Michigan Split-belt Treadmill Training Program to Improve Long-Term Knee Biomechanics After ACL Reconstruction
NCT Number: NCT06529692
Acronym: Mi-SPA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ACL|Anterior Cruciate Ligament|ACL Injury
Interventions: BEHAVIORAL: Placebo Split-Belt Training|BEHAVIORAL: Split-Belt Training
Sponsor: University of Michigan
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 9
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2026-08

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?

Primary Outcome Measures: 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 Outcome Measures: Non-ACL Leg Sagittal Plane Knee Moment, Peak Sagittal Plane Knee Moment recorded from the Non-ACL leg during walking gait, Before Training, midway through training (3 weeks), & after training (6 weeks)|ACL Leg Vertical Ground Reaction Force, Peak Vertical Ground Reaction Force recorded from the ACL leg during walking gait, Before Training, midway through training (3 weeks), & after training (6 weeks)|Non-ACL Leg Vertical Ground Reaction Force, Peak Vertical Ground Reaction Force recorded from the Non-ACL leg during walking gait, Before Training, midway through training (3 weeks), & after training (6 weeks)|ACL Leg Internal Knee Joint Contact Force, Internal knee joint reaction force for the ACL limb estimated using musculoskeletal modeling, Before Training, midway through training (3 weeks), & after training (6 weeks)|Non-ACL Leg Internal Knee Joint Contact Force, Internal knee joint reaction force for the Non-ACL limb estimated using musculoskeletal modeling, Before Training, midway through training (3 weeks), & after training (6 weeks)|Knee Injury and Osteoarthritis Outcome Score (KOOS), 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., Before Training, midway through training (3 weeks), & after training (6 weeks)|Medial Cartilage Thickness, Thickness of the cartilage from the medial femoral trochlea measured using ultrasound, Before (0 weeks) & after training (6 weeks)|Lateral Cartilage Thickness, Thickness of the cartilage from the lateral femoral trochlea measured using ultrasound, Before (0 weeks) & after training (6 weeks)