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

NCT ID: NCT05884944

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2025-12-31

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.

Conditions

Parkinson Disease; Osteopathy in Diseases Classified Elsewhere

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interventional Group- OMM- Muscle energy

For 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

Group Type: EXPERIMENTAL

Experimental: Interventional Group- OMM- Muscle energy

Intervention Type: PROCEDURE

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, 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.

Control Group- Sham- Light touch, not reaching restrictive barrier

Joint 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.

Group Type: SHAM_COMPARATOR

Sham- Light touch, not reaching restrictive barrier

Intervention Type: PROCEDURE

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 direction without reaching the barrier passively.

Interventions

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 direction without reaching the barrier passively.

Intervention Type: 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, 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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Sheldon Yao

Chair, Professor OMM Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NYIT College of Osteopathic Medicine

Old Westbury, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sheldon Yao, DO

Role: CONTACT

syao@nyit.edu

516-686-1300

Facility Contacts

Sheldon Yao, DO

Role: primary

sheldon.yao@nyit.edu

516-686-1300

Other Identifiers

BHS-1850

Identifier Type: -

Identifier Source: org_study_id