ACLMi-SPANCT06529679
Michigan Split-belt Treadmill Training Program to Improve Acute Knee Biomechanics After ACL Reconstruction
A study testing Split-belt Training and Tied-Belt Training in people with ACL and ACL Injury, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this study is to determine short-term adaptations (aftereffects) in knee loading after a 20-minute split-belt treadmill training session in patients with ACL reconstruction. Our main question for this aim are: 1. Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- ACL, ACL Injury
- What is being tested?
- Split-belt Training and Tied-Belt Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2024to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
About this study
Official title: Mi-SPA: Michigan Split-belt Adaptation Paradigm to Improve Knee Loading After Anterior Cruciate Ligament Reconstruction (Aim 2)
The goal of this study is to determine short-term adaptations (aftereffects) in knee loading after a 20-minute split-belt treadmill training session in patients with ACL reconstruction.
Our main question for this aim are:
- Are training-mediated aftereffects in the knee joint moment greater for tied-belt walking or split-belt walking?
- Are training-mediated aftereffects in the knee joint moment different between subjects who train early stance knee loading versus subjects who train mid-stance knee loading?
Read the detailed description
Knee and limb underloading are ubiquitous after anterior cruciate ligament (ACL) reconstruction and fails to resolve with the standard of care rehabilitation. This underloading behavior is clinically concerning and considered maladaptive, as it affects patient function, has been linked to risk for re-injury, and appears to be a precursor for post-traumatic knee osteoarthritis that affects upwards of 50% of patients who undergo an ACL 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 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.
The aim of this project is to determine short-term adaptations (aftereffects) in knee loading after a 20-minute split-belt treadmill training session in individuals with anterior cruciate ligament (ACL) reconstruction. Individuals ~6-10 months after ACL reconstruction will be randomly assigned to 1 of 2 groups and each group will complete a split-belt and tied-belt session. One group will train the early stance knee moment with split-belt walking, while the other group will train the mid-stance knee moment with split-belt walking. Both groups will also complete a tied-belt session. Bilateral knee loading will be quantified using peak knee moments before training (10 min), during training (20 min), and after training (10 min). The investigators hypothesize that the training-mediated aftereffects (i.e., loading after training) will be significantly higher in the split-belt condition than in the tied-belt control condition. The investigators also hypothesize that early stance split-belt training will lead to training-mediated aftereffects for the early stance moment only, while mid-stance training will only result in aftereffects for the mid-stance knee moment.
- Conditions
- ACL, ACL Injury
- Being tested
- Split-belt Training, Tied-Belt Training
- Keywords
- Biomechanics, Knee loading, Split-belt, 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.
Split-belt TrainingBehavioural
Walking on a split-belt treadmill in which the speed of one belt will be different (move faster or slower) than the speed of the other belt.
Tied-Belt TrainingBehavioural
Walking on a split-belt treadmill in which the speed of both belts is the same.
| Study group | Role | What they receive |
|---|---|---|
| Early Stance Training | Experimental | This study arm will complete both a 20-minute split-belt \& tied-belt session. During the split-belt session, the ACL limb will walk at a faster speed (150-170% of 1.1 m/s) than the non-ACL limb (1.1 m/s). During the tied-belt session both limbs will walk at the same speed which will be set to match the faster speed of the ACL leg from the split-belt training day. Receives: Behavioral: Split-belt Training; Behavioral: Tied-Belt Training |
| Mid-Stance Training | Experimental | This study arm will complete both a 20-minute split-belt \& tied-belt session. During the split-belt session, the ACL limb will walk at a slower speed (30-50% of 1.1 m/s) than the non-ACL limb (1.1 m/s). During the tied-belt session both limbs will walk at the same speed which will be set to match the slower speed of the ACL leg from the split-belt training day. Receives: Behavioral: Split-belt Training; Behavioral: Tied-Belt Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACL Limb Sagittal Plane Knee Joint Moment
Peak sagittal plane knee moment recorded from the ACL limb during walking gait
Measured: Before (10min), during (20min), & after training (10min)
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 start29 Oct 2024
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
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
- None (open label)
- Enrolment
- 32 participants (actual)
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
- NCT06529679
- Sponsor's protocol ID
- HUM00221406_Aim2
- Other IDs
- 1R21AR082643
- Acronym
- Mi-SPA
- Status last verified
- Apr 2026
- First submitted
- 26 Jul 2024
- Last updated
- 5 May 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 5 May 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 2)
- ClinicalTrials.gov ID
- NCT06529679
- Acronym / sponsor ID
- Mi-SPA / HUM00221406_Aim2
- Conditions
- ACL, ACL Injury
- Keywords
- Biomechanics, Knee loading, Split-belt, Asymmetric Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- 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 determine short-term adaptations (aftereffects) in knee loading after a 20-minute split-belt treadmill training session in patients with ACL reconstruction.
