An interventional study of Gait-Modifying Shoe Intervention in Knee Osteoarthritis, Knee Pain Chronic and Knee Pain Arthritis, sponsored by Scientific Motion Technologies, Inc.. Completed. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Scientific Motion Technologies, Inc. · Interventional and Treatment
The goal of this clinical trial is to determine if gait-modification therapy via custom shoe intervention can reduce knee pain and improve gait parameters in individuals experiencing chronic (>6 month) knee pain. The main questions it aims to answer are:
Participants will:
Gait modification may reduce pain and slow the progression of medial compartment knee OA. Several biomechanical gait modification interventions to reduce the peak KAM have been tested. The strategies include changing medial-lateral trunk sway and changing toe-in or toe-out. Medial knee thrust, medial weight transfer and wider steps may also reduce knee load based on results of individual studies. Limitations to the translation of these methods to the general OA population include the challenges of teaching people to perform a modified walking pattern and the challenges of maintaining said gait changes during activities of daily life. It remains unclear whether these gait-retraining methods can result in lasting benefits or translate to better functionality, decreased pain, and improved quality of life. The longer-term effects are not well understood. Moreover, most of these interventions are not geared toward optimizing one's own neuromuscular control about the knee joint.
A possible method to achieve better neuromuscular control and reduce the peak KAM in people with medial compartment knee OA is to use gait-modifying shoes that create instability while walking. Use of these gait-modifying shoes may effectively reduce knee pain through motor learning and adaptations in one's own neuromuscular control.
The investigators will study the prototype gait-modifying design to determine whether differential pain and gait responsiveness to these gait-modifying shoe design occurs. It is not currently known how the motion and joint moments of the lower extremity joints above and below the knee are impacted with these types of shoes. This is an unfortunate scientific deficit because motion at the knee is controlled in part by motion at the hips and ankles. As such, the investigators seek to determine how these gait-modifying shoes impact the kinematic chain. They also seek to understand how gait-modifying shoes change spatiotemporal gait metrics over time. Finally, the investigators want to determine how the magnitude of pain relief obtained with gait-modifying shoes relates to joint mechanics and to subjective pain interference, a patient-focused outcome that represents value of the treatment. Data are scarce with respect to the acute and training-induced changes in kinematics and muscle activation that can occur with gait-modifying shoes. This study will address this deficit by examining the acute effect of wearing gait-modifying shoes and then examine the training-induced effect by having participants wear them at home and returning at 4, 8, and 12 weeks after the initial acute study.
These findings can guide the investigators on an eventual treatment protocol and ideal follow-up intervals as well as length of treatment. The goal is to provide information to practitioners and therapists so they may use gait-modifying shoe intervention programs and treatment expectations for the population with moderate knee OA.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.
This study's enrollment of 42 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →This is the only study on the registry with Scientific Motion Technologies, Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study will enroll approximately 30 participants who experience chronic knee pain. Participants will receive a thorough physical assessment which will be utilized to determine an individualized gait-modifying shoe intervention (according to pre-designed methodology) to alleviate knee pain and improve gait parameters. The intervention will last for 12 weeks, during which participants will wear the shoes daily as prescribed with progressive increase in usage. Follow-up assessments will be conducted at 4, 8, and 12 weeks to evaluate changes in patient-reported outcomes and gait parameters, as well as to modify usage prescription per patient tolerance.
Device: Gait-Modifying Shoe Intervention
The intervention involves the use of specially designed shoes intended to modify the wearer's gait. These shoes feature specific design elements aimed at reducing knee pain and improving overall gait mechanics and spatiotemporal parameters. The shoes will be modified using a one piece attachment altered systematically on a measured XYR control panel based on individual patient presentation upon assessment to optimize gait mechanics and minimize pain with ambulation. Participants will be instructed to wear the shoes for increasing periods each day over the 12-week period. Knee pain will be assessed using validated questionnaires, and gait parameters will be measured using motion capture technology at each follow-up visit.
Change in Knee Pain
The severity of knee pain (average) over the previous 24 hours will be self-reported with the use of an 11-point numerical pain rating scale (NRSpain) with anchors of 0, indicating no pain, and 10, indicating the worst possible pain. Night knee pain (average when in bed) from the previous night will also be reported by the patient on the same scale. These pain scales will be taken with the instruction: "0 meaning you have no pain and 10 being the worst pain imaginable-you need to go to the emergency room". If a patient answers a 10 they will be asked to confirm the score with the understanding that means there is no possible way the pain they are describing could get worse. These pain scores will be taken at each follow up visit. An MCID is accepted as a 2 point change on this scale.
Time frame: Initial assessment through week 12
Changes in Gait Parameter - Gait Speed
The change in average gait speed will be assessed using (week 12 speed) - (initial speed) with a positive number indicating an increased average gait speed and a negative indicating a decrease in average gait speed. 110-140cm/sec is an accepted average range for normal gait speed.
Time frame: Initial assessment through week 12
Changes in Gait Parameter - Step Length
Change in step length will be calculated by averaging the change in both the L and R step length using the formula (week 12 step length) - (initial step length). A positive number indicates an increase in step length and a negative number indicates a decrease in step length. An increase in step length can be evidence that a person is comfortable spending more time on a single limb allowing a longer contralateral step to be taken. This usually coincides with a decrease in pain that allows the person to be comfortable spending more time on a single limb. 55-70cm is an average normative range for step length stratified by height for normalcy.
