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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
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 moreSecondary 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had ACL surgery between 6 months and 5 years ago.My BMI is 36 or higher.I have knee osteoarthritis.I am scheduled for or have had ACL revision surgery.I have finished all my prescribed physical therapy sessions.I am between 16 and 35 years old.I have had surgery on multiple ligaments.I have a broken bone in my leg.I have significant knee pain or problems.My walking force is less than 1.12 times my body weight.
Research Study Groups:
This trial has the following groups:- Group 1: Real-time gait biofeedback (RTGBF)
- Group 2: Sham real-time gait biofeedback (Sham RTGBF)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.