Anterior Cruciate Ligament InjuriesNCT05363683
Optimizing Movement After Anterior Cruciate Ligament Injury
A study testing Squat Biofeedback in people with Anterior Cruciate Ligament Injuries and Knee Osteoarthritis, run by University of Nebraska at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Knee Osteoarthritis
- What is being tested?
- Squat Biofeedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Acute anterior cruciate ligament (ACL) injury in the past 6 months
- ACL reconstruction in the past month or have a planned ACL reconstruction
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the 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.
- Being tested
- Squat Biofeedback, Standard Care
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squat BiofeedbackProcedure or surgery
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.
Standard CareProcedure or surgery
The intervention group will receive standard care post-operative physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard care Receives: Procedure: Standard Care |
| Experimental | Experimental | Squat biofeedback intervention Receives: Procedure: Squat Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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 6 months. 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.
Measured: 6 months after anterior cruciate ligament reconstruction.
Vertical Ground Reaction Force 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 vertical ground reaction force impulse was calculated. The interlimb ratio (injured limb / uninjured limb) of the vertical ground reaction force impulse during descent and ascent of bilateral squatting was analyzed at post-intervention. A value of 1 represents symmetric vertical ground reaction force impulse; a value less than 1 represents a smaller vertical ground reaction force impulse in the injured compared to uninjured limb.
Measured: Immediately post-intervention (approximately 1 week after intervention)
Vertical Ground Reaction Force 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 vertical ground reaction force impulse was calculated. The interlimb ratio (injured limb / uninjured limb) of the vertical ground reaction force impulse during descent and ascent of bilateral squatting was analyzed at 6 months. A value of 1 represents symmetric vertical ground reaction force impulse; a value less than 1 represents a smaller vertical ground reaction force impulse in the injured compared to uninjured limb.
Measured: 6 months after anterior cruciate ligament reconstruction.
Peak Knee Flexion Moment
Participants completed 5 valid trials of walking in each limb. The external knee flexion moment was calculated using an inverse dynamics approach. The interlimb ratio (injured limb / uninjured limb) of the peak knee flexion moment during walking was analyzed at post-intervention. A value of 1 represents symmetric peak knee flexion moment; a value less than 1 represents a smaller peak knee flexion moment in the injured compared to uninjured limb.
Measured: Immediately post-intervention (within approximately 1 week after completing intervention)
Peak Knee Flexion Moment
Participants completed 5 valid trials of walking in each limb. The external knee flexion moment was calculated using an inverse dynamics approach. The interlimb ratio (injured limb / uninjured limb) of the peak knee flexion moment during walking was analyzed at 6 months. A value of 1 represents symmetric peak knee flexion moment; a value less than 1 represents a smaller peak knee flexion moment in the injured compared to uninjured limb.
Measured: 6 months after anterior cruciate ligament reconstruction.
Quadriceps Strength
Participants completed 3 trials of maximal isometric quadriceps strength testing using an isokinetic dynamometer at each limb, with the best trial in each limb used for analysis. The interlimb ratio (injured limb / uninjured limb) of maximum quadriceps strength was analyzed at post-intervention. A value of 1 represents symmetric quadriceps strength; a value less than 1 represents less quadriceps strength in the injured compared to uninjured limb.
Measured: Immediately post-intervention (within approximately 1 week after completing intervention)
Quadriceps Strength
Participants completed 3 trials of maximal isometric quadriceps strength testing using an isokinetic dynamometer at each limb, with the best trial in each limb used for analysis. The interlimb ratio (injured limb / uninjured limb) of maximum quadriceps strength was analyzed at 6 months. A value of 1 represents symmetric quadriceps strength; a value less than 1 represents less quadriceps strength in the injured compared to uninjured limb.
Measured: 6 months after anterior cruciate ligament reconstruction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start11 Nov 2021
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Elizabeth A Wellsandt, DPT, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363683
- Sponsor's protocol ID
- 0652-21-FB
- Other IDs
- U54GM115458
- Status last verified
- Jun 2025
- First submitted
- 2 May 2022
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40904719
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Movement After Anterior Cruciate Ligament Injury
- ClinicalTrials.gov ID
- NCT05363683
- Acronym / sponsor ID
- 0652-21-FB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Posted 12 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Standard CareStandard care |
| Experimental | Experimental | Procedure: Squat BiofeedbackSquat biofeedback intervention |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Acute anterior cruciate ligament (ACL) injury in the past 6 months
- ACL reconstruction in the past month or have a planned ACL reconstruction
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Squat BiofeedbackThe 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. | Procedure or surgery | Experimental |
| Standard CareThe intervention group will receive standard care post-operative physical therapy. | Procedure or surgery | Control |
Primary outcome
Knee Flexion Moment Impulse
Time frame: 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.
Cartilage T2 Relaxation Time
Time frame: 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.
7 secondary outcomes
Knee Flexion Moment Impulse
Time frame: 6 months after anterior cruciate ligament reconstruction.
Vertical Ground Reaction Force Impulse
Time frame: Immediately post-intervention (approximately 1 week after intervention)
Vertical Ground Reaction Force Impulse
Time frame: 6 months after anterior cruciate ligament reconstruction.
Peak Knee Flexion Moment
Time frame: Immediately post-intervention (within approximately 1 week after completing intervention)
Peak Knee Flexion Moment
Time frame: 6 months after anterior cruciate ligament reconstruction.
Quadriceps Strength
Time frame: Immediately post-intervention (within approximately 1 week after completing intervention)
Quadriceps Strength
Time frame: 6 months after anterior cruciate ligament reconstruction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40904719Wellsandt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A Wellsandt, DPT, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Squat Biofeedback in people with Anterior Cruciate Ligament Injuries and Knee Osteoarthritis, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Flexion Moment Impulse (time frame: Immediately post-intervention (within approximately 1 week after completing intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05363683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.