Recruiting

OMM

Sponsor:

New York Institute of Technology

Code:

NCT05884944

Conditions

Parkinson Disease

Osteopathy in Diseases Classified Elsewhere

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sham- Light touch, not reaching restrictive barrier

Experimental: Interventional Group- OMM- Muscle energy

Study Details

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

Study ID

NCT05884944

Start date

Jul 6, 2023

Status verified date

Aug, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional Group- OMM- Muscle energy

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

sham comparator: Control Group- 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.

Interventions

Sham- Light touch, not reaching restrictive barrier

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

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

  • Mechanical stress via the MyotonPro [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Dynamic Stiffness via the MyotonPro [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Step Cycle time via the Biodex Gait Trainer 3 [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Average step length via the Biodex Gait Trainer 3 [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Step Symmetry- time on each foot via the Biodex Gait Trainer 3 [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Goniometer- Hip ROM (Flexion and Extension) [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Goniometer- Hip ROM Flexion [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Goniometer- Hip ROM Extension [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Goniometer- Knee ROM - Flexion [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Goniometer- Knee ROM - Extension [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Goniometer- Ankle ROM- Dorsiflexion [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • Goniometer- Ankle ROM- Plantarflexion [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]
  • The Timed Up & Go- 3 Meter walk [ Time Frame: Pre and Post intervention(1 hour)- change is being assessed ]

Central Contacts and Locations

Central contacts

Sheldon Yao, DO

516-686-1300syao@nyit.edu

Locations

NYIT College of Osteopathic Medicine

Recruiting

Old Westbury, New York, United States, 11568

Contacts

Sheldon Yao, DO

516-686-1300sheldon.yao@nyit.edu

More Information

Sponsor

New York Institute of Technology

Last update posted

Aug 7, 2024

Last verified

Aug, 2024

Keywords

  • Osteopathic Manipulative Medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Institute of Technology on 2024-08-07.