← Back to Search

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 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.

Find a Location

Who is running the clinical trial?

Arthritis FoundationOTHER
35 Previous Clinical Trials
46,411 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,514 Total Patients Enrolled
2 Trials studying Anterior Cruciate Ligament Injury
177 Patients Enrolled for Anterior Cruciate Ligament Injury
Brian Pietrosimone, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
157 Total Patients Enrolled

Media Library

Real-time gait biofeedback Clinical Trial Eligibility Overview. Trial Name: NCT05848622 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: Real-time gait biofeedback (RTGBF), Sham real-time gait biofeedback (Sham RTGBF)
Anterior Cruciate Ligament Injury Clinical Trial 2023: Real-time gait biofeedback Highlights & Side Effects. Trial Name: NCT05848622 — N/A
Real-time gait biofeedback 2023 Treatment Timeline for Medical Study. Trial Name: NCT05848622 — N/A
~13 spots leftby May 2025