- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05363683
Optimizing Movement After Anterior Cruciate Ligament Injury
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Standard care
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The intervention group will receive standard care post-operative physical therapy.
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Experimental: Experimental
Squat biofeedback intervention
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately post-intervention (within approximately 1 week after completing intervention)
|
|
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.
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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.
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Baseline (immediately before intervention, 2-6 weeks after anterior cruciate ligament reconstruction) and 6 months after anterior cruciate ligament reconstruction.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Flexion Moment Impulse
Time Frame: 6 months after anterior cruciate ligament reconstruction.
|
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.
|
6 months after anterior cruciate ligament reconstruction.
|
|
Vertical Ground Reaction Force Impulse
Time Frame: Immediately post-intervention (approximately 1 week after 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 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.
|
Immediately post-intervention (approximately 1 week after intervention)
|
|
Vertical Ground Reaction Force Impulse
Time Frame: 6 months after anterior cruciate ligament reconstruction.
|
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.
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6 months after anterior cruciate ligament reconstruction.
|
|
Peak Knee Flexion Moment
Time Frame: Immediately post-intervention (within approximately 1 week after completing intervention)
|
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.
|
Immediately post-intervention (within approximately 1 week after completing intervention)
|
|
Peak Knee Flexion Moment
Time Frame: 6 months after anterior cruciate ligament reconstruction.
|
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.
|
6 months after anterior cruciate ligament reconstruction.
|
|
Quadriceps Strength
Time Frame: Immediately post-intervention (within approximately 1 week after completing intervention)
|
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.
|
Immediately post-intervention (within approximately 1 week after completing intervention)
|
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Quadriceps Strength
Time Frame: 6 months after anterior cruciate ligament reconstruction.
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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.
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6 months after anterior cruciate ligament reconstruction.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth A Wellsandt, DPT, PhD, University of Nebraska
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Wounds and Injuries
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Leg Injuries
- Osteoarthritis
- Knee Injuries
- Anterior Cruciate Ligament Injuries
- Osteoarthritis, Knee
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Standard of Care
Other Study ID Numbers
- 0652-21-FB
- U54GM115458 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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