Recruiting

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

Sponsor:

University of Michigan

Code:

NCT06529692

Conditions

ACL

Anterior Cruciate Ligament

ACL Injury

Eligibility Criteria

Sex: All

Age: 14 - 45

Healthy Volunteers: Not accepted

Interventions

Placebo Split-Belt Training

Split-Belt Training

Study Details

Brief 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. 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?

Conditions

ACL

Anterior Cruciate Ligament

ACL Injury

Study ID

NCT06529692

Start date

Aug 13, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 14 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

9 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early Stance 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 150-170% of 1.1 m/s and the Non-ACL leg walking at 1.1 m/s.

experimental: Mid-Stance 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.

placebo comparator: Placebo 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.

Interventions

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.

Split-Belt Training

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 outcome measure

ACL Leg Sagittal Plane Knee Moment [ Time Frame: Before training, midway through training (3 weeks), & after training (6 weeks) ]

Central Contacts and Locations

Central contacts

Alexa Johnson, PhD

734-615-1297 akjohns@umich.edu

Riann M Palmieri-Smith, PhD, ATC

734-615-3154 riannp@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48176

Contacts

Riann Palmieri-Smith, PhD

7348343342 riannp@umich.edu

Alexa Johnson, PhD

734-615-1297 akjohns@med.umich.edu

Principal Investigator:

Riann Palmieri-Smith, PhD

More Information

Sponsor

University of Michigan

Last update posted

Sep 8, 2025

Last verified

Aug, 2025

Keywords

Biomechanics
Knee Loading
Split-Belt Treadmill
Asymmetric Walking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-09-08.