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Knee OsteoarthritisNCT06598696

Biomechanical and Clinical Evaluation of a Gait Modifying Device for Treating Knee Pain

A study testing Gait-Modifying Shoe Intervention in people with Knee Osteoarthritis and Knee Pain Chronic, run by Scientific Motion Technologies, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 85 years
What is being tested?
Gait-Modifying Shoe Intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
3 Jan 2025to 8 Oct 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be at least 40 years of age, but no more than 85 years of age at time of consent, of any sex or race;
  • Have chronic, moderate, osteoarthritic-related knee pain occurring with ambulation;
  • NRS Pain score reaches between 4/10 or greater 4+ days a week, as assessed by practitioner;
  • Have a Kellgren and Lawrence score of 2,3, or 4, as demonstrated by x-ray within the last 2 years;
  • Be able to walk unassisted for at least 10 minutes at a time;
  • Wear a women's shoe size of U.S. 7 to 14 or a men's shoe size of U.S. 6 to 13;
  • Not currently enrolled in a supervised physical therapy program for knee pain;
  • Have access and ability to use a smart phone.

Who cannot join

  • Be diagnosed with acute septic or inflammatory arthritis;
  • Be considered a High Fall Risk (3+ falls in last year, TUG >21 seconds, TURN180 >4 steps)
  • Have unstable cardiovascular, orthopedic, or neurological conditions, uncontrolled diabetes, or any condition that would preclude exercise in moderate duration, or moderate workload trials;
  • Have received a corticosteroid injection for knee pain or invasive procedures within prior 3 months of the study;
  • Have history of avascular necrosis in the knee;
  • Have experienced more than 3 falls within the last year;
Show all 15Show fewer
  • Have a pathological osteoporotic fracture;
  • Have severe symptomatic degenerative arthritis in lower limb joints other than the knees;
  • Have severe back pain, prior spinal fusion, or spinal deformity that would affect gait;
  • Have major cardiac or pulmonary conditions and any orthopedic limitation that precludes your ability to independently walk for 10 minutes or longer;
  • Have any major surgery to either knee within the prior 12 months;
  • Be currently enrolled in a supervised physical therapy program;
  • Be currently using any knee brace on a regular basis for knee pain, with the exception of basic knee sleeves;
  • Have previous partial knee joint replacement;
  • Have previous total knee joint replacement.

About this study

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:

  • Do patient-reported outcomes related to knee pain improve with the use of gait-modifying shoes?
  • Do gait-modifying shoes change gait parameters (speed, step length, single limb support, and symmetry)?
Read more

Participants will:

  • Attend an initial assessment and treatment visit lasting less than 2 hours.
  • Wear gait-modifying shoes daily for 12 weeks, gradually increasing the duration of wear as prescribed.
  • Record the daily time worn and pain levels on a provided chart.
  • Attend three follow-up visits, each lasting less than 1 hour, for treatment adjustments and data collection.
Read the detailed description

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.

Being tested
Gait-Modifying Shoe Intervention
Keywords
gait modification, gait retraining, knee pain therapy
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-Modifying Shoe InterventionDevice

    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.

Study groups in NCT06598696
Study groupRoleWhat they receive
Single Arm - Gait-Modifying Shoe InterventionExperimentalThis 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.
Receives: Device: Gait-Modifying Shoe Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Initial assessment through week 12

  2. 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.

    Measured: Initial assessment through week 12

  3. 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.

    Measured: Initial assessment through week 12

  4. 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.

    Measured: Initial assessment through week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start3 Jan 2025
  3. Primary completion8 Oct 2025
  4. Study completion8 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06598696
Sponsor's protocol ID
SMT202401
Status last verified
Oct 2026
First submitted
9 Sep 2024
Last updated
2 Nov 2026
Data monitoring committee
No
Individual data sharing
No

Publications

  • Zeighami A, Dumas R, Aissaoui R. Knee loading in OA subjects is correlated to flexion and adduction moments and to contact point locations. Sci Rep. 2021 Apr 21;11(1):8594. doi: 10.1038/s41598-021-87978-2.

    PubMed 33883591

  • Silva MDC, Perriman DM, Fearon AM, Tait D, Spencer TJ, Walton-Sonda D, Simic M, Hinman RS, Bennell KL, Scarvell JM. Effects of neuromuscular gait modification strategies on indicators of knee joint load in people with medial knee osteoarthritis: A systematic review and meta-analysis. PLoS One. 2022 Sep 21;17(9):e0274874. doi: 10.1371/journal.pone.0274874. eCollection 2022.

