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

New York Institute of Technology1 site in 1 country20 target enrollmentJuly 6, 2023

ConditionsParkinson Disease Osteopathy in Diseases Classified Elsewhere

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: New York Institute of Technology
Enrollment: 20
Locations: 1
Primary Endpoint: Mechanical stress via the MyotonPro
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 6, 2023

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

New York Institute of Technology

Responsible Party

Principal Investigator

Sheldon Yao

Chair, Professor OMM Department

New York Institute of Technology

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)