Michigan Split-belt Treadmill Training Program to Improve Long-Term Knee Biomechanics After ACL Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-45
SponsorUniversity of Michigan
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo Split-Belt Training
BehavioralWalking 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
BehavioralWalking 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.
Treatment groups
9 Participants
are divided into 3 treatment groupsGroup A: Early Stance TrainingExperimental treatment 1 intervention
Group B: Mid-Stance TrainingExperimental treatment 1 intervention
Group C: Placebo Split-Belt TrainingPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
ACL Leg Sagittal Plane Knee Moment
Peak Sagittal Plane Knee Moment recorded during walking gait
Time frame
Before training, midway through training (3 weeks), & after training (6 weeks)Other outcomes
1
Non-ACL Leg Sagittal Plane Knee Moment
Peak Sagittal Plane Knee Moment recorded from the Non-ACL leg during walking gait
Time frame
Before Training, midway through training (3 weeks), & after training (6 weeks)2
ACL Leg Vertical Ground Reaction Force
Peak Vertical Ground Reaction Force recorded from the ACL leg during walking gait
Time frame
Before Training, midway through training (3 weeks), & after training (6 weeks)3
Non-ACL Leg Vertical Ground Reaction Force
Peak Vertical Ground Reaction Force recorded from the Non-ACL leg during walking gait
Time frame
Before Training, midway through training (3 weeks), & after training (6 weeks)4
ACL Leg Internal Knee Joint Contact Force
Internal knee joint reaction force for the ACL limb estimated using musculoskeletal modeling
Time frame
Before Training, midway through training (3 weeks), & after training (6 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov