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

Primary Purpose

Knee Arthroscopy, Knee Arthroplasty, Osteopathic Manipulative Treatment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OMT
Sponsored by
Midwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthroscopy

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • MidwesternU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

6 months + post knee surgery

Arm Description

: 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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Full Information

First Posted
September 30, 2022
Last Updated
May 18, 2023
Sponsor
Midwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05580640
Brief Title
Investigating the Efficacy of Osteopathic Manipulative Treatment on Gait Dysfunction Following Knee Surgery
Official Title
Investigating the Efficacy of Osteopathic Manipulative Treatment on Gait Dysfunction Following Knee Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Midwestern University

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthroscopy, Knee Arthroplasty, Osteopathic Manipulative Treatment, Gait, Unsteady

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6 months + post knee surgery
Arm Type
Experimental
Arm Description
: 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.
Intervention Type
Procedure
Intervention Name(s)
OMT
Intervention 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
Primary Outcome Measure Information:
Title
Acute effect of one OMT session on gait
Description
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).
Time Frame
Acute 1hr
Title
Effect of four OMT sessions on gait
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral knee arthroscopy completed > 6 months ago with complete post-operative rehabilitation. Able to walk for 5-10 minutes on level ground. Exclusion Criteria: 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.
Facility Information:
Facility Name
MidwesternU
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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