Osteoarthritis, KneeNCT06208631
Effects of Movement Retraining on Knee Loading in Individuals With Knee Osteoarthritis
A study testing Gait retraining in people with Osteoarthritis, Knee, run by Stanford University at 1 site in United States.
Trial summary
This study investigates how well individuals with knee osteoarthritis can learn to alter their calf muscle activation using haptic biofeedback while walking and evaluates how these changes affect knee loading. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Gait retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medial and/or lateral compartment knee osteoarthritis
- Diagnosed with knee osteoarthritis of at least six months duration
- Ambulatory without aids
- Able to walk for at least 60 minutes
- Typical pain rating of 1-4 on scale of 0-10
- Able to reduce gastrocnemius muscle activation by 10% from baseline
Who cannot join
- History of symptomatic arthritis in lower limb joints other than the knees
- Replacement of any lower extremity joint
- Symptoms originating from the patellofemoral joint
- Body mass index equal to or greater than 35
- Nerve or muscle disease associated with walking difficulty
- History of rheumatoid arthritis, gout, or autoimmune disease
- History of lower limb fracture or surgery requiring hospitalization
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Human Performance Lab
Stanford, California, 94305
Scott D Uhlrich, PhD, 650-721-2547, oawalking@lists.stanford.edu
About this study
Official title: Effects of Haptic Movement Retraining on Osteoarthritis Progression
This study investigates how well individuals with knee osteoarthritis can learn to alter their calf muscle activation using haptic biofeedback while walking and evaluates how these changes affect knee loading.
Prior research has utilized musculoskeletal simulations to determine that reducing the activation of one of the calf muscles, the gastrocnemius, can have a large impact on reducing knee loading. However, this has not been tested in individuals with knee osteoarthritis. In this study, participants will be trained to alter the activation of their gastrocnemius muscle, by receiving haptic feedback after each step. The feedback will indicate how the participant changed their muscle activation relative to baseline. Some participants will train on a treadmill in the laboratory for up to two sessions, with 30 minutes of walking with feedback in each session. If a participant can learn to adjust their muscle activation in the first training session, they will be able to complete the second training session. Other participants will train outside the laboratory for one session with 30 minutes of walking with feedback to investigate changes in knee loading while using the new walking strategy during over-ground walking.
The movement data collected during the training sessions will be used as inputs to computer simulations of the musculoskeletal system to determine if walking with the new muscle activation strategy reduces knee loading.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Gait retraining
- 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 retrainingBehavioural
Changing muscle coordination while walking
| Study group | Role | What they receive |
|---|---|---|
| Gait modification | Experimental | Participants will learn to change muscle coordination while walking through real-time haptic biofeedback based on the activation of the gastrocnemius muscle Receives: Behavioral: Gait retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in knee contact force
Knee contact force will be evaluated using motion capture data and musculoskeletal modeling and simulations, for participants that are able to reduce gastrocnemius activation.
Measured: Evaluated during the 30 minutes of feedback walking in the second in-lab session and out-of-lab session
Secondary outcomes (3)
Change from baseline in gastrocnemius activation
Gastrocnemius activation measured through EMG signals.
Measured: Evaluated during the 30 minutes of feedback walking in the first in-lab session, the second in-lab session, and the out-of-lab session
Proportion of participants that reduce gastrocnemius activation
Gastrocnemius activation will be measured through electromyography (EMG) signals, and the muscle activation during gait retraining will be compared to baseline walking. Participants that can reduce gastrocnemius activation 10% or more from baseline within 30 minutes of gait retraining will be counted as participants that can reduce gastrocnemius activation out of the total number of participants who try the gait retraining.
Measured: Evaluated during the 30 minutes of feedback walking in the first in-lab session, the second in-lab session, and the out-of-lab session
Proportion of participants that reduce knee contact force
For the participants who can successfully reduce gastrocnemius activation from baseline, knee contact force will be calculated using motion capture data and musculoskeletal modeling and simulations. The proportion of participants that reduce knee contact force from baseline during gait retraining out of the total participants that reduce gastrocnemius activation will be evaluated.
Measured: Evaluated during the 30 minutes of feedback walking in the second in-lab session and the out-of-lab session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start18 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Delp, Stanford University
- Investigators
- Scott L Delp, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208631
- Sponsor's protocol ID
- 34928
- Status last verified
- Oct 2025
- First submitted
- 18 Dec 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified experimental data and simulation results will be made available.
