Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529692
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Michigan Split-belt Treadmill Training Program to Improve Long-Term Knee Biomechanics After ACL Reconstruction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mi-SPA Michigan Split-belt Adaptation Paradigm to Improve Knee Loading After Anterior Cruciate Ligament Reconstruction Aim 3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mi-SPA
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
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
Detailed Description:
It is commonplace for individuals after anterior cruciate ligament ACL reconstruction to shift mechanical demands away from their surgical knee and limb This manifests as diminished knee moments and vertical ground reaction forces in the ACL limb during everyday tasks eg walking running standing landing etc and persists for as long as 25 years after surgery This pattern of underloading is considered maladaptive as it has been linked to re-injury and biological markers that are consistent with the development of post-traumatic osteoarthritis that affects over 50 of knees 10-20 years after surgical reconstruction
Split-belt treadmill training is a gait retraining approach where treadmill belt speeds are decoupled ie one belt is set to move at a faster or slower speed than the other belt during walking Split-belt training is based on well-established motor learning principles such as error-based learning and variability of practice which can lead to locomotor adaptations In healthy individuals split-belt treadmill walking significantly increases from baseline knee moment impulses in the limb on the slow belt than on the fast belt during the braking and propulsive phases of gait Split-belt treadmill training has also shown promise in individuals with neurological deficits resulting in significant improvements in gait biomechanics after training
To explore the adaptations in loading from a 6-week split-belt training intervention the investigators will conduct a pilot randomized clinical trial design but data will only be collected on 9 total subjects Nine subjects will be randomized to one of 3 groups 1 early stance split-belt treadmill training 2 mid-stance split-belt treadmill training or 3 placebo split-belt treadmill training The primary outcome sagittal plane knee moment will be examined before midway after the 6-weeks of training Other outcomes vertical ground reaction force knee joint contact force and the Knee Injury and Osteoarthritis Outcome Score will be measured at the same timepoints Medial and lateral knee cartilage thickness are additional outcomes that will only be assessed before and after training
Split-belt treadmill training is a gait retraining approach where treadmill belt speeds are decoupled ie one belt is set to move at a faster or slower speed than the other belt during walking Split-belt training is based on well-established motor learning principles such as error-based learning and variability of practice which can lead to locomotor adaptations In healthy individuals split-belt treadmill walking significantly increases from baseline knee moment impulses in the limb on the slow belt than on the fast belt during the braking and propulsive phases of gait Split-belt treadmill training has also shown promise in individuals with neurological deficits resulting in significant improvements in gait biomechanics after training
To explore the adaptations in loading from a 6-week split-belt training intervention the investigators will conduct a pilot randomized clinical trial design but data will only be collected on 9 total subjects Nine subjects will be randomized to one of 3 groups 1 early stance split-belt treadmill training 2 mid-stance split-belt treadmill training or 3 placebo split-belt treadmill training The primary outcome sagittal plane knee moment will be examined before midway after the 6-weeks of training Other outcomes vertical ground reaction force knee joint contact force and the Knee Injury and Osteoarthritis Outcome Score will be measured at the same timepoints Medial and lateral knee cartilage thickness are additional outcomes that will only be assessed before and after training
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None