Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT04875052
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental: Whole Body Vibration — DEVICE
    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.
  • Experimental: Local Muscle Vibration — DEVICE
    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.
  • Standard ACL Rehabilitation — OTHER
    Patients will complete a standard of care rehabilitation emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control.

Study Details

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.

Key Dates

Start date
Jan 11, 2021
Status verified
May 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard ACL Rehabilitation
    Patients will complete a 20-week supervised, progressive rehabilitation protocol directed by physical therapists at 1 of 3 participating clinics. While the specific rehabilitation exercises and techniques used for a given patient may vary depending on clinician preference/experience and patient responsiveness and progress, the general rehabilitation protocol will be standardized and follow current best practices emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control consistent with the Multicenter Orthopaedics Outcomes Network (MOON) rehabilitation protocol.
  • Experimental: Whole Body Vibration
    Patients will perform standard rehabilitation for the first month post-ACLR. At 1 month they will continue with standard rehabilitation, but will also be exposed to whole body vibration at the beginning of each session prior to rehabilitation exercises in an effort to enhance their efficacy.
  • Experimental: Local Muscle Vibration
    Patients will perform standard rehabilitation for the first month post-ACLR. At 1 month they will continue with standard rehabilitation, but will also be exposed to local muscle vibration at the beginning of each session prior to rehabilitation exercises in an effort to enhance their efficacy.

Primary Outcome Measure

Quadriceps Isometric Peak Torque Limb Symmetry Index over the first 12 months following ACL reconstruction surgery [ Time Frame: Up to 12 months post ACL reconstruction surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MOTION Science InstituteChapel HillNorth Carolina27599
Troy Blackburn, PhD
[email protected]
Blackburn (PRINCIPAL_INVESTIGATOR)
Womack Army Medical CenterChapel HillNorth Carolina27599
TROY BLACKBURN
[email protected]
9198432021

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MOTION Science Institute· Chapel Hill, NCWomack Army Medical Center· Chapel Hill, NC

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