Actively Recruiting
Michigan Split-belt Treadmill Training to Improve Knee Loading After ACL Reconstruction A Pilot Randomized Clinical Trial Evaluating Early and Midstance Training
Led by University of Michigan · Updated on 2025-09-08
9
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a 6-week split-belt treadmill training program to improve knee loading after anterior cruciate ligament (ACL) reconstruction. The study aims to understand whether knee loading, measured by the sagittal plane knee moment, changes more in subjects undergoing split-belt training compared to a placebo group. It also compares knee loading adaptations between early stance and midstance split-belt training methods. This pilot randomized clinical trial will collect data from 9 participants to inform future larger studies. Participants will be randomly assigned to one of three groups: early stance split-belt training, mid-stance split-belt training, or placebo split-belt training. Each training program involves walking on a split-belt treadmill twice a week for 20 minutes over six weeks. In the early stance group, the ACL leg walks at 150-170% of 1.1 m/s, while the non-ACL leg walks at 1.1 m/s. The mid-stance group walks with the ACL leg at 30-50% of 1.1 m/s, and the placebo group walks with the ACL leg at a speed 10% different from 1.1 m/s, with the non-ACL leg walking at 1.1 m/s in all groups. Participants will be assessed at the start, mid-point (3 weeks), and end (6 weeks) of training. The main measurement is the sagittal plane knee moment on the ACL leg. Additional evaluations include vertical ground reaction force, knee joint contact force, and the Knee Injury and Osteoarthritis Outcome Score. Knee cartilage thickness in medial and lateral compartments will be measured before and after training. The study includes follow-up assessments and monitoring to understand training effects over the six-week period.
CONDITIONS
Brief Title
Michigan Split-belt Treadmill Training Program to Improve Long-Term Knee Biomechanics After ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 14 to 45 years
- Acute, complete ACL rupture confirmed by MRI and physical exam
- Underwent ACL reconstruction with autograft within past 10 months
- Willingness to participate in testing and follow-up as outlined
- English-speaking
You will not qualify if you...
- Unable to provide written informed consent
- Female subjects who are pregnant or planning to become pregnant (self-reported)
- Previous ACL injury
- Previous surgery to either knee
- Bony fracture accompanying ACL injury
- History of knee dislocation
- ACL reconstructed with allograft
- Multi-ligamentous and/or staged ACL reconstruction
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 - 6 weeks
Participants complete a 6-week split-belt treadmill training program, walking twice a week for 20 minutes per session. The training involves walking on a split-belt treadmill with different speed settings for the ACL leg depending on the group assignment (early stance, mid-stance, or placebo training).
Twice weekly visits for up to 6 weeks
Duration - 6 weeks
Participants are assessed before, midway (3 weeks), and after the 6-week training to evaluate knee biomechanics and related outcomes.
3 assessment visits during treatment period
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48176
Actively Recruiting
Research Team
A
Alexa Johnson, PhD
R
Riann M Palmieri-Smith, PhD, ATC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here