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

NCT06529692 | Recruiting

• 2 other identifiers: HUM00221406_Aim31R21AR082643
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

Biomechanics; Knee Loading; Split-Belt Treadmill; Asymmetric Walking

Outcome Measures

Primary Outcomes (1)

• ACL Leg Sagittal Plane Knee Moment

  Peak Sagittal Plane Knee Moment recorded during walking gait

  Before training, midway through training (3 weeks), & after training (6 weeks)

Other Outcomes (8)

• Non-ACL Leg Sagittal Plane Knee Moment

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

• ACL Leg Vertical Ground Reaction Force

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

• Non-ACL Leg Vertical Ground Reaction Force

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

Study Arms (3)

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.

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.

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.

Behavioral: Placebo Split-Belt Training

Interventions

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.

Placebo Split-Belt Training

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.

Early Stance Training; Mid-Stance Training

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48176, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Riann M Palmieri-Smith, PhD, ATC

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Chandramouli Krishnan, PT, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexa Johnson, PhD

CONTACT

734-615-1297; akjohns@umich.edu

Riann M Palmieri-Smith, PhD, ATC

CONTACT

734-615-3154; riannp@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: August 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

US (1)