Gait Retraining for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen by Nelson Cortes

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: George Mason University

Disqualifiers: Obesity, Recent surgery, Neurological, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this proposed study is to investigate both the acute and chronic response of frontal plane knee moment after gait retraining and to assess the effects on the biomechanics of the contralateral side. Fifty-one patients diagnosed with tibiofemoral joint osteoarthritis (TFJ OA) will be recruited to participate in the proposed study. Participants will complete baseline trials to assess gait kinematic and kinetic parameters. Following baseline, each participant will perform six conditions of the foot progression gait or three conditions of the trunk lean gait modifications to determine which strategy is most effective in reducing frontal plane knee moment. Participants will then be randomized to either the control or experimental group based on their identified preferred strategy. Participants will complete eight gait retraining sessions using patient-specific gait modifications (tailored foot progression and tailored lateral trunk lean), or normal gait (control) during the training period. A fading feedback design will be implemented. Real-time haptic biofeedback will be provided on every step during the first two weeks and reduced by 25% every subsequent two weeks. No feedback will be provided during baseline and at testing sessions. Measures of pain and function will also be collected at all testing sessions. Variables of interest include ankle, knee, hip sagittal and frontal plane moments. In addition, sagittal and frontal plane impulse will also be assessed. Descriptive statistics will be calculated for foot progression angle, trunk lean angle, frontal and sagittal plane hip, knee, and ankle angles as well as moments. Descriptive statistics for frontal plane knee impulse will also be calculated. A multivariate analysis of variance (MANOVA) will be conducted to compare frontal plane knee moment, frontal plane knee impulse and the absolute sagittal plane moment will be compared across three groups at four different time points. Repeated measures analysis of variance (ANOVA) will be conducted to compare both sagittal and frontal plane joint biomechanics for the contralateral limb. The p-value will be set at .05.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Gait Retraining for Osteoarthritis?

Research shows that gait retraining can help reduce knee pain and joint load in people with knee osteoarthritis. Studies have found that adjusting walking patterns, like foot progression angle and step width, can decrease stress on the knee, potentially slowing the progression of osteoarthritis. ^{1 2 3 4 5}

Is gait retraining safe for humans?

Gait retraining has been studied in various contexts, such as reducing knee pain and impact forces in runners and people with knee osteoarthritis, without reports of adverse effects, suggesting it is generally safe for humans. ^{3 4 5 6 7}

How is the Gait Retraining treatment different from other treatments for osteoarthritis?

Gait Retraining is unique because it focuses on changing the way a person walks to reduce stress on the knee joint, using techniques like adjusting foot angles and stride length, often with real-time feedback from wearable devices. This approach is different from traditional treatments that might focus on medication or physical therapy exercises, as it directly targets the mechanics of walking to alleviate knee pain and slow the progression of osteoarthritis. ^{2 3 4 5 8}

Research Team

Nelson Cortes

Principal Investigator

Associate Professor

Eligibility Criteria

This trial is for adults aged 18-80 with knee osteoarthritis, who can walk unaided for at least 20 minutes. It's not suitable for those with a BMI over 35, recent back or leg surgery, knee treatments in the last six months, conditions affecting walking, cognitive impairments impacting motor learning, or if they use gait aids or certain orthotics.

Inclusion Criteria

I can walk by myself for at least 20 minutes.

I have been diagnosed with knee osteoarthritis by a healthcare professional.

I am between 18 and 80 years old.

Exclusion Criteria

Body mass index greater than 35

I have not had knee surgery or injections in the last 6 months.

I do not have any cognitive issues that affect my ability to learn new physical tasks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline trials to assess gait kinematic and kinetic parameters

1 week

2 visits (in-person)

Gait Retraining Intervention

Participants perform 8 gait retraining sessions using patient-specific gait modifications or normal gait

8 weeks

8 visits (in-person)

Post-Intervention Testing

Over-ground gait analysis and treadmill walking performed to track skill acquisition

1 week

2 visits (in-person)

Follow-up

Follow-up testing to measure retention of prescribed gait modifications

12 months

4 visits (in-person)

Treatment Details

Interventions

• Gait Retraining (Behavioural Intervention)

Trial Overview The study tests how changing the way participants walk (foot progression and trunk lean) affects their knee mechanics and pain. Participants will be split into groups to either receive tailored gait retraining or continue normal walking as a control group. The training includes eight sessions with decreasing feedback on their steps.

