ACLMi-SPANCT06529692
Michigan Split-belt Treadmill Training Program to Improve Long-Term Knee Biomechanics After ACL Reconstruction
A study testing Split-Belt Training in people with ACL and Anterior Cruciate Ligament, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- ACL, Anterior Cruciate Ligament, ACL Injury
- What is being tested?
- Split-Belt Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 14-45 years
- suffered an acute, complete ACL rupture as confirmed by MRI and physical exam
- have undergone ACL reconstruction w autograft within the past 10 months
- willingness to participate in testing and follow-up as outlined in the protocol
- English-speaking
Who cannot join
- inability to provide written informed consent
- female subjects who are pregnant or are planning to become pregnant (self-reported)
- previous ACL injury
- previous surgery to either knee
- bony fracture accompanying ACL injury
- patients who experienced a knee dislocation
- patients who had their ACL reconstructed with an allograft
- patients who underwent a multi-ligamentous and/or staged ACL reconstruction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48176
Riann Palmieri-Smith, PhD, 7348343342, riannp@umich.edu
Alexa Johnson, PhD, 734-615-1297, akjohns@med.umich.edu
About this study
Official title: Mi-SPA: Michigan Split-belt Adaptation Paradigm to Improve Knee Loading After Anterior Cruciate Ligament Reconstruction (Aim 3)
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.
Read more
The investigators' main question for this aim is:
- Does knee loading, measured by the sagittal plane knee moment, change to a greater extent in the split-belt treadmill training groups compared to the placebo group?
- Are there differences in training-related knee loading changes between individuals trained in the early stance vs. midstance loading split-belt training?
Read the detailed description
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.
- Conditions
- ACL, Anterior Cruciate Ligament, ACL Injury
- Being tested
- Placebo Split-Belt Training, Split-Belt Training
- Keywords
- Biomechanics, Knee Loading, Split-Belt Treadmill, Asymmetric Walking
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Split-Belt TrainingBehavioural
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.
Split-Belt TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Stance Training | Experimental | 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. Receives: Behavioral: Split-Belt Training |
| Mid-Stance Training | Experimental | 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. Receives: Behavioral: Split-Belt Training |
| Placebo Split-Belt Training | Placebo comparator | 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. Receives: Behavioral: Placebo Split-Belt Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACL Leg Sagittal Plane Knee Moment
Peak Sagittal Plane Knee Moment recorded during walking gait
Measured: Before training, midway through training (3 weeks), & after training (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start13 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACLStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Riann Palmieri-Smith, University of Michigan
- Investigators
- Riann M Palmieri-Smith, PhD, ATC, Principal investigator, University of MichiganChandramouli Krishnan, PT, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529692
- Sponsor's protocol ID
- HUM00221406_Aim3
- Other IDs
- 1R21AR082643
- Acronym
- Mi-SPA
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made publicly available via Deep Blue Data which is managed by the University of Michigan.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mi-SPA: Michigan Split-belt Adaptation Paradigm to Improve Knee Loading After Anterior Cruciate Ligament Reconstruction (Aim 3)
- ClinicalTrials.gov ID
- NCT06529692
- Acronym / sponsor ID
- Mi-SPA / HUM00221406_Aim3
- Conditions
- ACL, Anterior Cruciate Ligament, ACL Injury
- Keywords
- Biomechanics, Knee Loading, Split-Belt Treadmill, Asymmetric Walking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does knee loading, measured by the sagittal plane knee moment, change to a greater extent in the split-belt treadmill training groups compared to the placebo group?
- Are there differences in training-related knee loading changes between individuals trained in the early stance vs. midstance loading split-belt training?
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Stance Training | Experimental | Behavioral: Split-Belt TrainingThis 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. |
| Mid-Stance Training | Experimental | Behavioral: Split-Belt TrainingThis 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. |
| Placebo Split-Belt Training | Placebo comparator | Behavioral: Placebo Split-Belt TrainingThis 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. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- aged 14-45 years
- suffered an acute, complete ACL rupture as confirmed by MRI and physical exam
- have undergone ACL reconstruction w autograft within the past 10 months
- willingness to participate in testing and follow-up as outlined in the protocol
- English-speaking
Key exclusion criteria (8 listed)
- inability to provide written informed consent
- female subjects who are pregnant or are planning to become pregnant (self-reported)
- previous ACL injury
- previous surgery to either knee
- bony fracture accompanying ACL injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Split-Belt TrainingWalking 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. | Behavioural | Placebo Split-Belt Training |
| Split-Belt TrainingWalking 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. | Behavioural | Early Stance Training, Mid-Stance Training |
Primary outcome
ACL Leg Sagittal Plane Knee Moment
Time frame: Before training, midway through training (3 weeks), & after training (6 weeks)
Peak Sagittal Plane Knee Moment recorded during walking gait
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be made publicly available via Deep Blue Data which is managed by the University of Michigan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Riann M Palmieri-Smith, PhD, ATC principal investigator
University of Michigan
Chandramouli Krishnan, PT, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-Belt Training in people with ACL and Anterior Cruciate Ligament, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexa Johnson, PhD (734-615-1297, akjohns@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACL Leg Sagittal Plane Knee Moment (time frame: Before training, midway through training (3 weeks), & after training (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.