | [N/m] |
| Step Cycle Time | Biodex Gait Trainer 3 | Cycles/second during 2-minute walk |
| Average Step Length | Biodex Gait Trainer 3 | [cm] during 2-minute walk |
| Step Symmetry | Biodex Gait Trainer 3 | Time on each foot [%] |
| Hip ROM (Flexion/Extension) | Goniometer | Degrees |
| Knee ROM (Flexion/Extension) | Goniometer | Degrees |
| Ankle ROM (Dorsiflexion/Plantarflexion) | Goniometer | Degrees |
| Timed Up & Go (TUG) | 3-meter walk | Seconds |
| Measure | Instrument | Description |
|---|---|---|
| Lower Extremity Functional Scale (LEFS) | Questionnaire | Scale 9-80; higher = less disability |
If successful, this trial could demonstrate:
Positive results would support:
This trial uses objective instrumentation (MyotonPro, Biodex Gait Trainer) to quantify changes, which is more rigorous than many physical therapy studies relying solely on clinical scales.