RecruitingNot ApplicableNCT04875052

Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

The Effects of Vibratory Stimuli on Joint Health and Post-traumatic Osteoarthritis Risk Following Anterior Cruciate Ligament Injury

Sponsor

University of North Carolina, Chapel Hill

Enrollment

114 participants

Start Date

Jan 11, 2021

Study Type

INTERVENTIONAL

Conditions

Osteoarthritis, Knee Post-traumatic Osteoarthritis Quadriceps Muscle Atrophy Anterior Cruciate Ligament Injuries

Summary

The goal of this randomized clinical trial is to evaluate the effects of vibration on factors related to the risks of post-traumatic knee osteoarthritis and secondary anterior cruciate ligament (ACL) injury in individuals who have undergone anterior cruciate ligament reconstruction surgery (ACLR). The main objectives are to compare the effects of Standard rehabilitation vs. rehabilitation that includes whole body vibration (WBV) or local muscle vibration (LMV) on: * Quadriceps muscle function * Gait biomechanics linked to post-traumatic knee osteoarthritis development * Patient self-report outcomes * MRI indicators of knee joint health and muscle quality * Landing biomechanics linked to secondary ACL injury risk * Evidence-based return-to-physical-activity criteria Participants will be assigned to 1 of 3 groups (standard rehabilitation, standard rehabilitation + WBV, or standard rehabilitation + LMV) and will complete assessments of quadriceps function, gait biomechanics, landing biomechanics, functional ability, patient-report outcomes, and MRI 1, 6, and 12 months after ACLR. Researchers will compare the groups to see if vibration embedded in ACLR rehabilitation improves joint health outcomes.

Eligibility

Min Age: 16 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This clinical study is investigating "Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury". Researchers are looking for volunteers to help improve understanding and treatments in this area. You may be eligible if: - You are between 16 Years and 35 Years - Unilateral, primary ACLR with bone-patellar tendon-bone autograft You may NOT be eligible if: - History of prior ACL injury or revision ACLR - History of prior knee surgery - Requirement of multiple ligament surgery at time of ACLR - Removal of more than 1/3 of the medial or lateral meniscus at the time of ACLR - Articular cartilage damage greater than 3A on the International Cartilage Repair Society Criteria at the time of ACLR - History of musculoskeletal injury to either leg in the 3 months prior to participation other than primary ACL injury Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExperimental: Whole Body Vibration

Whole body vibration will be delivered using a commercially available device at a frequency of 30Hz and acceleration of 2g for 1 minute a total of 6 times with 2 minutes of rest between exposures.

DEVICEExperimental: Local Muscle Vibration

Local muscle vibration will be delivered using a prototype device at a frequency of 30Hz and acceleration of 2g for 1 minute a total of 6 times with 2 minutes of rest between exposures.

OTHERStandard ACL Rehabilitation

Patients will complete a standard of care rehabilitation emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control.