Viewing Study NCT06529679



Ignite Creation Date: 2024-10-26 @ 3:36 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06529679
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-07-26

Brief Title: Michigan Split-belt Treadmill Training Program to Improve Acute 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 2
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 determine short-term adaptations aftereffects in knee loading after a 20-minute split-belt treadmill training session in patients with ACL reconstruction

Our main question for this aim are

1 Are training-mediated aftereffects in the knee joint moment greater for tied-belt walking or split-belt walking
2 Are training-mediated aftereffects in the knee joint moment different between subjects who train early stance knee loading versus subjects who train mid-stance knee loading
Detailed Description: Knee and limb underloading are ubiquitous after anterior cruciate ligament ACL reconstruction and fails to resolve with the standard of care rehabilitation This underloading behavior is clinically concerning and considered maladaptive as it affects patient function has been linked to risk for re-injury and appears to be a precursor for post-traumatic knee osteoarthritis that affects upwards of 50 of patients who undergo an ACL 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 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

The aim of this project is to determine short-term adaptations aftereffects in knee loading after a 20-minute split-belt treadmill training session in individuals with anterior cruciate ligament ACL reconstruction Individuals 6-10 months after ACL reconstruction will be randomly assigned to 1 of 2 groups and each group will complete a split-belt and tied-belt session One group will train the early stance knee moment with split-belt walking while the other group will train the mid-stance knee moment with split-belt walking Both groups will also complete a tied-belt session Bilateral knee loading will be quantified using peak knee moments before training 10 min during training 20 min and after training 10 min The investigators hypothesize that the training-mediated aftereffects ie loading after training will be significantly higher in the split-belt condition than in the tied-belt control condition The investigators also hypothesize that early stance split-belt training will lead to training-mediated aftereffects for the early stance moment only while mid-stance training will only result in aftereffects for the mid-stance knee moment

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