Actively Recruiting
Gait Rehabilitation to Treat FastOA
Led by University of North Carolina, Chapel Hill · Updated on 2026-05-28
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
A
Arthritis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of real-time gait biofeedback over a 6-week period on early markers of fast-progressing osteoarthritis (FastOA) in patients who have had anterior cruciate ligament reconstruction. The study includes follow-up assessments at 6 weeks and 6 months to better understand the impact of this intervention on knee health after injury. Participants will receive either a real-time gait biofeedback (RTGBF) regimen or a sham RTGBF regimen. Both groups will undergo eighteen step gait training sessions, gradually increasing to 3,000 steps by the fifth session with full feedback. After the tenth session, feedback will be tapered off gradually. The active RTGBF group receives personalized cues to normalize vertical ground reaction force (vGRF) during walking, while the sham group receives feedback based on their habitual step length. During the study, participants will be monitored for changes in vertical ground reaction force, knee joint contact forces, tibial cartilage strain, and various biomarkers related to joint tissue metabolism and inflammation. Assessments will be conducted at baseline, week 6, and month 6. Patient-reported outcomes including knee injury and osteoarthritis quality of life and activity scales will also be collected. The total study duration includes initial training and follow-up assessments for half a year, with safety and monitoring overseen throughout the trial.
CONDITIONS
Brief Title
Gait Rehabilitation to Treat FastOA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have completed all other formal physical therapy
- Are between the ages of 16 and 35
- Underwent an anterior cruciate ligament reconstruction (ACLR) between 6 and 60 months prior to enrollment
- Demonstrate underloading during gait (vertical ground reaction force impact peak less than 1.12 times body weight)
You will not qualify if you...
- Have had multiple ligament surgery (e.g., posterior cruciate ligament)
- Have had a lower extremity fracture (e.g., displaced tibial plateau fracture)
- Have knee osteoarthritis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 18 step gait training sessions
Participants receive gait rehabilitation through eighteen step gait training sessions. The intervention gradually increases to 3,000 steps by the 5th session with full biofeedback, which is then gradually tapered starting with the 11th session.
18 outpatient visits for step gait training
Duration - Up to 6 months
Participants are monitored for changes in gait mechanics and joint health up to 6 months after treatment.
Visits at Week 6 and Month 6 for assessments
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
Research Team
N
Natalia Favoreto, MS
B
Brian Pietrosimone, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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