Gait Rehabilitation for Knee Osteoarthritis After ACL Injury

Overseen By Natalia Favoreto, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Multiple ligament surgery, Lower extremity fracture, Knee osteoarthritis, BMI ≥ 36

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how real-time gait biofeedback can assist individuals with early knee osteoarthritis following ACL surgery. Participants receive personalized feedback while walking to improve their gait and potentially slow arthritis progression. The trial includes two groups: one receives actual feedback, while the other receives a sham version without real corrections. Ideal participants underwent ACL surgery 6–60 months ago and have completed all other physical therapy. As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery techniques for future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that real-time gait biofeedback is safe for knee osteoarthritis rehabilitation?

Research has shown that real-time gait biofeedback is generally safe for people. One study on biofeedback for knee problems found no major safety issues, and participants handled the biofeedback well. Another study, which aimed to reduce risks after ACL injuries, also found the biofeedback safe, with no serious side effects. These findings suggest that real-time gait biofeedback is likely safe to use, as previous research has reported no harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for knee osteoarthritis after an ACL injury, which often involve physical therapy and medications, real-time gait biofeedback (RTGBF) offers a cutting-edge approach by providing personalized feedback to normalize the vertical ground reaction force of each limb. This method is unique because it actively engages patients in adjusting their walking patterns in real-time, potentially improving their gait more effectively than standard therapies. Researchers are excited about this trial because it could lead to more precise and individualized rehabilitation strategies, enhancing recovery and long-term joint health for patients with knee osteoarthritis.

What evidence suggests that real-time gait biofeedback is effective for knee osteoarthritis after ACL injury?

Research has shown that real-time feedback on walking can aid people recovering from an ACL injury. In this trial, participants may receive real-time gait biofeedback, which improves movement by providing live updates on walking style, potentially leading to healthier movement patterns. One study found that this feedback reduced pain and improved function in people with knee osteoarthritis. Participants adjusted their movements immediately, leading to better results. This suggests that real-time walking feedback might ease walking and reduce pain for those with knee issues after an ACL injury. ^{1 2 3 4 6}

Who Is on the Research Team?

Brian G Pietrosimone, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-35 who have had ACL reconstruction surgery between 6 and 24 months ago, completed all physical therapy, walk with less force than usual (vGRF impact peak <1.09 x body weight), and have significant knee symptoms (KOOS-QOL <72). It's not for those with a BMI ≥36, knee osteoarthritis, history of lower extremity fractures, or multiple ligament surgeries.

Inclusion Criteria

I had ACL surgery between 6 months and 5 years ago.

I have significant knee pain or problems.

I have finished all my prescribed physical therapy sessions.

Exclusion Criteria

I am scheduled for or have had ACL revision surgery.

I have had surgery on multiple ligaments.

My BMI is 36 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive real-time gait biofeedback or sham biofeedback over a 6-week period

6 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 6 weeks and 6 months

6 months

Assessments at 6 weeks and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Real-time gait biofeedback
• Sham real-time gait biofeedback

Trial Overview The study tests the effects of real-time gait biofeedback over six weeks on early markers of FastOA in patients who've undergone ACL reconstruction. Participants will receive either actual biofeedback or sham feedback to compare outcomes at the end of treatment and after six months.

How Is the Trial Designed?

Group I: Real-time gait biofeedback (RTGBF) Active Control 1 Intervention

The RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb.

Group II: Sham real-time gait biofeedback (Sham RTGBF) Placebo Group 1 Intervention

The Sham RTGBF regimen will receive biofeedback that cues their habitual step length determined during the accommodation period on the first session of treadmill walking.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Arthritis Foundation

Collaborator

Trials

36

Recruited

46,500+

Published Research Related to This Trial

A new gait retraining method using real-time feedback of the external knee adduction moment (KAM) was tested on 16 healthy subjects, resulting in an average reduction of KAM by 20.7% compared to normal walking.

Both visual and tactile feedback were effective in helping participants adjust their gait patterns, with tactile feedback requiring more time for subjects to achieve an acceptable gait, highlighting the method's potential for improving knee health in individuals at risk for osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time knee adduction moment feedback for gait retraining through visual and tactile displays. Wheeler, JW., Shull, PB., Besier, TF.[2011]

A study involving 33 patients after lower limb surgery showed that using a biofeedback device for gait rehabilitation significantly improved adherence to partial weight-bearing instructions compared to traditional verbal cues.

The results indicate that biofeedback can enhance the efficiency of rehabilitation protocols, suggesting it may be a valuable tool in post-surgery recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback versus physiotherapy in patients with partial weight-bearing. Hershko, E., Tauber, C., Carmeli, E.[2022]

A three-week gait retraining program using real-time biofeedback significantly reduced knee hyperextension in 17 young women, with improvements measured immediately after training and sustained at 1-month and 8-month follow-ups.

The study demonstrated that participants retained a reduction in knee hyperextension (from 10.9° to 6.3°) over 8 months, indicating the long-term efficacy of real-time biofeedback for correcting gait patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short and long-term effects of gait retraining using real-time biofeedback to reduce knee hyperextension pattern in young women. Teran-Yengle, P., Cole, KJ., Yack, HJ.[2018]

Gait retraining using the force-driven harmonic oscillator (FDHO) model significantly improved lower-extremity kinematics and kinetics in patients with ACL reconstruction, while the preferred stride frequency (PSF) protocol showed no improvements.