Publications
Uhlrich SD, Jackson RW, Seth A, Kolesar JA, Delp SL. Muscle coordination retraining inspired by musculoskeletal simulations reduces knee contact force. Sci Rep. 2022 Jul 7;12(1):9842. doi: 10.1038/s41598-022-13386-9.
PubMed 35798755Demers MS, Pal S, Delp SL. Changes in tibiofemoral forces due to variations in muscle activity during walking. J Orthop Res. 2014 Jun;32(6):769-76. doi: 10.1002/jor.22601. Epub 2014 Feb 26.
PubMed 24615885
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Haptic Movement Retraining on Osteoarthritis Progression
- ClinicalTrials.gov ID
- NCT06208631
- Acronym / sponsor ID
- 34928
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jan 2024 (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 study investigates how well individuals with knee osteoarthritis can learn to alter their calf muscle activation using haptic biofeedback while walking and evaluates how these changes affect knee loading.
Prior research has utilized musculoskeletal simulations to determine that reducing the activation of one of the calf muscles, the gastrocnemius, can have a large impact on reducing knee loading. However, this has not been tested in individuals with knee osteoarthritis. In this study, participants will be trained to alter the activation of their gastrocnemius muscle, by receiving haptic feedback after each step. The feedback will indicate how the participant changed their muscle activation relative to baseline. Some participants will train on a treadmill in the laboratory for up to two sessions, with 30 minutes of walking with feedback in each session. If a participant can learn to adjust their muscle activation in the first training session, they will be able to complete the second training session. Other participants will train outside the laboratory for one session with 30 minutes of walking with feedback to investigate changes in knee loading while using the new walking strategy during over-ground walking.
The movement data collected during the training sessions will be used as inputs to computer simulations of the musculoskeletal system to determine if walking with the new muscle activation strategy reduces knee loading.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait modification | Experimental | Behavioral: Gait retrainingParticipants will learn to change muscle coordination while walking through real-time haptic biofeedback based on the activation of the gastrocnemius muscle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Medial and/or lateral compartment knee osteoarthritis
- Diagnosed with knee osteoarthritis of at least six months duration
- Ambulatory without aids
- Able to walk for at least 60 minutes
- Typical pain rating of 1-4 on scale of 0-10
Key exclusion criteria (8 listed)
- History of symptomatic arthritis in lower limb joints other than the knees
- Replacement of any lower extremity joint
- Symptoms originating from the patellofemoral joint
- Body mass index equal to or greater than 35
- Nerve or muscle disease associated with walking difficulty
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 retrainingChanging muscle coordination while walking | Behavioural | Gait modification |
Primary outcome
Change from baseline in knee contact force
Time frame: Evaluated during the 30 minutes of feedback walking in the second in-lab session and out-of-lab session
Knee contact force will be evaluated using motion capture data and musculoskeletal modeling and simulations, for participants that are able to reduce gastrocnemius activation.
3 secondary outcomes
Change from baseline in gastrocnemius activation
Time frame: Evaluated during the 30 minutes of feedback walking in the first in-lab session, the second in-lab session, and the out-of-lab session
Proportion of participants that reduce gastrocnemius activation
Time frame: Evaluated during the 30 minutes of feedback walking in the first in-lab session, the second in-lab session, and the out-of-lab session
Proportion of participants that reduce knee contact force
Time frame: Evaluated during the 30 minutes of feedback walking in the second in-lab session and the out-of-lab session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 35798755Uhlrich SD, Jackson RW, Seth A, Kolesar JA, Delp SL. Muscle coordination retraining inspired by musculoskeletal simulations reduces knee contact force. Sci Rep. 2022 Jul 7;12(1):9842. doi: 10.1038/s41598-022-13386-9.
- Background: PubMed 24615885Demers MS, Pal S, Delp SL. Changes in tibiofemoral forces due to variations in muscle activity during walking. J Orthop Res. 2014 Jun;32(6):769-76. doi: 10.1002/jor.22601. Epub 2014 Feb 26.
- Individual participant dataSharing planned: Yes. De-identified experimental data and simulation results will be made available.
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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.
Scott L Delp, PhD principal investigator
Stanford 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 retraining in people with Osteoarthritis, Knee, run by Stanford 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 6 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: looking for participants now, as of the sponsor's last update on 23 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Team (650-721-2547, oawalking@lists.stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in knee contact force (time frame: Evaluated during the 30 minutes of feedback walking in the second in-lab session and out-of-lab session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06208631, which also lists 2 linked publications.
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 23 Jun 2026.