Participant Groups

Group I: Trunk Lean Experimental Treatment 1 Intervention

Participants will visualize a desired trunk lean angle bandwidth in real-time that they should target with their trunk lean angle

Group II: Foot Progression Experimental Treatment 1 Intervention

Participants will visualize a desired foot progression angle bandwidth in real-time that they should target with their foot angle

Group III: Control Active Control 1 Intervention

No intervention

Who Is Running the Clinical Trial?

George Mason University

Lead Sponsor

Trials

60

Recruited

50,200+

Dr. Ali Andalibi

George Mason University

Chief Executive Officer

PhD in Microbiology and Molecular Genetics from UCLA

Dr. Chetan S. Shah

George Mason University

Chief Medical Officer since 2013

MD from Robert Wood Johnson Medical School

Findings from Research

A custom haptic ankle bracelet successfully retrained 9 out of 10 healthy subjects to adjust their gait parameters, specifically foot progression angle and step width, with 80% accuracy during a short training session.

The study demonstrated that both feedback schemes used in the device were equally effective, as there was no significant difference in the number of steps required to complete the retraining task, suggesting the device's potential for future use in patients with knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable lower limb haptic feedback device for retraining Foot Progression Angle and Step Width. Chen, DKY., Haller, M., Besier, TF.[2018]

A wearable visual feedback system using inertial measurement units was developed for gait retraining in patients with knee osteoarthritis, showing high accuracy (2.4 degrees RMS) in tracking foot progression angle compared to traditional optical motion capture systems.

The effectiveness of the wearable system in providing biofeedback was comparable to laboratory methods, achieving about 50% success in guiding participants to maintain the target foot progression angle, suggesting it could simplify and enhance clinical adoption of gait retraining interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of wearable visual feedback for retraining foot progression angle using inertial sensors and an augmented reality headset. Karatsidis, A., Richards, RE., Konrath, JM., et al.[2019]

A gait retraining program for 30 healthy runners successfully increased their step rate by 8.6%, leading to significant reductions in impact forces and peak hip adduction, which are important for preventing injuries.

The retraining also decreased eccentric knee joint work by 26.9% during running, indicating that the program not only improved running mechanics but did so without adverse effects on knee joint function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-field gait retraining and mobile monitoring to address running biomechanics associated with tibial stress fracture. Willy, RW., Buchenic, L., Rogacki, K., et al.[2022]

A gait retraining program using mobile biofeedback effectively reduced peak and impulse tibiofemoral contact forces during running by 7.6% and 10.6%, respectively, in a study of 30 runners over 8 sessions.

These reductions in tibiofemoral contact forces were maintained even one month after the retraining, suggesting a lasting impact on knee load management without altering the knee adduction moment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in tibiofemoral contact forces during running in response to in-field gait retraining. Willy, RW., Meardon, SA., Schmidt, A., et al.[2022]

The study demonstrated that it is feasible for individuals to reduce the peak knee adduction moment (pKAM) by at least 10% without increasing the peak knee flexion moment (pKFM) through personalized gait modifications, including foot progression angle (FPA), step width (SW), and stride length (SL).

Modifying stride length (SL) was particularly effective, with seven out of eleven participants achieving the desired dual kinetic change, highlighting the importance of SL in gait retraining for knee osteoarthritis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing the ambulatory knee adduction moment without increasing the knee flexion moment individually through modifications in footprint parameters: A feasibility study for a dual kinetic change in healthy subjects. Ulrich, B., Cosendey, K., Jolles, BM., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Wearable lower limb haptic feedback device for retraining Foot Progression Angle and Step Width. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Validation of wearable visual feedback for retraining foot progression angle using inertial sensors and an augmented reality headset. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Reducing knee pain and loading with a gait retraining program for individuals with knee osteoarthritis: Protocol for a randomized feasibility trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Immediate and short-term effects of gait retraining on the knee joint moments and symptoms in patients with early tibiofemoral joint osteoarthritis: a randomized controlled trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Toe-in and toe-out gait retraining interventions to reduce proxy measures of medial knee joint load in people with medial knee osteoarthritis: Protocol for a randomised placebo-controlled trial. [2023]

6. Denmark pubmed.ncbi.nlm.nih.gov

In-field gait retraining and mobile monitoring to address running biomechanics associated with tibial stress fracture. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Changes in tibiofemoral contact forces during running in response to in-field gait retraining. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Decreasing the ambulatory knee adduction moment without increasing the knee flexion moment individually through modifications in footprint parameters: A feasibility study for a dual kinetic change in healthy subjects. [2021]