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

Primary Purpose

Parkinson Disease, Osteopathy in Diseases Classified Elsewhere

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham- Light touch, not reaching restrictive barrier
Experimental: Interventional Group- OMM- Muscle energy
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Osteopathic Manipulative Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NYIT College of Osteopathic MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Interventional Group- OMM- Muscle energy

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

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Mechanical stress via the MyotonPro
Mechanical Stress Relaxation Time [ms]
Dynamic Stiffness via the MyotonPro
Dynamic Stiffness [N/m]
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
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
Step Symmetry- time on each foot 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. Measurements include step symmetry via the time on each foot in percentage(%)
Goniometer- Hip ROM (Flexion and Extension)
A goniometer will be used to assess range of motion of the hip in degrees
Goniometer- Hip ROM Flexion
A goniometer will be used to assess range of motion of the hip in degrees
Goniometer- Hip ROM Extension
A goniometer will be used to assess range of motion of the hip in degrees
Goniometer- Knee ROM - Flexion
A goniometer will be used to assess range of motion of the Knee in degrees
Goniometer- Knee ROM - Extension
A goniometer will be used to assess range of motion of the knee in degrees
Goniometer- Ankle ROM- Dorsiflexion
A goniometer will be used to assess range of motion of the ankle in degrees
Goniometer- Ankle ROM- Plantarflexion
A goniometer will be used to assess range of motion of the ankle in degrees
The Timed Up & Go- 3 Meter walk
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 Outcome Measures

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.

Full Information

First Posted
March 30, 2023
Last Updated
May 23, 2023
Sponsor
New York Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05884944
Brief Title
Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients
Official Title
Effects Of Osteopathic Manipulative Medicine(OMM) On Lower Extremity Muscle Characteristics In Parkinson's Disease(PD) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Osteopathy in Diseases Classified Elsewhere
Keywords
Osteopathic Manipulative Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Group- OMM- Muscle energy
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group- Sham- Light touch, not reaching restrictive barrier
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham- Light touch, not reaching restrictive barrier
Intervention Description
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
Intervention Name(s)
Experimental: Interventional Group- OMM- Muscle energy
Intervention Description
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 Outcome Measure Information:
Title
Mechanical stress via the MyotonPro
Description
Mechanical Stress Relaxation Time [ms]
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Title
Dynamic Stiffness via the MyotonPro
Description
Dynamic Stiffness [N/m]
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Title
Step Cycle time via the Biodex Gait Trainer 3
Description
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
Title
Average step length via the Biodex Gait Trainer 3
Description
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
Title
Step Symmetry- time on each foot via the Biodex Gait Trainer 3
Description
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(%)
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Title
Goniometer- Hip ROM (Flexion and Extension)
Description
A goniometer will be used to assess range of motion of the hip in degrees
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Title
Goniometer- Hip ROM Flexion
Description
A goniometer will be used to assess range of motion of the hip in degrees
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Title
Goniometer- Hip ROM Extension
Description
A goniometer will be used to assess range of motion of the hip in degrees
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Title
Goniometer- Knee ROM - Flexion
Description
A goniometer will be used to assess range of motion of the Knee in degrees
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Title
Goniometer- Knee ROM - Extension
Description
A goniometer will be used to assess range of motion of the knee in degrees
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Title
Goniometer- Ankle ROM- Dorsiflexion
Description
A goniometer will be used to assess range of motion of the ankle in degrees
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Title
Goniometer- Ankle ROM- Plantarflexion
Description
A goniometer will be used to assess range of motion of the ankle in degrees
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Title
The Timed Up & Go- 3 Meter walk
Description
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
Time Frame
Pre and Post intervention(1 hour)- change is being assessed
Secondary Outcome Measure Information:
Title
Lower Extremity Functional Scale (LEFS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheldon Yao, DO
Phone
516-686-1300
Email
syao@nyit.edu
Facility Information:
Facility Name
NYIT College of Osteopathic Medicine
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheldon Yao, DO
Phone
516-686-1300
Email
sheldon.yao@nyit.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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