Knee ArthroscopyNCT05580640
Investigating the Efficacy of Osteopathic Manipulative Treatment on Gait Dysfunction Following Knee Surgery
A study testing OMT in people with Knee Arthroscopy and Knee Arthroplasty, run by Midwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Knee Arthroscopy, Knee Arthroplasty, Osteopathic Manipulative Treatment
- What is being tested?
- OMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral knee arthroscopy completed > 6 months ago with complete post-operative rehabilitation.
- Able to walk for 5-10 minutes on level ground.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- OMT
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMTProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start30 Aug 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580640
- Sponsor's protocol ID
- IRB: 21053
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Osteopathic Manipulative Treatment on Gait Dysfunction Following Knee Surgery
- ClinicalTrials.gov ID
- NCT05580640
- Acronym / sponsor ID
- IRB: 21053
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 6 months + post knee surgery | Experimental | Procedure: OMT: 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral knee arthroscopy completed > 6 months ago with complete post-operative rehabilitation.
- Able to walk for 5-10 minutes on level ground.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMTFor 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 | Procedure or surgery | 6 months + post knee surgery |
Primary outcome
Acute effect of one OMT session on gait
Time frame: Acute 1hr
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
Time frame: 4 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMT in people with Knee Arthroscopy and Knee Arthroplasty, run by Midwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute effect of one OMT session on gait (time frame: Acute 1hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.