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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06529692
Status
Recruiting
Apply to this trial

Conditions

  • ACL
  • ACL Injury
  • Anterior Cruciate Ligament

Eligibility Criteria

Sex
ALL
Age
14 Years - 45 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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?

Key Dates

Start date
Aug 13, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
9 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48176
Riann Palmieri-Smith, PhD
[email protected]
7348343342
Alexa Johnson, PhD
[email protected]
734-615-1297
Riann Palmieri-Smith, PhD (PRINCIPAL_INVESTIGATOR)

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