Michigan Split-belt Treadmill Training Program to Improve Acute Knee Biomechanics After ACL Reconstruction (Mi-SPA)

April 28, 2026 updated by: Riann Palmieri-Smith, University of Michigan

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:

  1. Are training-mediated aftereffects in the knee joint moment greater for tied-belt walking or split-belt walking?
  2. 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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Riann M Palmieri-Smith, PhD, ATC
  • Phone Number: 734-615-3154
  • Email: riannp@umich.edu

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early Stance Training
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.
Behavioral: Split-belt Training
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.
Behavioral: Tied-Belt Training
Walking on a split-belt treadmill in which the speed of both belts is the same.
Experimental: Mid-Stance Training
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.
Behavioral: Split-belt Training
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.
Behavioral: Tied-Belt Training
Walking on a split-belt treadmill in which the speed of both belts is the same.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Before (10min), during (20min), & after training (10min)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Non-ACL Limb Sagittal Plane Knee Joint Moment
Time Frame: Before (10min), during (20min), & after training (10min)
Peak sagittal plane knee moment recorded from the Non-ACL limb during walking gait
Before (10min), during (20min), & after training (10min)
ACL Limb Vertical Ground Reaction Force
Time Frame: Before (10min), during (20min), & after training (10min)
Peak vertical ground recorded from the ACL limb during walking gait
Before (10min), during (20min), & after training (10min)
Non-ACL Limb Vertical Ground Reaction Force
Time Frame: Before (10min), during (20min), & after training (10min)
Peak vertical ground recorded from the Non-ACL limb during walking gait
Before (10min), during (20min), & after training (10min)
ACL Limb Internal Knee Joint Reaction Force
Time Frame: Before (10min), during (20min), & after training (10min)
Internal knee joint reaction force for the ACL limb estimated using musculoskeletal modeling
Before (10min), during (20min), & after training (10min)
Non-ACL Limb Internal Knee Joint Reaction Force
Time Frame: Before (10min), during (20min), & after training (10min)
Internal knee joint reaction force for the Non-ACL limb estimated using musculoskeletal modeling
Before (10min), during (20min), & after training (10min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chandramouli Krishnan, PT, PhD, University of Michigan
  • Principal Investigator: Riann M Palmieri-Smith, PhD, ATC, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00221406_Aim2
  • 1R21AR082643 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made publicly available via Deep Blue Data which is managed by the University of Michigan.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings