Gait Rehabilitation for Knee Osteoarthritis After ACL Injury
Recruiting in Palo Alto (17 mi)
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.12345
Is real-time gait biofeedback safe for humans?
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.2791011
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.
See 2 more
Exclusion Criteria
My BMI is 36 or higher.
I have knee osteoarthritis.
I am scheduled for or have had ACL revision surgery.
See 2 more
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 OverviewThe 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
2Treatment groups
Active Control
Placebo Group
Group I: Real-time gait biofeedback (RTGBF)Active Control1 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 Group1 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 NearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
Arthritis FoundationCollaborator
References
Reduction of risk factors for ACL Re-injuries using an innovative biofeedback approach: A phase I randomized clinical trial. [2023]Determine the safety and initial efficacy of a novel biofeedback intervention to improve landing mechanics in patients following anterior cruciate ligament reconstruction (ACLR).
Gait retraining after anterior cruciate ligament reconstruction. [2022]To examine the effects of 2 gait retraining protocols on the gait patterns of patients with bone-patellar tendon-bone anterior cruciate ligament (ACL) reconstruction.
Biofeedback augmenting lower limb loading alters the underlying temporal structure of gait following anterior cruciate ligament reconstruction. [2022]Biofeedback has recently been explored to target deviant lower extremity loading mechanics following anterior cruciate ligament reconstruction (ACLR) to mitigate the development of post traumatic osteoarthritis. The impact this feedback has on the structure of the stride interval dynamics-a barometer of gait system health-however, have yet to be examined. This study was designed to assess how feedback, used to alter lower-extremity loading during gait, affects the structure of stride interval variability by examining long-range stride-to-stride correlations during gait in those with unilateral ACLR. Twelve participants walked under three separate loading conditions: (1) control (i.e., no cue) (2) high loading, and (3) low loading. Baseline vertical ground reaction force (vGRF) data was used to calculate a target 5% change in vGRF for the appropriate loading condition (i.e., high loading was +5% vGRF, low loading was -5% vGRF). The target for the load condition was displayed on a screen along with real-time vGRF values, prescribing changes in stride-to-stride peak vertical ground reaction forces of each limb. From time-series of stride intervals (i.e., duration), we analyzed the mean and standard deviation of stride-to-stride variability and, via detrended fluctuation analysis (i.e., DFA α), temporal persistence for each feedback condition. Both the high and low loading conditions exhibited a change toward more temporally persistent stride intervals (high loading: α =0.92, low loading: α = 0.98) than walking under the control condition (α = 0.78; high vs. control: p = .026, low vs. control: p = .001). Overall, these results indicate that altering lower extremity load changes the temporal persistence of the stride internal dynamics in ACLR individuals, demonstrating the implications of the design of gait training interventions and the influence feedback has on movement strategies.
The Short-Term Effects of Rhythmic Vibrotactile and Auditory Biofeedback on the Gait of Individuals After Weight-Induced Asymmetry. [2023]Biofeedback (BFB), the practice of providing real-time sensory feedback has been shown to improve gait rehabilitation outcomes. BFB training through rhythmic stimulation has the potential to improve spatiotemporal gait asymmetries while minimizing cognitive load by encouraging a synchronization between the user's gait cycle and an external rhythm.
Comparison of mirror, raw video, and real-time visual biofeedback for training toe-out gait in individuals with knee osteoarthritis. [2014]To compare performance error and perceived difficulty during toe-out gait modification in people with knee osteoarthritis (OA) across 3 different types of visual feedback: mirror, raw video, and real-time biofeedback of toe-out angle.
Short and long-term effects of gait retraining using real-time biofeedback to reduce knee hyperextension pattern in young women. [2018]The use of real-time biofeedback has been shown to enable individuals to make changes to their gait patterns. It remains unknown whether the short-term improvements reported in previous studies are retained in the longer term. In this study, the paradigm used to investigate the short and long-term effects of real-time biofeedback was modifying knee range of motion during gait to prevent knee hyperextension in women. The purpose of this study was to investigate the short-term (1-month follow up) and long-term (8-month follow up) effects of a gait retraining program using real-time biofeedback to correct knee hyperextension in young women. Seventeen healthy women, ages 18-35 years, with asymptomatic knee hyperextension underwent a three-week (6 sessions) treadmill gait retraining program. Real-time feedback of kinematic data (Visual 3D) was provided during treadmill training. Knee extension range of motion was monitored during overground gait evaluations and training sessions. Gait evaluations were performed pretraining, posttraining (2days after), and 1-month, and 8-month after the last training session. This study showed significant reduction in knee hyperextension patterns immediately following training (mean±SD, 10.9°±4°), and at 1-month (7.5°±5°) and 8-month (6.3°±3.5°) follow ups. There was an increase in knee extension between posttraining and 1-month follow up (3.4°±5°). Reduction in knee hyperextension range of motion was retained at 8-month follow up evaluation. The present study shows the effects of real-time biofeedback in facilitating the acquisition and retention of proficiency in reducing knee hyperextension gait patterns, documenting that the retention is sustained for up to 8 months.
