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临床试验/NCT05363683
NCT05363683
已完成
不适用

Optimizing Movement After Anterior Cruciate Ligament Injury

University of Nebraska1 个研究点 分布在 1 个国家目标入组 34 人2021年11月11日

概览

阶段
不适用
干预措施
Standard Care
疾病 / 适应症
Anterior Cruciate Ligament Injuries
发起方
University of Nebraska
入组人数
34
试验地点
1
主要终点
Cartilage T2 Relaxation Time
状态
已完成
最后更新
2个月前

概览

简要总结

Fifty percent of teenagers and young adults who suffer an anterior cruciate ligament (ACL) injury develop knee osteoarthritis (OA) within 15 years. The resulting pain, reduced quality-of-life, and increased risk for co-morbidity lead to substantial healthcare costs, inability to fulfill work and personal responsibilities, and reduced long-term health. Degeneration in articular cartilage, connective tissue that covers the ends of bones in the knee, is the hallmark of early OA development after knee injury. This deterioration can be measured by an imaging biomarker for OA development on quantitative magnetic resonance imaging (MRI). Harmful increases in MRI markers of the knee's articular cartilage occur within months of ACL injury and indicate preventative interventions should begin soon after injury. However, evidence-based interventions to prevent OA do not exist.

This project will challenge the traditional OA paradigm that too much joint loading (e.g. "wear and tear") causes cartilage breakdown. A multi-disciplinary team has developed a novel visual biofeedback paradigm using portable force plates that can increase knee loading during squats within a single session after ACL reconstruction (ACLR). This study will determine the efficacy of the visual biofeedback program initiated two weeks after ACLR by assessing movement biomechanics and MRI changes in cartilage after six months later. Successful completion of this project will establish the first rehabilitation intervention to effectively and optimally load the knee joint early after ACLR, providing the initial steps to prevent OA after ACL injury.

详细描述

Fifty percent of teenagers and young adults who suffer an anterior cruciate ligament (ACL) injury develop radiographic knee osteoarthritis (OA) within 15 years. The resulting pain, reduced quality-of-life, and increased risk for co-morbidity lead to substantial healthcare costs, inability to fulfill work and personal responsibilities, and reduced long-term health. Degeneration in articular cartilage, connective tissue that covers the ends of bones in the knee, is the hallmark of early OA development after knee injury. This deterioration can be measured by increased T2 and T1rho relaxation time on quantitative magnetic resonance imaging (MRI), an imaging biomarker for OA development. Harmful increases in MRI markers of the knee's articular cartilage occur within months of ACL injury and indicate preventative interventions should begin soon after injury. However, evidence-based interventions to prevent OA do not exist. The investigators have shown that after ACL reconstruction (ACLR), patients exhibit asymmetric movement patterns characterized by up to 62% lower knee joint loading during walking and squatting in the injured limb at two months after ACLR. These knee joint loading patterns remain 40% lower at six months. Emerging evidence suggests knee joint unloading patterns after ACL injury may increase the risk for OA development. Currently, no studies have examined the efficacy of movement-focused interventions during the first months after ACLR, which explains the lack of evidence-based interventions that successfully increase knee loading early after ACLR. This gap presents a barrier to the long-term goal of preventing OA in young, active individuals before irreversible knee degeneration occurs. This project will challenge the traditional OA paradigm that too much joint loading (e.g. "wear and tear") causes cartilage breakdown. The multi-disciplinary team spanning rehabilitation, orthopaedics, radiology and biomechanics has developed a novel visual biofeedback paradigm using portable force plates that can increase knee loading during squats within a single session after ACLR. This data suggest movement is modifiable using visual feedback, but its efficacy beyond a single training session is unknown. This study will determine the efficacy of the visual biofeedback program initiated two weeks after ACLR by assessing movement biomechanics and MRI changes in cartilage microstructure six months later. Successful completion of this project will establish the first rehabilitation intervention to effectively and optimally load the knee joint early after ACLR, providing the initial steps in the team's work to prevent OA after ACL injury.

注册库
clinicaltrials.gov
开始日期
2021年11月11日
结束日期
2024年6月5日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Acute anterior cruciate ligament (ACL) injury in the past 6 months
  • ACL reconstruction in the past month or have a planned ACL reconstruction

排除标准

  • Previous knee injury or surgery (contralateral knee)
  • Body mass index (BMI) over 35 kg/m2
  • Concomitant posterior cruciate ligament reconstruction or cartilage procedure that includes extended weight bearing restrictions and/or changes to cartilage structure
  • Current or planned pregnancy during study duratuiom

研究组 & 干预措施

Control

Standard care

干预措施: Standard Care

Experimental

Squat biofeedback intervention

干预措施: Squat Biofeedback

结局指标

主要结局

Cartilage T2 Relaxation Time

时间窗: Baseline (immediately before intervention, 2-6 weeks after anterior cruciate ligament reconstruction) and 6 months after anterior cruciate ligament reconstruction.

Percent change in cartilage T2 relaxation time will be measured by a magnetic resonance imaging (MRI) scan. A positive percent change represents longer (worse) T2 relaxation times at 6 months compared to baseline testing. The cartilage region reported is the weightbearing area of the medial femoral condyle.

Knee Flexion Moment Impulse

时间窗: Immediately post-intervention (within approximately 1 week after completing intervention)

Participants completed 3 sets of 5 bilateral bodyweight squats with arms crossed at the chest, with the middle 3 of each set (9 total) averaged and reported. The external knee flexion moment was calculated using an inverse dynamics approach. The interlimb ratio (injured limb / uninjured limb) of the knee flexion moment impulse during descent and ascent of bilateral squatting was analyzed at post-intervention. A value of 1 represents symmetric knee flexion moment impulse; a value less than 1 represents a smaller knee flexion moment impulse in the injured compared to uninjured limb.

次要结局

  • Vertical Ground Reaction Force Impulse(Immediately post-intervention (approximately 1 week after intervention))
  • Peak Knee Flexion Moment(Immediately post-intervention (within approximately 1 week after completing intervention))
  • Quadriceps Strength(Immediately post-intervention (within approximately 1 week after completing intervention))
  • Knee Flexion Moment Impulse(6 months after anterior cruciate ligament reconstruction.)
  • Vertical Ground Reaction Force Impulse(6 months after anterior cruciate ligament reconstruction.)
  • Peak Knee Flexion Moment(6 months after anterior cruciate ligament reconstruction.)
  • Quadriceps Strength(6 months after anterior cruciate ligament reconstruction.)

研究点 (1)

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