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Gait Rehabilitation for Knee Osteoarthritis After ACL Injury

N/A

Recruiting

Led By Brian Pietrosimone, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Summary

This trial will study how feedback on walking can help ACL-reconstructed patients improve their knee stability over 6 weeks with follow-up assessments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive interventions like gait training with biofeedback rather than medication or surgery, side effects are minimal but may include muscle fatigue or psychological discomfort from awareness of walking patterns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Biomarker Chemokine (Monocyte Chemoattractant Protein-1 (MCP-1)).

Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-1 (MMP-1) Enzyme

Mean Change from Baseline to Month 6 in Joint Tissues Metabolism by Assessing Degenerative Matrix Metalloproteinase-3 (MMP-3) Enzyme

+23 more

Secondary study objectives

Change in the Anterior Cruciate Ligament Return to Sport After Injury Scale Score

Change in the International Knee Documentation Committee Subjective Knee Evaluation Form Score

Change in the Tegner Activity Scale Score

Trial Design

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.

Do I qualify?Apply below to find out