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临床试验/NCT06529679
NCT06529679已完成不适用

Mi-SPA: Michigan Split-belt Adaptation Paradigm to Improve Knee Loading After Anterior Cruciate Ligament Reconstruction (Aim 2)

University of Michigan1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年10月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
ACL Limb Sagittal Plane Knee Joint Moment

研究概览

简要总结

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?

详细描述

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 (i.e., 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 (i.e., 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • English-speaking

排除标准

  • 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
  • bony fracture accompanying ACL injury
  • patients who experienced a knee dislocation
  • patients who had their ACL reconstructed with an allograft
  • patients who underwent a multi-ligamentous and/or staged ACL reconstruction

研究组 & 干预措施

Early Stance Training

Experimental

This study arm will complete both a 20-minute split-belt & tied-belt session. During the split-belt session, the ACL limb will walk at a faster speed (150-170% of 1.1 m/s) than the non-ACL limb (1.1 m/s). During the tied-belt session both limbs will walk at the same speed which will be set to match the faster speed of the ACL leg from the split-belt training day.

干预措施: Split-belt Training (Behavioral)

Early Stance Training

Experimental

This study arm will complete both a 20-minute split-belt & tied-belt session. During the split-belt session, the ACL limb will walk at a faster speed (150-170% of 1.1 m/s) than the non-ACL limb (1.1 m/s). During the tied-belt session both limbs will walk at the same speed which will be set to match the faster speed of the ACL leg from the split-belt training day.

干预措施: Tied-Belt Training (Behavioral)

Mid-Stance Training

Experimental

This study arm will complete both a 20-minute split-belt & tied-belt session. During the split-belt session, the ACL limb will walk at a slower speed (30-50% of 1.1 m/s) than the non-ACL limb (1.1 m/s). During the tied-belt session both limbs will walk at the same speed which will be set to match the slower speed of the ACL leg from the split-belt training day.

干预措施: Split-belt Training (Behavioral)

Mid-Stance Training

Experimental

This study arm will complete both a 20-minute split-belt & tied-belt session. During the split-belt session, the ACL limb will walk at a slower speed (30-50% of 1.1 m/s) than the non-ACL limb (1.1 m/s). During the tied-belt session both limbs will walk at the same speed which will be set to match the slower speed of the ACL leg from the split-belt training day.

干预措施: Tied-Belt Training (Behavioral)

结局指标

主要结局

ACL Limb Sagittal Plane Knee Joint Moment

时间窗: Before (10min), during (20min), & after training (10min)

Peak sagittal plane knee moment recorded from the ACL limb during walking gait

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Riann Palmieri-Smith

Professor School of Kinesiology

University of Michigan

研究点 (1)

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