An interventional study of Placebo Split-Belt Training and Split-Belt Training in ACL, Anterior Cruciate Ligament and ACL Injury, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 14 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
Among 11 studies in Anterior Cruciate Ligament Injuries by University of Michigan — 1 open to participants now, 1 under way, none of them phase 3. Anterior Cruciate Ligament Injuries · University of Michigan.
Among the 11 studies in Anterior Cruciate Ligament Injuries by University of Michigan, this one is the 10th largest by planned enrollment of the 10 interventional ones, is the only one that started in 2025, is one of 9 with no phase, and was the 10th registered.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's planned enrollment of 9 is below the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →1 of the 11 studies in Anterior Cruciate Ligament Injuries by University of Michigan is open now, in 1 country. Each count lists the studies.
Of the 121 Anterior Cruciate Ligament Injuries studies recruiting now, 27 (22%) set no upper age limit and 91 (75%) stop at 75 or younger; 46 take children under 18; 21 take healthy volunteers.
This study: 14 Years to 45 Years · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2025.
Median enrollment 31 across the 10 interventional studies, 13 across the 1 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
1 of the studies in Anterior Cruciate Ligament Injuries by University of Michigan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06529692University of MichiganMichigan Split-belt Treadmill Training Program to Improve Long-Term Knee Biomechanics After ACL Reconstruction | 2026-12 |
Among the 11 studies in Anterior Cruciate Ligament Injuries by University of Michigan, from their registry updates:
Nothing recorded among them since 2026-09-25.
The goal of this study is to gather pilot data to help inform a future clinical trial. As such, the investigators will employ a randomized clinical trial design, but data will only be collected on 9 total subjects. Nine subjects will be randomized to 2 split-belt intervention groups (one group where early stance loading is trained and the other where midstance loading is trained) and a placebo group.
The goal of this study is to explore the adaptations in knee loading from a 6-week split-belt training intervention.
The investigators' main question for this aim is:
It is commonplace for individuals after anterior cruciate ligament (ACL) reconstruction to shift mechanical demands away from their surgical knee and limb. This manifests as diminished knee moments and vertical ground reaction forces in the ACL limb during everyday tasks (e.g., walking, running, standing, landing, etc.) and persists for as long as 2.5 years after surgery. This pattern of underloading is considered maladaptive, as it has been linked to re-injury and biological markers that are consistent with the development of post-traumatic osteoarthritis that affects over 50% of knees 10-20 years after surgical reconstruction.
Split-belt treadmill training is a gait retraining approach where treadmill belt speeds are decoupled (i.e., one belt is set to move at a faster or slower speed than the other belt) during walking. Split-belt training is based on well-established motor learning principles, such as error-based learning and variability of practice which can lead to locomotor adaptations. In healthy individuals, split-belt treadmill walking significantly increases (from baseline) knee moment impulses in the limb on the slow belt than on the fast belt during the braking and propulsive phases of gait. Split-belt treadmill training has also shown promise in individuals with neurological deficits, resulting in significant improvements in gait biomechanics after training.
To explore the adaptations in loading from a 6-week split-belt training intervention, the investigators will conduct a pilot randomized clinical trial design, but data will only be collected on 9 total subjects. Nine subjects will be randomized to one of 3 groups: 1) early stance split-belt treadmill training, 2) mid-stance split-belt treadmill training, or 3) placebo split-belt treadmill training. The primary outcome, sagittal plane knee moment, will be examined before, midway, \& after the 6-weeks of training. Other outcomes, vertical ground reaction force, knee joint contact force, and the Knee Injury and Osteoarthritis Outcome Score, will be measured at the same timepoints. Medial and lateral knee cartilage thickness are additional outcomes that will only be assessed before and after training.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study arm will complete 6-weeks of a split-belt treadmill training program. The program will require participants to walk on a split-belt treadmill 2 times a week for 20 minutes with the ACL leg walking at 150-170% of 1.1 m/s and the Non-ACL leg walking at 1.1 m/s.
Behavioral: Split-Belt Training
This study arm will complete 6-weeks of a split-belt treadmill training program. The program will require participants to walk on a split-belt treadmill 2 times a week for 20 minutes with the ACL leg walking at 30-50% of 1.1 m/s and the Non-ACL leg walking at 1.1 m/s.
Behavioral: Split-Belt Training
This study arm will complete 6-weeks of a split-belt treadmill training program. The program will require participants to walk on a split-belt treadmill 2 times a week for 20 minutes with the ACL leg walking at a speed that is 10% different from 1.1 m/s and the Non-ACL leg walking at 1.1 m/s.
Behavioral: Placebo Split-Belt Training
Walking on a split-belt treadmill in which the belt under the ACL leg will move at a speed that is minimally slower than the other belt.
Walking on a split-belt treadmill in which the treadmill belt under the ACL leg will move at a speed faster or slower than the belt under the Non-ACL leg.
ACL Leg Sagittal Plane Knee Moment
Peak Sagittal Plane Knee Moment recorded during walking gait
Time frame: Before training, midway through training (3 weeks), & after training (6 weeks)
Non-ACL Leg Sagittal Plane Knee Moment
Peak Sagittal Plane Knee Moment recorded from the Non-ACL leg during walking gait
Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)
ACL Leg Vertical Ground Reaction Force
Peak Vertical Ground Reaction Force recorded from the ACL leg during walking gait
Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)
Non-ACL Leg Vertical Ground Reaction Force
Peak Vertical Ground Reaction Force recorded from the Non-ACL leg during walking gait
Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)
ACL Leg Internal Knee Joint Contact Force
Internal knee joint reaction force for the ACL limb estimated using musculoskeletal modeling
Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)
Non-ACL Leg Internal Knee Joint Contact Force
Internal knee joint reaction force for the Non-ACL limb estimated using musculoskeletal modeling
Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS score is a percentage from 0-100, with 0 representing extreme knee problems and 100 representing no knee problems. A higher score indicates fewer knee issues, while a lower score indicates more.
Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)
Medial Cartilage Thickness
Thickness of the cartilage from the medial femoral trochlea measured using ultrasound
Time frame: Before (0 weeks) & after training (6 weeks)
Lateral Cartilage Thickness
Thickness of the cartilage from the lateral femoral trochlea measured using ultrasound
Time frame: Before (0 weeks) & after training (6 weeks)
Plan to share: Yes — De-identified data will be made publicly available via Deep Blue Data which is managed by the University of Michigan.
Supporting information: Study protocol, Informed consent form
Time frame: We will strive to release data to the repository as rapidly as it is possible to analyze experiments and publish results. Data used in publications will be released at the time of publication.
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.
Of 277 non-industry interventional studies with no phase under Anterior Cruciate Ligament Injuries, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 70. This study's planned 16 months is below that.
Counting every sponsor, half of 286 studies reached it within 30 months; a quarter within 14 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
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Anterior Cruciate Ligament Injuries →