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

Overview

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.

Detailed description

Parkinsonism, most commonly caused by Parkinson's disease (PD), is a syndrome characterized by rest tremor, rigidity, bradykinesia, and postural instability. Gait speed and endurance directly inhibit the independence and community engagement for those with Parkinson's disease (PD). Pain was ranked as one of the most troublesome nonmotor symptoms associated with PD. Rigidity is commonly associated with pain in patients with PD. Osteopathic medicine treats somatic dysfunction which is the impaired function of body components including the somatic, skeletal, myofascial, vascular, lymphatic, and neural systems. Osteopathic manipulative treatment (OMT) will be applied to the lower extremity (LE), specifically muscle energy technique (MET) to the hip, knee, and ankle bilaterally. A sham control group will receive passive range of motion (PROM) joint movement of the hip, knee, and ankles bilaterally without reaching joint physiologic barrier. Muscle and gait parameters, ROM, Timed Up \& Go (TUG) and LE functionality will be assessed and juxtaposed. Based on preliminary results of muscle measurements, stiffness and relaxation improved in a patient with PD before and after LE OMT and demonstrated to be feasible. Investigators intend for the patients who receive OMT to improve LE muscle quality, gait, ROM, TUG, and daily functionality. Through this research Investigators hope to demonstrate that OMM as a supplemental treatment regimen can improve quality of life in those living with PD.

Interventions

• Procedure Sham- Light touch, not reaching restrictive barrier
  Sham- 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 di
• Procedure Experimental: Interventional Group- OMM- Muscle energy
  The 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

Primary outcome measures

• Mechanical stress via the MyotonPro [Time frame: Pre and Post intervention(1 hour)- change is being assessed]
• Dynamic Stiffness via the MyotonPro [Time frame: Pre and Post intervention(1 hour)- change is being assessed]
• Step Cycle time via the Biodex Gait Trainer 3 [Time frame: Pre and Post intervention(1 hour)- change is being assessed]
• Average step length via the Biodex Gait Trainer 3 [Time frame: Pre and Post intervention(1 hour)- change is being assessed]
• Step Symmetry- time on each foot via the Biodex Gait Trainer 3 [Time frame: Pre and Post intervention(1 hour)- change is being assessed]
• Goniometer- Hip ROM (Flexion and Extension) [Time frame: Pre and Post intervention(1 hour)- change is being assessed]
• Goniometer- Hip ROM Flexion [Time frame: Pre and Post intervention(1 hour)- change is being assessed]
• Goniometer- Hip ROM Extension [Time frame: Pre and Post intervention(1 hour)- change is being assessed]
• Goniometer- Knee ROM - Flexion [Time frame: Pre and Post intervention(1 hour)- change is being assessed]
• Goniometer- Knee ROM - Extension [Time frame: Pre and Post intervention(1 hour)- change is being assessed]

Secondary outcome measures (1)

• Lower Extremity Functional Scale (LEFS) [Time frame: Pre intervention and 1 week Post intervention - change is being assessed]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• NYIT College of Osteopathic Medicine — Old Westbury

Identifiers

NCT: NCT05884944 · BHS-1850

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