Treatment for Gait

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of North Carolina at Chapel Hill, Chapel Hill, NC
Gait+8 More
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether real-time gait biofeedback can improve gait biomechanics and reduce the risk of early post-traumatic osteoarthritis in people with an anterior cruciate ligament reconstruction.

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Eligible Conditions

  • Gait
  • Posttraumatic Osteoarthritis
  • Knee Injuries
  • Anterior Cruciate Ligament Tear
  • Osteoarthritis of the Knee
  • Cartilage, Articular

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 6 primary outcomes and 17 secondary outcomes in patients with Gait. Measurement will happen over the course of Baseline (pre-intervention).

About 2 months
Number of subjects who adhered to the intervention
Week 8
Percentage of participants retained
Baseline (pre-intervention)
Number of participants recruited using different recruitment modes
Percentage of participants who were successfully enrolled
Reasons for refusal to enroll
The frequency of participant recruitment using different recruitment modes
Up to 2 months
The change in T1ρ MRI relaxation times before and after intervention
The change in T1ρ MRI relaxation times in the lateral femoral condyle before and after intervention
The change in T1ρ MRI relaxation times in the lateral tibial condyle before and after intervention
The change in T1ρ MRI relaxation times in the medial femoral condyle before and after intervention
The change in T1ρ MRI relaxation times in the medial tibial condyle before and after intervention
The change in joint tissues metabolism by assessing biomarker chemokine (monocyte chemoattractant protein-1 (MCP-1)).
The change in joint tissues metabolism by assessing degenerative matrix metalloproteinase-3 (MMP-3) enzyme.
The change in joint tissues metabolism by assessing marker of cartilage turnover (cartilage oligomeric matrix protein (COMP)).
The change in peak internal knee extension moment
The change in peak knee flexion excursion
The change in peak vGRF
The change in the Anterior Cruciate Ligament Return to Sport After Injury Scale score
The change in the International Knee Documentation Committee Subjective Knee Evaluation form score
The change in the Knee Injury and Osteoarthritis Outcome Quality of Life subscale score
The change in the Tegner Activity Scale score
The change in the Visual, Aural, Reading/Writing, and Kinesthetic Questionnaire score
The change in vertical ground reaction force before and after intervention

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Real-time gait biofeedback (RTGBF)
1 of 2
Sham real-time gait biofeedback (Sham RTGBF)
1 of 2
Active Control
Non-Treatment Group

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Real-time gait biofeedback (RTGBF)
Behavioral
The RTGBF regimen delivers biofeedback that cues a personalized target to normalize vertical ground reaction force (vGRF) of each limb.
Sham real-time gait biofeedback (Sham RTGBF)
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 months for reporting.

Closest Location

University of North Carolina at Chapel Hill - Chapel Hill, NC

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have knee symptoms that affect your quality of life and they are clinically relevant. show original
Demonstrate a reduced impact peak when you walk (< 1.09 times your body weight). show original
I have completed all of my physical therapy exercises. show original
Are between the ages of 18 and 35 years old. show original
Had an ACL reconstruction between 6 and 24 months prior to enrolling in the study. show original
I have had surgery to fix my ACL. show original

Patient Q&A Section

Can anterior cruciate ligament tear be cured?

"Anterior cruciate ligament tears healed in the majority of patients. Postoperative MRI scans revealed no change in the healing process after the injury, which can be attributed to a tight, stable hamstring tendon attachment." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anterior cruciate ligament tear?

"Treatment for Anterior Cruciate Ligament Tear varies considerably between clinicians and is heavily influenced by cost and the availability of facilities and treatment team members that can provide it. While no surgery was found to outperform conservative and non-operative treatment, knee arthroplasty is a viable option for patients with non-stable, moderate knee injuries. The best outcome after ACLT is achieved with surgical reconstruction and grafting, but the majority of patients can expect a functional knee with good quality of life." - Anonymous Online Contributor

Unverified Answer

How many people get anterior cruciate ligament tear a year in the United States?

"Anterior cruciate ligament injury causes the biggest number of ACL tears in young athletes but these statistics reflect only those of high school athletes. The majority of ACL tears and injuries occur in high school-age athletes aged 15 to 29 years." - Anonymous Online Contributor

Unverified Answer

What is anterior cruciate ligament tear?

"ACL tear can occur at the time of a minor injury, and is more common in males. This injury rarely results in reconstruction or reconstruction in conjunction with an ACL reconstruction." - Anonymous Online Contributor

Unverified Answer

What causes anterior cruciate ligament tear?

"Findings from a recent study showed there was a difference in subjective and radiographic characteristics between athletes with ACL tears and those who did not. This difference is not large and may not be clinically relevant for the determination of injury. However, these results lend support to the idea of the ACL as a multi-tendinous knee structure rather than a single "lateral" structure." - Anonymous Online Contributor

Unverified Answer

What are the signs of anterior cruciate ligament tear?

"The physical and MR imaging findings in people with an ACL tear are varied, and the clinical signs, which are nonspecific and vary greatly, are nonspecific also. While pain and weakness are common, signs of instability and signs of ligament damage are less common." - Anonymous Online Contributor

Unverified Answer

Does anterior cruciate ligament tear run in families?

"There is evidence that families may be more prone to having athletes develop anterior cruciate ligament injury if an injury was experienced in a close relative of the same sex." - Anonymous Online Contributor

Unverified Answer

How serious can anterior cruciate ligament tear be?

"If we take into perspective the fact that an athlete may be more likely to have an ACL tear than they are to be injured by a car, then maybe the injury to the anterior cruciate ligament is the least serious ACL injury. Because most ACL tears heal in about three months and most patients return their previous level of sports in a few months, the ACL tear is not as critical a danger to the knees as the posterior cruciate ligament tear." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets anterior cruciate ligament tear?

"Data from a recent study does not provide any evidence for an association between ACL injury and sex or ethnicity when considering gender and ethnic group as independent factors. Data from a recent study, however, showed that the average age for ACL injury was 32 years. This suggests that sports and physical activity are more of a problem for girls than for boys." - Anonymous Online Contributor

Unverified Answer

Has treatment proven to be more effective than a placebo?

"There is not enough clinical evidence to show that treatment is more effective than placebo in ACL-injured patients. Further research is required to identify the best treatment for ACL-injured patients in a precise and robust fashion, and only when a cure for ACL injuries is achievable, then treatment effects will be more apparent. Until then, it is important to use current knowledge and data, in conjunction with the patient preferences and the cost of a specific treatment, to reach a good decision." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for anterior cruciate ligament tear?

"Patients with symptomatic ACL and non-surgical history should be considered for a trial of the experimental ACL reconstruction procedures. Patients who continue to have instability after surgical treatment may be best for autograft or allograft placement." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"Since 2011, there is an increasing number of orthopedic surgeons who use arthroscopic techniques for the treatment of traumatic injuries of the shoulder and knee. This is because of the excellent short-term outcomes, the low costs, and because there is no open surgical surgery for shoulder and knee injuries at this time." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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