Squat Biofeedback for Anterior Cruciate Ligament Tear

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Nebraska Medical Center, Omaha, NE
Anterior Cruciate Ligament Tear+3 More
Squat Biofeedback - Procedure
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

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. Articular cartilage degeneration is the hallmark sign 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. We 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 our 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. Our 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. Our 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 our work to prevent OA after ACL injury.

Eligible Conditions

  • Anterior Cruciate Ligament Tear
  • Knee

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 6 months after ACL reconstruction

Month 6
Cartilage T1rho relaxation time
Cartilage T2 relaxation time
Knee flexion moment impulse
Peak knee flexion moment
Quadriceps strength

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control
1 of 2
Experimental
1 of 2
Active Control
Experimental Treatment

34 Total Participants · 2 Treatment Groups

Primary Treatment: Squat Biofeedback · No Placebo Group · N/A

Experimental
Procedure
Experimental Group · 1 Intervention: Squat Biofeedback · Intervention Types: Procedure
Control
Procedure
ActiveComparator Group · 1 Intervention: Standard Care · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months after acl reconstruction
Closest Location: University of Nebraska Medical Center · Omaha, NE
Photo of university of nebraska medical center 1Photo of university of nebraska medical center 2Photo of university of nebraska medical center 3
2010First Recorded Clinical Trial
0 TrialsResearching Anterior Cruciate Ligament Tear
577 CompletedClinical Trials

Who is running the clinical trial?

University of NebraskaLead Sponsor
475 Previous Clinical Trials
1,135,470 Total Patients Enrolled
Elizabeth Wellsandt, DPT, PhDPrincipal InvestigatorUniversity of Nebraska

Eligibility Criteria

Age < 65 · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had an ACL reconstruction in the past month or you have a planned ACL reconstruction.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.