Gait Rehabilitation for Knee Osteoarthritis After ACL Injury

Recruiting in Palo Alto (17 mi)

Overseen by Brian G Pietrosimone, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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-week and 6-month follow-up assessments in anterior cruciate ligament reconstructed 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 data supports the effectiveness of the treatment Real-time gait biofeedback for knee osteoarthritis after ACL injury?

Research shows that biofeedback, which provides real-time sensory feedback, can improve gait rehabilitation outcomes by helping people adjust their walking patterns. This approach has been effective in improving gait mechanics after ACL reconstruction, which may suggest potential benefits for knee osteoarthritis rehabilitation as well. ^{1 2 3 4 5}

Is real-time gait biofeedback safe for humans?

Research on real-time gait biofeedback, used for various conditions like knee hyperextension and chronic ankle instability, shows it is generally safe for humans. Studies have not reported any significant safety concerns, indicating it can be a safe method for gait retraining. ^{1 6 7 8 9}

How does real-time gait biofeedback treatment differ from other treatments for knee osteoarthritis after ACL injury?

Real-time gait biofeedback is unique because it provides immediate feedback to patients on their walking patterns, helping them adjust their gait in real-time to reduce stress on the knee joint. This approach is noninvasive and uses visual or tactile cues to guide patients in modifying their movements, which can be more effective and efficient than traditional methods that rely on verbal instructions alone. ^{2 7 9 10 11}

Research Team

Brian G Pietrosimone, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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 finished all my prescribed physical therapy sessions.

I am between 16 and 35 years old.

Exclusion Criteria

My BMI is 36 or higher.

I have knee osteoarthritis.

I am scheduled for or have had ACL revision surgery.

Trial Timeline

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

Treatment Details

Interventions

• Real-time gait biofeedback (Behavioural Intervention)
• Sham real-time gait biofeedback (Behavioural Intervention)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of North Carolina at Chapel Hill Chapel Hill, NC

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1588

Patients Recruited

4,364,000+

Arthritis Foundation

Collaborator

Trials

36

Patients Recruited

46,500+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

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

Reduction of risk factors for ACL Re-injuries using an innovative biofeedback approach: A phase I randomized clinical trial. [2023]

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

Gait retraining after anterior cruciate ligament reconstruction. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Biofeedback augmenting lower limb loading alters the underlying temporal structure of gait following anterior cruciate ligament reconstruction. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

The Short-Term Effects of Rhythmic Vibrotactile and Auditory Biofeedback on the Gait of Individuals After Weight-Induced Asymmetry. [2023]

5. United States 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. [2014]

6. England 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. [2018]

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

Biofeedback gait training system for temporal and distance factors. [2019]

8. Denmark pubmed.ncbi.nlm.nih.gov

Gait biofeedback and impairment-based rehabilitation for chronic ankle instability. [2021]

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

Gait Retraining With Real-Time Biofeedback to Reduce Knee Adduction Moment: Systematic Review of Effects and Methods Used. [2022]

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

Real-time knee adduction moment feedback for gait retraining through visual and tactile displays. [2011]

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

Biofeedback versus physiotherapy in patients with partial weight-bearing. [2022]