Our main question for this aim are:
- Are training-mediated aftereffects in the knee joint moment greater for tied-belt walking or split-belt walking?
- Are training-mediated aftereffects in the knee joint moment different between subjects who train early stance knee loading versus subjects who train mid-stance knee loading?
Detailed description
Knee and limb underloading are ubiquitous after anterior cruciate ligament (ACL) reconstruction and fails to resolve with the standard of care rehabilitation. This underloading behavior is clinically concerning and considered maladaptive, as it affects patient function, has been linked to risk for re-injury, and appears to be a precursor for post-traumatic knee osteoarthritis that affects upwards of 50% of patients who undergo an ACL 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 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.
The aim of this project is to determine short-term adaptations (aftereffects) in knee loading after a 20-minute split-belt treadmill training session in individuals with anterior cruciate ligament (ACL) reconstruction. Individuals ~6-10 months after ACL reconstruction will be randomly assigned to 1 of 2 groups and each group will complete a split-belt and tied-belt session. One group will train the early stance knee moment with split-belt walking, while the other group will train the mid-stance knee moment with split-belt walking. Both groups will also complete a tied-belt session. Bilateral knee loading will be quantified using peak knee moments before training (10 min), during training (20 min), and after training (10 min). The investigators hypothesize that the training-mediated aftereffects (i.e., loading after training) will be significantly higher in the split-belt condition than in the tied-belt control condition. The investigators also hypothesize that early stance split-belt training will lead to training-mediated aftereffects for the early stance moment only, while mid-stance training will only result in aftereffects for the mid-stance knee moment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Stance Training | Experimental | Behavioral: Split-belt Training, Behavioral: Tied-Belt TrainingThis study arm will complete both a 20-minute split-belt \& tied-belt session. During the split-belt session, the ACL limb will walk at a faster speed (150-170% of 1.1 m/s) than the non-ACL limb (1.1 m/s). During the tied-belt session both limbs will walk at the same speed which will be set to match the faster speed of the ACL leg from the split-belt training day. |
| Mid-Stance Training | Experimental | Behavioral: Split-belt Training, Behavioral: Tied-Belt TrainingThis study arm will complete both a 20-minute split-belt \& tied-belt session. During the split-belt session, the ACL limb will walk at a slower speed (30-50% of 1.1 m/s) than the non-ACL limb (1.1 m/s). During the tied-belt session both limbs will walk at the same speed which will be set to match the slower speed of the ACL leg from the split-belt training day. |
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 |
|---|---|---|
| Split-belt TrainingWalking on a split-belt treadmill in which the speed of one belt will be different (move faster or slower) than the speed of the other belt. | Behavioural | Early Stance Training, Mid-Stance Training |
| Tied-Belt TrainingWalking on a split-belt treadmill in which the speed of both belts is the same. | Behavioural | Early Stance Training, Mid-Stance Training |
Primary outcome
ACL Limb Sagittal Plane Knee Joint Moment
Time frame: Before (10min), during (20min), & after training (10min)
Peak sagittal plane knee moment recorded from the ACL limb during walking gait
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 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. This study is not recruiting at the moment.
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 and Tied-Belt Training in people with ACL and ACL Injury, 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: finished, as of the sponsor's last update on 5 May 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACL Limb Sagittal Plane Knee Joint Moment (time frame: Before (10min), during (20min), & after training (10min)). 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 5 May 2026.