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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNew York Institute of Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sham- Light touch, not reaching restrictive barrier

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Interventional Group- OMM- Muscle energyExperimental treatment 1 intervention
Group B: Control Group- Sham- Light touch, not reaching restrictive barrierSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mechanical stress via the MyotonPro

Mechanical Stress Relaxation Time \[ms\]

Time frame
Pre and Post intervention(1 hour)- change is being assessed
2

Dynamic Stiffness via the MyotonPro

Dynamic Stiffness \[N/m\]

Time frame
Pre and Post intervention(1 hour)- change is being assessed
3

Step Cycle time via the Biodex Gait Trainer 3

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

Time frame
Pre and Post intervention(1 hour)- change is being assessed
4

Average step length via the Biodex Gait Trainer 3

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

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

Secondary outcomes

1

Lower Extremity Functional Scale (LEFS)

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.

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

Other outcomes

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