Time frame: Initial assessment through week 12
Changes in Gait Parameter - Single Limb Support Percent
Single limb support (SLS) accepted normal range is between 38.5 - 40.5%. In general a higher SLS percentage is indicative of appropriate tolerance of load on a single limb. In painful knees you often see a single limb support percentage below the standard range due to a desire to spend less time with load through the painful joint.
Time frame: Initial assessment through week 12
Participants will be recruited from individual sites through corresponding physicians at outpatient clinical visits. The physicians on the protocol (after deeming a patient appropriate) will ask whether the candidate is interested and provide the protocol and IFC as well as contact information for the study coordinators that the patients can call to be screened and qualified for enrollment.
| Milestone | Experimental: Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Started | 42 |
| Completed | 32 |
| Not completed | 10 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Physician decision | 4 |
The severity of knee pain (average) over the previous 24 hours will be self-reported with the use of an 11-point numerical pain rating scale (NRSpain) with anchors of 0, indicating no pain, and 10, indicating the worst possible pain. Night knee pain (average when in bed) from the previous night will also be reported by the patient on the same scale. These pain scales will be taken with the instruction: "0 meaning you have no pain and 10 being the worst pain imaginable-you need to go to the emergency room". If a patient answers a 10 they will be asked to confirm the score with the understanding that means there is no possible way the pain they are describing could get worse. These pain scores will be taken at each follow up visit. An MCID is accepted as a 2 point change on this scale.
| Scores on a scale | Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| NRS 24H Pain - Baseline | 5 ± 2 |
| NRS 24H Pain - 12 weeks | 3 ± 2 |
| NRS Night Pain - Baseline | 4 ± 2 |
| NRS Night Pain - 12 weeks | 2 ± 3 |
The change in average gait speed will be assessed using (week 12 speed) - (initial speed) with a positive number indicating an increased average gait speed and a negative indicating a decrease in average gait speed. 110-140cm/sec is an accepted average range for normal gait speed.
| cm/s | Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Gait Speed Barefoot - Baseline | 98 ± 15 |
| Gait Speed Barefoot - 12 weeks | 112 ± 18 |
| Gait Speed Shod - Baseline | 105 ± 16 |
| Gait Speed Shod - 12 weeks | 116 ± 18 |
Change in step length will be calculated by averaging the change in both the L and R step length using the formula (week 12 step length) - (initial step length). A positive number indicates an increase in step length and a negative number indicates a decrease in step length. An increase in step length can be evidence that a person is comfortable spending more time on a single limb allowing a longer contralateral step to be taken. This usually coincides with a decrease in pain that allows the person to be comfortable spending more time on a single limb. 55-70cm is an average normative range for step length stratified by height for normalcy.
| cm | Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Step Length Barefoot - Baseline | 55 ± 7 |
| Step Length Barefoot - 12 weeks | 59 ± 8 |
| Step Length Shod - Baseline | 60 ± 7 |
| Step Length Shod - 12 weeks | 63 ± 8 |
Single limb support (SLS) accepted normal range is between 38.5 - 40.5%. In general a higher SLS percentage is indicative of appropriate tolerance of load on a single limb. In painful knees you often see a single limb support percentage below the standard range due to a desire to spend less time with load through the painful joint.
| Percentage | Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Single Limb Support Barefoot - Baseline | 32 ± 3 |
| Single Limb Support Barefoot - 12 weeks | 34 ± 3 |
| Single Limb Support Shod - Baseline | 35 ± 4 |
| Single Limb Support Shod - 12 weeks | 36 ± 3 |
Collected over Adverse event data was collected for each participant from their baseline visit at week 0 through their final study visit at week 12. The study began enrolling on January 3rd 2025 and the last subject had their last study visit on October 8th 2025.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Single Arm - Gait-Modifying Shoe Intervention | 0/42 (0%) | 1/42 (2.4%) | 1/42 (2.4%) |
| Event | Experimental: Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Gall Bladder Obstruction SurgeryHepatobiliary disorders | 1/42 |
| Event | Experimental: Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Back Pain Flare UpMusculoskeletal and connective tissue disorders | 1/42 |
42 subjects completed enrollment and were assigned a subject number. Some baseline characteristics such as age were collected but subject was then disqualified for participation due to other circumstances such as stability concerns.
| Age, Continuous(Number of years) | Experimental: Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Mean | 69 ± 9 |
| Sex: Female, Male(Participants) | Experimental: Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Female | 24 |
| Male | 18 |
| Race and Ethnicity Not Collected(Participants) | Experimental: Single Arm - Gait-Modifying Shoe Intervention |
|---|
| Height(Centimeters) | Experimental: Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Mean | 171 ± 9 |
| Mass(kilograms) | Experimental: Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Mean | 84 ± 19 |
| BMI(kg/m^2) | Experimental: Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Mean | 28 ± 6 |
| Kellgren-Lawrence Score(score on a scale) | Experimental: Single Arm - Gait-Modifying Shoe Intervention |
|---|---|
| Mean | 3 ± 1 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2025 to primary completion in Oct 2025, 9 months.
Results were first posted in Nov 2026, 1 year after primary completion.
Of 140 industry-sponsored interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 9 months is below that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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