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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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.
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Who is running the clinical trial?
Arthritis FoundationOTHER
34 Previous Clinical Trials
46,081 Total Patients Enrolled
11 Trials studying Osteoarthritis
2,708 Patients Enrolled for Osteoarthritis
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,972 Total Patients Enrolled
24 Trials studying Osteoarthritis
1,855 Patients Enrolled for Osteoarthritis
Brian Pietrosimone, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
157 Total Patients Enrolled
2 Trials studying Osteoarthritis
97 Patients Enrolled for Osteoarthritis
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is the ideal target audience for this medical experiment?
"This clinical trial seeks to onboard 70 individuals between the ages of 16 and 35 who have sustained knee traumas as participants."
Answered by AI
Is the age requirement for participants of this experiment greater than 30 years?
"Individuals between 16 and 35 years of age are eligible for this medical trial. In comparison, there are 204 clinical trials targeting paediatric patients and 1,332 that focus on seniors over 65."
Answered by AI
Is recruitment into this trial still open to the public?
"According to the information available at clinicaltrials.gov, this medical trial is no longer actively recruiting participants; with its last update occuring on April 28th 2023. Despite that however, there are 1,579 other studies currently seeking patients."
Answered by AI
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