Investigating the Efficacy of Osteopathic Manipulative Treatment on Gait Dysfunction Following Knee Surgery
Condition: Knee Arthroscopy; Knee Arthroplasty; Osteopathic Manipulative Treatment; Gait, Unsteady
MeSH terms: Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      For patients with a history of knee surgery, especially knee arthroplasty, the persistence of
      abnormal gait kinematics is a frequently encountered issue that can hinder their ability to
      return to normal daily living.

      Muscular imbalances and leg length discrepancy (LLD) following knee arthroplasty can impact a
      patient's ability to return to a normal gait pattern. In a study of 98 patients who underwent
      total knee arthroplasty, leg lengthening on the side of the operative knee was reported in
      83% of patients as determined by comparing pre- and postoperative leg-length radiographs
      (Lang JE et al; J. Arthroplasty. 2012;27(3):341-346). LLD can lead to compensations in
      surrounding joints, muscles, and myofascial structures. Compensatory musculoskeletal changes,
      including changes in pelvic tilt and curvature of the lumbar spine can alter gait mechanics,
      lead to mechanical low back pain, and increase the risk of degenerative disc disease (Sheha
      EDM et al; J. Bone and Joint Surgery, Inc. 2018;6(8)(e6)). In addition, neurologic
      compensations can occur and include changes in muscular timing and muscular activation
      patterns. The mainstay of gait rehabilitation following knee surgery is physical therapy (PT)
      (O'Connor DP et al; J Orthop Sports Phys Ther. 2001;31(7):340-352), where LLD can be
      addressed with heel lift therapy. The use of Osteopathic Manipulative Treatment (OMT) to
      address chronic compensatory musculoskeletal changes following knee surgery in order to
      improve gait has not been extensively studied. Both OMT and PT have been shown to improve
      gait imbalances in a variety of neurological conditions such as Parkinson's disease, multiple
      sclerosis, and Prader-Willi syndrome. Previous studies of these neurologic conditions have
      demonstrated increases in walking velocity, step length, stride length and range of motion of
      the lower extremities following OMT. It remains to be determined whether OMT can improve gait
      pattern abnormalities caused by compensatory musculoskeletal patterns that persistent after
      traditional postoperative knee rehabilitation.

      The purpose of this study is to determine if OMT of chronic, compensatory, musculoskeletal
      issues associated with knee surgery improves gait parameters. In addition to providing
      objective parameters to assess and validate OMT, future patients recovering from knee surgery
      might benefit from OMT
    

Detailed description: 
      Study Design: For this proof-of-concept study we will use a series of case studies. This will
      allow us to determine if a single session of OMT can improve gait in subjects with prior knee
      surgery, whether multiple sessions are required to change chronic compensatory
      musculoskeletal issues, and whether subtle gait anomalies (or improvements), in patients with
      knee arthroscopy can be detected with the gait analysis system. If the data support our
      hypothesis, we will request an amendment to the IRB to expand subject numbers and include a
      control group. Location: MWU Multi-Specialty Clinic Overall Protocol: Informed consent
      participants will first complete a Knee Outcome Survey, undergo preintervention evaluation of
      quadriceps strength, knee range of motion, and leg length. Participants will then undergo
      gait analysis. An Osteopathic physician (KPH) will then diagnose and treat somatic
      dysfunction.

      After OMT, subjects will repeat clinical measures (quadriceps strength, knee ROM, and leg
      length) and gait analysis to determine the acute effects of OMT. Because chronic compensatory
      musculoskeletal issues may not be resolved with one session of OMT, subjects will return to
      the Multi-Specialty Clinic (MSC) for OMT

      1x/wk for 2wks. During the fourth week, subjects will repeat the pre-intervention evaluation
      and gait analysis before and after the fourth and final OMT session. In total, subjects will
      undergo four gait analysis sessions: two evaluations during the first encounter and two
      during the fourth week of the study. Detailed protocols for data collection are listed below.
      Knee Outcome Survey - Activities of Daily Living (KOS-ADL) will be used to measure each
      subject's current symptoms and functional limitations before and after participation in the
      study. The KOS-ADL is a
    

Intervention name(s): OMT
Intervention type(s): Procedure
Intervention description(s): For this proof-of-concept study we will use a series of case studies. This will allow us to determine if a single session of OMT can improve gait in subjects with prior knee surgery, whether multiple sessions are required to change chronic compensatory musculoskeletal issues, and whether subtle gait anomalies (or improvements), in patients with knee arthroscopy can be detected with the gait analysis system
Intervention model: Single Group Assignment
Intervention model description: For this proof-of-concept study we will use a series of case studies. This will allow us to determine if a single session of OMT can improve gait in subjects with prior knee surgery, whether multiple sessions are required to change chronic compensatory musculoskeletal issues, and whether subtle gait anomalies (or improvements), in patients with knee arthroscopy can be detected with the gait analysis system.
Masking: None (Open Label)
Primary purpose: Treatment