The FDHO protocol led to better recovery in knee range of motion and hip extensor function over a 6-week training period, indicating its effectiveness in enhancing gait patterns post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait retraining after anterior cruciate ligament reconstruction. Decker, MJ., Torry, MR., Noonan, TJ., et al.[2022]

In a study involving 20 individuals with knee osteoarthritis, real-time biofeedback significantly reduced performance error in toe-out gait modification compared to mirror and raw video feedback methods, with a mean difference of 2.05° and 1.51°, respectively.

Despite the improvement in performance error with real-time biofeedback, participants did not perceive a significant difference in difficulty across the feedback methods, suggesting that the benefits of real-time biofeedback may not justify its higher costs in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of mirror, raw video, and real-time visual biofeedback for training toe-out gait in individuals with knee osteoarthritis. Hunt, MA., Takacs, J., Hart, K., et al.[2014]

The biofeedback gait-training system effectively measures and analyzes gait problems, providing real-time visual and audio feedback to help users improve their walking patterns during rehabilitation.

Experiments with both normal subjects and those with degenerative knee joints demonstrated that the system significantly aids in correcting pathological gait, indicating its potential for broad application in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback gait training system for temporal and distance factors. Hirokawa, S., Matsumura, K.[2019]

In a study involving 27 individuals with chronic ankle instability, those who received visual gait biofeedback (GBF) showed a significant reduction in ankle inversion during walking compared to those who did not receive biofeedback (NBF).

The GBF group also reported greater improvements in patient-reported outcomes related to daily activities and sports, indicating that combining visual biofeedback with rehabilitation can enhance recovery in individuals with chronic ankle instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait biofeedback and impairment-based rehabilitation for chronic ankle instability. Koldenhoven, RM., Jaffri, AH., DeJong, AF., et al.[2021]

Biofeedback targeting lower extremity loading mechanics after anterior cruciate ligament reconstruction (ACLR) can significantly alter stride interval dynamics, which may help prevent post-traumatic osteoarthritis.

In a study with 12 participants, both high and low loading conditions led to more temporally persistent stride intervals compared to a control condition, suggesting that feedback can effectively influence gait strategies in individuals recovering from ACLR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback augmenting lower limb loading alters the underlying temporal structure of gait following anterior cruciate ligament reconstruction. Armitano-Lago, C., Pietrosimone, B., Davis-Wilson, HC., et al.[2022]

Rhythmic stimulation, whether through vibrotactile or auditory methods, significantly improves stance time symmetry ratio (STSR) in healthy adults with induced gait asymmetry, suggesting its potential for gait rehabilitation.

Both types of rhythmic stimulation were equally effective in enhancing gait parameters, indicating that either method could be used to aid individuals with mobility impairments in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Short-Term Effects of Rhythmic Vibrotactile and Auditory Biofeedback on the Gait of Individuals After Weight-Induced Asymmetry. Michelini, A., Sivasambu, H., Andrysek, J.[2023]

Real-time biofeedback gait training effectively reduces knee adduction moment (KAM) in patients with knee osteoarthritis (KOA), with improvements in pain and function observed, as indicated by standardized mean differences ranging from 0.29 to 1.16 across studies.

The review highlighted that implicit instructions during biofeedback training led to greater reductions in KAM in healthy controls, suggesting that the method of instruction may influence the effectiveness of gait retraining strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait Retraining With Real-Time Biofeedback to Reduce Knee Adduction Moment: Systematic Review of Effects and Methods Used. Richards, R., van den Noort, JC., Dekker, J., et al.[2022]

A novel biofeedback intervention aimed at improving landing mechanics in 40 patients post-ACL reconstruction showed significant improvements in peak vertical ground reaction force symmetry after 12 sessions over six weeks, but these improvements were not maintained in the long term.

Despite the initial benefits in symmetry, the biofeedback program did not effectively reduce risk factors for subsequent ACL injuries, suggesting the need for further research into more comprehensive intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of risk factors for ACL Re-injuries using an innovative biofeedback approach: A phase I randomized clinical trial. Peebles, AT., Miller, TK., Savla, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10729376/

The effectiveness of a 6-week biofeedback gait retraining ... This study aims to evaluate the acute (6 weeks of training) and chronic (1 month post training) effects of biofeedback based on personalised gait patterns to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05363683

Optimizing Movement After Anterior Cruciate Ligament Injury This study will determine the efficacy of the visual biofeedback program initiated two weeks after ACLR by assessing movement biomechanics and MRI changes in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6667313/

Real-time biofeedback is more effective than sham feedback ... This study demonstrates that the interactive feedback system guided participants to significantly improve movement biomechanics during performance of a body ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999316303471

Gait Retraining With Real-Time Biofeedback to Reduce ... This review suggests that biofeedback gait training is effective primarily for reducing KAM but also for reducing pain and improving function in patients with ...

5. withpower.com withpower.com/trial/phase-osteoarthritis-4-2023-e4f74

Gait Rehabilitation for Knee Osteoarthritis After ACL Injury The purpose of this study is to determine the effects of real-time gait biofeedback delivered over a 6-week period on early markers of FastOA and conduct ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1466853X22000992

Reduction of risk factors for ACL Re-injuries using an ... This phase I clinical trial explored the safety and initial efficacy of using a novel visual and tactile biofeedback intervention to reduce risk factors for ...