    PubMed 36129904

  • Reichenbach S, Felson DT, Hincapie CA, Heldner S, Butikofer L, Lenz A, da Costa BR, Bonel HM, Jones RK, Hawker GA, Juni P. Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial. JAMA. 2020 May 12;323(18):1802-1812. doi: 10.1001/jama.2020.3565.

    PubMed 32396180

  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PubMed 1991946

  • Netukova S, Horakova L, Szabo Z, Krupicka R. Beyond timing and step counting in 360 degrees turning-in-place assessment: a scoping review. Biomed Eng Online. 2024 Jan 31;23(1):13. doi: 10.1186/s12938-024-01208-0.

    PubMed 38297359

  • Miyazaki T, Wada M, Kawahara H, Sato M, Baba H, Shimada S. Dynamic load at baseline can predict radiographic disease progression in medial compartment knee osteoarthritis. Ann Rheum Dis. 2002 Jul;61(7):617-22. doi: 10.1136/ard.61.7.617.

    PubMed 12079903

  • He Y, Li Z, Alexander PG, Ocasio-Nieves BD, Yocum L, Lin H, Tuan RS. Pathogenesis of Osteoarthritis: Risk Factors, Regulatory Pathways in Chondrocytes, and Experimental Models. Biology (Basel). 2020 Jul 29;9(8):194. doi: 10.3390/biology9080194.

    PubMed 32751156

  • Gupta D, Donnelly CJ, Reinbolt JA. Finding Emergent Gait Patterns May Reduce Progression of Knee Osteoarthritis in a Clinically Relevant Time Frame. Life (Basel). 2022 Jul 14;12(7):1050. doi: 10.3390/life12071050.

    PubMed 35888138

  • Goryachev Y, Debbi EM, Haim A, Wolf A. The effect of manipulation of the center of pressure of the foot during gait on the activation patterns of the lower limb musculature. J Electromyogr Kinesiol. 2011 Apr;21(2):333-9. doi: 10.1016/j.jelekin.2010.11.009. Epub 2011 Jan 6.

    PubMed 21215655

  • Goryachev Y, Debbi EM, Haim A, Rozen N, Wolf A. Foot center of pressure manipulation and gait therapy influence lower limb muscle activation in patients with osteoarthritis of the knee. J Electromyogr Kinesiol. 2011 Oct;21(5):704-11. doi: 10.1016/j.jelekin.2011.05.001.

    PubMed 21684760

  • Gamerman Y, Hoshen M, Herman Cohen A, Alter Z, Hadad L, Melzer I. Validity and Inter-observer Reliability of the TURN 180 Test to Identify Older Adults Who Reported Falls. Isr Med Assoc J. 2019 Apr;21(4):269-274.

    PubMed 31032570

  • Fregly BJ, Reinbolt JA, Rooney KL, Mitchell KH, Chmielewski TL. Design of patient-specific gait modifications for knee osteoarthritis rehabilitation. IEEE Trans Biomed Eng. 2007 Sep;54(9):1687-95. doi: 10.1109/tbme.2007.891934.

    PubMed 17867361

  • Drexler M, Elbaz A, Mor A, Debi R, Debbi EM, Haim A, Lador R, Salai M, Segal G. Effects of a customized biomechanical therapy on patients with medial compartment knee osteoarthritis. Ann Phys Rehabil Med. 2012 May;55(4):213-28. doi: 10.1016/j.rehab.2012.01.002. Epub 2012 Mar 27. English, French.

    PubMed 22521468

  • Collins NJ, Prinsen CA, Christensen R, Bartels EM, Terwee CB, Roos EM. Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis Cartilage. 2016 Aug;24(8):1317-29. doi: 10.1016/j.joca.2016.03.010. Epub 2016 Mar 21.

    PubMed 27012756

  • Chehab EF, Favre J, Erhart-Hledik JC, Andriacchi TP. Baseline knee adduction and flexion moments during walking are both associated with 5 year cartilage changes in patients with medial knee osteoarthritis. Osteoarthritis Cartilage. 2014 Nov;22(11):1833-9. doi: 10.1016/j.joca.2014.08.009. Epub 2014 Aug 27.

    PubMed 25211281

Questions about this trial

What is this clinical trial studying?

A study testing Gait-Modifying Shoe Intervention in people with Knee Osteoarthritis and Knee Pain Chronic, run by Scientific Motion Technologies, Inc..

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 8 inclusion and 15 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 2 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Knee Pain (time frame: Initial assessment through week 12). The study lists 4 primary outcomes in all. 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 NCT06598696, which also lists 17 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 2 Nov 2026.

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