Biofeedback gait training system for temporal and distance factors. [2019]A biofeedback gait-training system has been developed which can deal with the gait problems of all subjects in any phase of rehabilitation: measurement, analysis, training and/or evaluation. The system is composed of a measuring walkway and a training walker. The walkway can measure all the temporal and distance factors of gait. The walker, with two parallel grasping bars and a CRT monitor, moves automatically with the aid of servo-motors. The system provides visual feedback for distance factors of gait and audio feedback for temporal factors. During the single-support phase the desired foot position for the next step and the supporting foot position are displayed on the CRT. The actual position of the foot placement is then overlaid for the double support duration that follows. A trainee learns to place the foot in such a way as to overlap the desired with the actual foot stamps on the CRT. The desired temporal factors are provided by buzzer tones. A trainee tries to shorten or elongate the duration of the respective phase of the gait cycle in accordance with the tone. Some experiments on normal subjects and on some with degenerative knee joints verified that the biofeedback signals were utilised effectively and that the walker was of value for improving pathological gait.
Gait biofeedback and impairment-based rehabilitation for chronic ankle instability. [2021]Our purpose was to analyze the effects of 4 weeks of visual gait biofeedback (GBF) and impairment-based rehabilitation on gait biomechanics and patient-reported outcomes (PROs) in individuals with chronic ankle instability (CAI). Twenty-seven individuals with CAI participated in this randomized controlled trial (14 received no biofeedback (NBF), 13 received GBF). Both groups received 8 sessions of impairment-based rehabilitation. The GBF group received visual biofeedback to reduce ankle frontal plane angle at initial contact (IC) during treadmill walking. The NBF group walked for equal time during rehabilitation but without biofeedback. Dependent variables included three-dimensional kinematics and kinetics at the ankle, knee, and hip, electromyography amplitudes of 4 lower extremity muscles (tibialis anterior, fibularis longus, medial gastrocnemius, and gluteus medius), and PROs (Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL), FAAM-Sport, Tampa Scale of Kinesiophobia (TSK), and Global Rating of Change (GROC)). The GBF group significantly decreased ankle inversion at IC (MD:-7.3º, g = 1.6) and throughout the entire stride cycle (peak inversion: MD:-5.9º, g = 1.2). The NBF group did not have significantly altered gait biomechanics. The groups were significantly different after rehabilitation for the FAAM-ADL (GBF: 97.1 ± 2.3%, NBF: 92.0 ± 5.7%), TSK (GBF: 29.7 ± 3.7, NBF: 34.9 ± 5.8), and GROC (GBF: 5.5 ± 1.0, NBF:3.9 ± 2.0) with the GBF group showing greater improvements than the NBF group. There were no significant differences between groups for kinetics or electromyography measures. The GBF group successfully decreased ankle inversion angle and had greater improvements in PROs after intervention compared to the NBF group. Impairment-based rehabilitation combined with visual biofeedback during gait training is recommended for individuals with CAI.
Gait Retraining With Real-Time Biofeedback to Reduce Knee Adduction Moment: Systematic Review of Effects and Methods Used. [2022]To review the current literature regarding methods and effects of real-time biofeedback used as a method for gait retraining to reduce knee adduction moment (KAM), with intended application for patients with knee osteoarthritis (KOA).
Real-time knee adduction moment feedback for gait retraining through visual and tactile displays. [2011]The external knee adduction moment (KAM) measured during gait is an indicator of tibiofemoral joint osteoarthritis progression and various strategies have been proposed to lower it. Gait retraining has been shown to be an effective, noninvasive approach for lowering the KAM. We present a new gait retraining approach in which the KAM is fed back to subjects in real-time during ambulation. A study was conducted in which 16 healthy subjects learned to alter gait patterns to lower the KAM through visual or tactile (vibration) feedback. Participants converged on a comfortable gait in just a few minutes by using the feedback to iterate on various kinematic modifications. All subjects adopted altered gait patterns with lower KAM compared with normal ambulation (average reduction of 20.7%). Tactile and visual feedbacks were equally effective for real-time training, although subjects using tactile feedback took longer to converge on an acceptable gait. This study shows that real-time feedback of the KAM can greatly increase the effectiveness and efficiency of subject-specific gait retraining compared with conventional methods.
Biofeedback versus physiotherapy in patients with partial weight-bearing. [2022]Medical instructions for partial weight-bearing after lower limb surgery and fractures are commonly given. The techniques for instruction are mainly verbal cues. Our aim was to evaluate the efficiency of a new biofeedback device compared with traditional intervention for gait rehabilitation. After orthopedic surgery, 33 patients, randomly divided into a study group (n = 15) and a control group (n = 18), completed 10 days of a rehabilitation protocol. A significant difference (P