Investigating the Efficacy of Osteopathic Manipulative Treatment on Gait Dysfunction Following Knee Surgery

NCT05580640 | Completed

• 1 other identifier: IRB: 21053
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Knee Arthroscopy; Knee Arthroplasty; Osteopathic Manipulative Treatment; Gait, Unsteady

Outcome Measures

Primary Outcomes (2)

• Acute effect of one OMT session on gait

  We hypothesize one Osteopathic Manipulative Treatment (OMT) session will increase walking speed and motion efficiency between the operative and non-operative leg in patients with a history of knee surgery. Gait analysis will quantify differences in force and motion, in space and time (spatiotemporal kinetics and kinematics).

  Acute 1hr

• Effect of four OMT sessions on gait

  Patients with knee arthroplasty may have chronic somatic dysfunction that requires several OMT sessions to have an effect. We hypothesize four sessions of Osteopathic Manipulative Treatment (OMT) will increase walking speed and motion efficiency between the operative and non-operative leg in patients with a history of knee surgery. Gait analysis will quantify differences in force and motion, in space and time (spatiotemporal kinetics and kinematics).

  4 weeks

Study Arms (1)

6 months + post knee surgery

EXPERIMENTAL

: For study participation subjects need a history of unilateral knee arthroscopy or arthroplasty performed \> 6 months ago with completion of post-operative rehabilitation. Subjects will be between the ages of 21 and 90 years old and the ability to walk for 5-10 minutes on level ground.

Procedure: OMT

Interventions

OMT PROCEDURE

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

6 months + post knee surgery

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral knee arthroscopy completed \> 6 months ago with complete post-operative rehabilitation.
• Able to walk for 5-10 minutes on level ground.

You may not qualify if:

• Pregnancy
• Subjects with vestibular impairments or cardiovascular disease
• Inability to walk without the aid of an assistive device (e.g., walker, cane),
• History of neurological disorders including multiple sclerosis, Parkinson's disease or stroke causing gait impairment
• Subjects with additional joint replacements, spinal fusions, or a history of hip, ankle, or foot surgery.

Sponsors & Collaborators

• Midwestern University: lead

Study Sites (1)

MidwesternU

Downers Grove, Illinois, 60515, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 14, 2022
• Study Start: August 30, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 19, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)