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Optimizing Movement After Anterior Cruciate Ligament Injury

University of Nebraska logo

University of Nebraska

Status

Completed

Conditions

Anterior Cruciate Ligament Injuries
Knee Osteoarthritis

Treatments

Procedure: Standard Care
Procedure: Squat Biofeedback

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05363683
U54GM115458 (U.S. NIH Grant/Contract)
0652-21-FB

Details and patient eligibility

About

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.

Full description

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.

Enrollment

34 patients

Sex

All

Ages

13 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

34 participants in 2 patient groups

Control
Active Comparator group
Description:
Standard care
Treatment:
Procedure: Standard Care
Experimental
Experimental group
Description:
Squat biofeedback intervention
Treatment:
Procedure: Squat Biofeedback

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Elizabeth A Wellsandt, DPT, PhD; Robert Barber, MS

Data sourced from clinicaltrials.gov

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