Optimizing Movement After Anterior Cruciate Ligament Injury

NCT ID: NCT05363683

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2024-06-05

Brief Summary

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.

Detailed 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.

Conditions

Anterior Cruciate Ligament Injuries; Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control

Standard care

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: PROCEDURE

The intervention group will receive standard care post-operative physical therapy.

Experimental

Squat biofeedback intervention

Group Type: EXPERIMENTAL

Squat Biofeedback

Intervention Type: PROCEDURE

The intervention group will complete bilateral squats with each limb on a separate portable force plate. They will receive real-time visual feedback on a 32-inch screen during all squats. Biofeedback conditions will be progressed from simplest (ground reaction force only) to most complex (ground reaction force plus center of pressure). This intervention will be included in additional to standard care post-operative physical therapy.

Interventions

Squat Biofeedback

The intervention group will complete bilateral squats with each limb on a separate portable force plate. They will receive real-time visual feedback on a 32-inch screen during all squats. Biofeedback conditions will be progressed from simplest (ground reaction force only) to most complex (ground reaction force plus center of pressure). This intervention will be included in additional to standard care post-operative physical therapy.

Intervention Type: PROCEDURE

Standard Care

The intervention group will receive standard care post-operative physical therapy.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth A Wellsandt, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

References

Wellsandt MJ, Weldon N, Werner DM, McManigal ML, Tao MA, Rosenthal MD, Sajja BR, Wichman CS, Baker A, Johnson C, Specht Z, Weaver BA, Knarr B, Nabower C, Wellsandt E. Efficacy of a Squat Visual Biofeedback Program After ACL Reconstruction: Protocol for a Prospective, Parallel, Randomized Controlled Trial. Int J Sports Phys Ther. 2025 Sep 2;20(9):1364-1376. doi: 10.26603/001c.142879. eCollection 2025.

Reference Type: BACKGROUND

PMID: 40904719 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U54GM115458

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0652-21-FB

Identifier Type: -

Identifier Source: org_study_id