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NCT Number: NCT06529692

Michigan Split-belt Treadmill Training Program to Improve Long-Term Knee Biomechanics After ACL Reconstruction

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:

1. 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? 2. Are there differences in training-related knee loading changes between individuals trained in the early stance vs. midstance loading split-belt training?

Recruiting

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Key information

Age range

14 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Split-Belt Training

Behavioral

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 Training

Behavioral

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.

Primary outcomes

  1. 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

Other outcomes

  1. Non-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 from the Non-ACL leg during walking gait

  2. ACL Leg Vertical Ground Reaction Force

    Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)

    Peak Vertical Ground Reaction Force recorded from the ACL leg during walking gait

  3. Non-ACL Leg Vertical Ground Reaction Force

    Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)

    Peak Vertical Ground Reaction Force recorded from the Non-ACL leg during walking gait

  4. ACL Leg Internal Knee Joint Contact Force

    Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)

    Internal knee joint reaction force for the ACL limb estimated using musculoskeletal modeling

  5. Non-ACL Leg Internal Knee Joint Contact Force

    Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)

    Internal knee joint reaction force for the Non-ACL limb estimated using musculoskeletal modeling

  6. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Before Training, midway through training (3 weeks), & after training (6 weeks)

    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.

  7. Medial Cartilage Thickness

    Time frame: Before (0 weeks) & after training (6 weeks)

    Thickness of the cartilage from the medial femoral trochlea measured using ultrasound

  8. Lateral Cartilage Thickness

    Time frame: Before (0 weeks) & after training (6 weeks)

    Thickness of the cartilage from the lateral femoral trochlea measured using ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Alexa Johnson, PhD

CONTACT

[email protected]

734-615-1297

Riann M Palmieri-Smith, PhD, ATC

CONTACT

[email protected]

734-615-3154

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Mi-SPA: Michigan Split-belt Adaptation Paradigm to Improve Knee Loading After Anterior Cruciate Ligament Reconstruction (Aim 3)

Acronym: Mi-SPA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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