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NCT Number: NCT05884944

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Osteopathy in Diseases Classified Elsewhere Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYIT College of Osteopathic Medicine

Old Westbury, New York, 11568, United States

Location status: Recruiting

Location contact

Sheldon Yao, DO

CONTACT

[email protected]

516-686-1300

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sham- Light touch, not reaching restrictive barrier

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.

Experimental: Interventional Group- OMM- Muscle energy

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.

Primary outcomes

  1. Mechanical stress via the MyotonPro

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    Mechanical Stress Relaxation Time [ms]

  2. Dynamic Stiffness via the MyotonPro

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    Dynamic Stiffness [N/m]

  3. Step Cycle time via the Biodex Gait Trainer 3

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit. Step cycle time- Cycles/ second

  4. Average step length via the Biodex Gait Trainer 3

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit.

    Average Step length in Cm

  5. Step Symmetry- time on each foot via the Biodex Gait Trainer 3

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    Gait will be investigated utilizing the Biodex Gait Trainer 3. Measurements will be taken during a two minute walk before and after treatment or sham protocol at the visit. Measurements include step symmetry via the time on each foot in percentage(%)

  6. Goniometer- Hip ROM (Flexion and Extension)

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    A goniometer will be used to assess range of motion of the hip in degrees

  7. Goniometer- Hip ROM Flexion

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    A goniometer will be used to assess range of motion of the hip in degrees

  8. Goniometer- Hip ROM Extension

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    A goniometer will be used to assess range of motion of the hip in degrees

  9. Goniometer- Knee ROM - Flexion

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    A goniometer will be used to assess range of motion of the Knee in degrees

  10. Goniometer- Knee ROM - Extension

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    A goniometer will be used to assess range of motion of the knee in degrees

  11. Goniometer- Ankle ROM- Dorsiflexion

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    A goniometer will be used to assess range of motion of the ankle in degrees

  12. Goniometer- Ankle ROM- Plantarflexion

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    A goniometer will be used to assess range of motion of the ankle in degrees

  13. The Timed Up & Go- 3 Meter walk

    Time frame: Pre and Post intervention(1 hour)- change is being assessed

    The Timed Up & Go (TUG) test measures one's ability to rise up from a seated chair position, walk 3 meters, turn, walk back, and sit down in the chair- measure in seconds

Secondary outcomes

  1. Lower Extremity Functional Scale (LEFS)

    Time frame: Pre intervention and 1 week Post intervention - change is being assessed

    Lower Extremity Functional Scale (LEFS) will be used to assess difficulty with daily activities as a result of lower extremity dysfunction. Minimum value is 9 Maximum value is 80. The higher the score, the lower the disability.

Study contacts

Contact information is provided by the study sponsor or research team.

Sheldon Yao, DO

CONTACT

[email protected]

516-686-1300

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2023
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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