Knee OsteoarthritisNCT04946136
Gait Modification and Knee Joint Load
A study testing Gait modification in people with Knee Osteoarthritis, run by Northwestern University at 1 site in United States.
Trial summary
This pilot study aims to assess the effect of a 6-week individualized gait retraining program on knee load and symptoms in persons with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Gait modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 30 Dec 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- people with radiographic TF OA fulfilling American College of Rheumatology classification criteria
- reporting average knee pain on walking > 3 on an 11-point scale (0-10) in at least one knee
- pain or tenderness predominantly located on the medial knee.
Who cannot join
- medial TF joint space width greater than lateral
- Kellgren/Lawrence (K/L) grade 4
- knee surgery or intra-articular corticosteroid injection in the past 6 months
- uncomfortable walking on treadmill for 20 minutes
- unable to walk without a walking aide
- inflammatory arthritis
- other musculoskeletal or neurological disorders that affect gait patterns
- currently receiving physical therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Gait Modification on Knee Joint Load in Persons With Medial Tibiofemoral Osteoarthritis - A Pilot Study
This pilot study aims to assess the effect of a 6-week individualized gait retraining program on knee load and symptoms in persons with knee osteoarthritis (OA).
Read the detailed description
This study aims to pilot-test an individualized gait retraining intervention to reduce knee load, guided by real-time visual feedback of the external knee adduction moment (KAM), a commonly used determinant for medial tibiofemoral (TF) joint load, during walking. Our central hypothesis is that individuals with predominantly medial TF OA can adapt their gait patterns to lower KAM during walking; consequently, reduce knee load and pain.
- Conditions
- Knee Osteoarthritis
- Being tested
- Gait modification
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait modificationOther
Individualized gait modifications guided by real-time visual feedback of knee load
| Study group | Role | What they receive |
|---|---|---|
| Gait modification | Experimental | In this pilot study, participants modify their gait patterns guided by real-time visual feedback on their medial knee load while walking on an instrumented treadmill. Receives: Other: Gait modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
External knee adduction moment during walking
The external knee adduction moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee adduction moment during walking.
Measured: Baseline-to-6-week change
WOMAC (Western Ontario and McMaster Universities) score
WOMAC questionnaire contains 24 questions in three domains of pain (score range 0-20), stiffness (score range 0-8) and physical function (score range 0-68). Higher score indicates worse symptom/function.
Measured: Baseline-to-6-week change
Secondary outcomes (2)
External knee flexion moment during walking
The external knee flexion moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee flexion moment during walking.
Measured: Baseline-to-6-week change
KOOS (Knee Injury and Osteoarthritis Outcome Score)
KOOS questionnaire contains 42 items in 5 domains of pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.
Measured: Baseline-to-6-week change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start11 Jan 2021
- Primary completion18 Aug 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison H Chang, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946136
- Sponsor's protocol ID
- STU00212048
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2021
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gait Modification on Knee Joint Load in Persons With Medial Tibiofemoral Osteoarthritis - A Pilot Study
- ClinicalTrials.gov ID
- NCT04946136
- Acronym / sponsor ID
- STU00212048
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 30 Jun 2021 (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.
This pilot study aims to assess the effect of a 6-week individualized gait retraining program on knee load and symptoms in persons with knee osteoarthritis (OA).
Detailed description
This study aims to pilot-test an individualized gait retraining intervention to reduce knee load, guided by real-time visual feedback of the external knee adduction moment (KAM), a commonly used determinant for medial tibiofemoral (TF) joint load, during walking. Our central hypothesis is that individuals with predominantly medial TF OA can adapt their gait patterns to lower KAM during walking; consequently, reduce knee load and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait modification | Experimental | Other: Gait modificationIn this pilot study, participants modify their gait patterns guided by real-time visual feedback on their medial knee load while walking on an instrumented treadmill. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- people with radiographic TF OA fulfilling American College of Rheumatology classification criteria
- reporting average knee pain on walking > 3 on an 11-point scale (0-10) in at least one knee
- pain or tenderness predominantly located on the medial knee.
Key exclusion criteria (8 listed)
- medial TF joint space width greater than lateral
- Kellgren/Lawrence (K/L) grade 4
- knee surgery or intra-articular corticosteroid injection in the past 6 months
- uncomfortable walking on treadmill for 20 minutes
- unable to walk without a walking aide
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 |
|---|---|---|
| Gait modificationIndividualized gait modifications guided by real-time visual feedback of knee load | Other | Gait modification |
Primary outcome
External knee adduction moment during walking
Time frame: Baseline-to-6-week change
The external knee adduction moment during walking will be assessed using a10-camera optical motion capture system and force plates. A visual 3D program will be used to compute and plot the pre- and post-intervention external knee adduction moment during walking.
WOMAC (Western Ontario and McMaster Universities) score
Time frame: Baseline-to-6-week change
WOMAC questionnaire contains 24 questions in three domains of pain (score range 0-20), stiffness (score range 0-8) and physical function (score range 0-68). Higher score indicates worse symptom/function.
2 secondary outcomes
External knee flexion moment during walking
Time frame: Baseline-to-6-week change
KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: Baseline-to-6-week change
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 26 Aug 2026.
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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.
Alison H Chang principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait modification in people with Knee Osteoarthritis, run by Northwestern 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 3 inclusion and 8 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 26 Aug 2026. 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?
External knee adduction moment during walking (time frame: Baseline-to-6-week change). 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 26 Aug 2026.