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

NCT05884944 | Recruiting

• 1 other identifier: BHS-1850
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Osteopathy in Diseases Classified Elsewhere

Keywords

Osteopathic Manipulative Medicine

Outcome Measures

Primary Outcomes (13)

• Mechanical stress via the MyotonPro

  Mechanical Stress Relaxation Time \[ms\]

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

• Dynamic Stiffness via the MyotonPro

  Dynamic Stiffness \[N/m\]

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

• 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

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

• 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

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

• 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(%)

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

• Goniometer- Hip ROM (Flexion and Extension)

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

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

• Goniometer- Hip ROM Flexion

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

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

• Goniometer- Hip ROM Extension

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

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

• Goniometer- Knee ROM - Flexion

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

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

• Goniometer- Knee ROM - Extension

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

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

• Goniometer- Ankle ROM- Dorsiflexion

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

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

• Goniometer- Ankle ROM- Plantarflexion

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

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

• 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

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

Secondary Outcomes (1)

• Lower Extremity Functional Scale (LEFS)

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

Study Arms (2)

Interventional Group- OMM- Muscle energy

EXPERIMENTAL

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

Procedure: Experimental: Interventional Group- OMM- Muscle energy

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

SHAM COMPARATOR

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.

Procedure: Sham- Light touch, not reaching restrictive barrier

Interventions

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.

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

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.

Interventional Group- OMM- Muscle energy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

NYIT College of Osteopathic Medicine

Old Westbury, New York, 11568, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Sheldon Yao, DO

CONTACT

516-686-1300; syao@nyit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Professor OMM Department

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: June 1, 2023
• Study Start: July 6, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)