Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients
- Conditions
- Parkinson DiseaseOsteopathy in Diseases Classified Elsewhere
- Interventions
- Procedure: Sham- Light touch, not reaching restrictive barrier
- Registration Number
- NCT05884944
- Lead Sponsor
- New York Institute of Technology
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group- Sham- Light touch, not reaching restrictive barrier 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.
- Primary Outcome Measures
Name Time Method Mechanical stress via the MyotonPro Pre and Post intervention(1 hour)- change is being assessed Mechanical Stress Relaxation Time \[ms\]
Step Cycle time via the Biodex Gait Trainer 3 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
Average step length via the Biodex Gait Trainer 3 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 CmStep Symmetry- time on each foot via the Biodex Gait Trainer 3 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(%)
Goniometer- Knee ROM - Extension 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
Dynamic Stiffness via the MyotonPro Pre and Post intervention(1 hour)- change is being assessed Dynamic Stiffness \[N/m\]
Goniometer- Hip ROM Flexion 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
Goniometer- Hip ROM Extension 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
Goniometer- Hip ROM (Flexion and Extension) 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
The Timed Up & Go- 3 Meter walk 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
Goniometer- Knee ROM - Flexion 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
Goniometer- Ankle ROM- Dorsiflexion 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
Goniometer- Ankle ROM- Plantarflexion 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
- Secondary Outcome Measures
Name Time Method Lower Extremity Functional Scale (LEFS) 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.
Trial Locations
- Locations (1)
NYIT College of Osteopathic Medicine
🇺🇸Old Westbury, New York, United States