Vibration for Post-traumatic Osteoarthritis Risk Following ACL Injury
This study is looking at how different types of vibration, along with standard rehabilitation, might help people who have had anterior cruciate ligament (ACL) reconstruction surgery. The goal is to see if Whole Body Vibration or Local Muscle Vibration can reduce the risk of developing post-traumatic osteoarthritis (a type of arthritis that can happen after an injury) and prevent another ACL injury. Researchers will compare these vibration methods to standard ACL rehabilitation. You might be able to join if you are between 16 and 35 years old and have had a specific type of ACL reconstruction surgery for the first time. Success will be measured by improvements in quadriceps muscle strength, how you walk, and other factors related to knee health over 12 months.
- Study design
- This is an interventional study with a planned enrollment of 114 participants. It compares standard rehabilitation to rehabilitation that includes either Whole Body Vibration or Local Muscle Vibration.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 12 months after their ACL reconstruction surgery to measure changes in muscle strength and knee movement.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury
At a glance
Conditions
NCT04875052
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
MOTION Science Institute
Chapel Hill, North Carolinastudy coordinator listed
Recruiting
Womack Army Medical Center
Chapel Hill, North Carolinastudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Troy Blackburn, PhD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill
Who to contact
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Inclusion
Exclusion
What this trial measures
- Quadriceps Isometric Peak Torque Limb Symmetry Index over the first 12 months following ACL reconstruction surgeryUp to 12 months post ACL reconstruction surgery
Quadriceps function will be assessed via maximal voluntary isometric knee extension efforts while patients are seated on a dynamometer with the knee in 90° of flexion. Peak torque will be normalized to body mass. The limb symmetry index will be calculated as the ratio of the ACLR limb to the contralateral limb.
- Change in peak internal knee extension moment during walking over the first 12 months following ACL reconstruction surgeryUp to 12 months post ACL reconstruction surgery
Three-dimensional walking gait biomechanics will be obtained a via a 10-camera motion capture system interfaced with force plates embedded in a walkway. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee extension moment will be identified during the first 50% of stance. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.
- Change in vertical ground reaction force instantaneous loading rate over the first 12 months following ACL reconstruction surgeryUp to 12 months post ACL reconstruction surgery
The vertical ground reaction force will be sampled from force plates embedded in a walkway during walking gait biomechanics. The instantaneous loading rate during the first 50% of stance will be calculated as the first time derivative of the force vs. time curve and normalized to body weight. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.
- Change in KOOS Knee-related Quality of Life Subscale over the first 12 months following ACL reconstruction surgeryUp to 12 months post ACL reconstruction surgery
The Knee Injury and Osteoarthritis Outcome Score (KOOS) survey will be administered electronically at all study visits. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.
- Change in T1rho relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgeryUp to 12 months post ACL reconstruction surgery
T1rho MRIs will be obtained to assess composition (i.e. proteoglycan concentration) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.
- Probability of attaining 90% single-leg hop symmetry at 12 months post-ACLR.Up to 12 months post ACL reconstruction surgery
Single-leg hop for distance will be assessed 12 months post-ACLR in both limbs. Limb symmetry will be calculated as ACLR/Contralateral, and the number of patients who attain 90% symmetry will be compared between the rehabilitation arms.
- Change in peak internal knee adduction moment during landing over the first 12 months following ACL reconstruction surgeryUp to 12 months post ACL reconstruction surgery
Three-dimensional kinematics and kinetics will be obtained during double-leg landing a via a 10-camera motion capture system interfaced with embedded force plates. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee adduction moment will be identified during the loading phase of landing (initial ground contact to peak knee flexion). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.
- Change in quadriceps muscle quality over the first 12 months following ACL reconstruction surgeryUp to 12 months post ACL reconstruction surgery
MRI-based calculation of % contractile tissue in each component of the quadriceps muscle