Clinical trial NCT05884944: Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients
Official title: Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Osteopathy in Diseases Classified Elsewhere
Keywords: Osteopathic Manipulative Medicine
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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)

Primary outcomes:
measure: Mechanical stress via the MyotonPro
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Dynamic Stiffness via the MyotonPro
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Step Cycle time via the Biodex Gait Trainer 3
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Average step length via the Biodex Gait Trainer 3
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Step Symmetry- time on each foot via the Biodex Gait Trainer 3
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Goniometer- Hip ROM (Flexion and Extension)
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Goniometer- Hip ROM Flexion
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Goniometer- Hip ROM Extension
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Goniometer- Knee ROM - Flexion
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Goniometer- Knee ROM - Extension
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Goniometer- Ankle ROM- Dorsiflexion
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: Goniometer- Ankle ROM- Plantarflexion
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
measure: The Timed Up & Go- 3 Meter walk
timeFrame: Pre and Post intervention(1 hour)- change is being assessed
Secondary outcomes:
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Pre intervention and 1 week Post intervention - change is being assessed
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: NYIT College of Osteopathic Medicine
state: New York
Study officials:
References: