Optimizing Movement After Anterior Cruciate Ligament Injury

NCT05363683 | Completed Results

• 2 other identifiers: 0652-21-FBU54GM115458
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Knee Flexion Moment Impulse

  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.

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

• Cartilage T2 Relaxation Time

  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.

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

Secondary Outcomes (7)

• Knee Flexion Moment Impulse

  6 months after anterior cruciate ligament reconstruction.

• Vertical Ground Reaction Force Impulse

  Immediately post-intervention (approximately 1 week after intervention)

• Vertical Ground Reaction Force Impulse

  6 months after anterior cruciate ligament reconstruction.

• Peak Knee Flexion Moment

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

• Peak Knee Flexion Moment

  6 months after anterior cruciate ligament reconstruction.

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard care

Procedure: Standard Care

Experimental

EXPERIMENTAL

Squat biofeedback intervention

Procedure: Squat Biofeedback

Interventions

Squat Biofeedback 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.

Experimental

Standard Care PROCEDURE

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

Control

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• 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.

  PMID: 40904719 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Osteoarthritis, Knee

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Elizabeth Wellsandt
• Organization: University of Nebraska Medical Center

elizabeth.wellsandt@unmc.edu

402-559-4309

Study Officials

• Elizabeth A Wellsandt, DPT, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 6, 2022
• Study Start: November 11, 2021
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: February 20, 2026
• Results First Posted: December 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)