Recruiting

Vibration

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT04875052

Conditions

Osteoarthritis, Knee

Anterior Cruciate Ligament Injuries

Post-traumatic Osteoarthritis

Quadriceps Muscle Atrophy

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Interventions

Experimental: Whole Body Vibration

Experimental: Local Muscle Vibration

Standard ACL Rehabilitation

Study Details

Brief 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.

Conditions

Osteoarthritis, Knee

Anterior Cruciate Ligament Injuries

Post-traumatic Osteoarthritis

Quadriceps Muscle Atrophy

Study ID

NCT04875052

Start date

Jan 11, 2021

Status verified date

May, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 16 to 35 years
  • Unilateral, primary ACLR with bone-patellar tendon-bone autograft

Exclusion Criteria:

  • History of prior ACL injury or revision ACLR
  • History of prior knee surgery
  • Requirement of multiple ligament surgery at time of ACLR
  • Concomitant injuries or surgical procedures at the time of ACLR that would delay early post-operative weight bearing based on surgeon recommendations (e.g. lower extremity fracture, intra-articular fracture, microfracture procedure)
  • 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
  • Prior diagnosis of radiographic OA in any joint of the lower extremity
  • History of neurological disorder (e.g. stroke, multiple sclerosis, etc.)
  • Contraindications for MRI (e.g. extreme claustrophobia, cardiac pacemaker, cochlear implant, metal foreign bodies, aneurism clip, etc.)
  • Pregnant or planning to become pregnant

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Experimental: 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.

Experimental: 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.

Standard 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.

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 ]
  • Change in peak internal knee extension moment during walking over the first 12 months following ACL reconstruction surgery [ Time Frame: Up to 12 months post ACL reconstruction surgery ]
  • Change in vertical ground reaction force instantaneous loading rate over the first 12 months following ACL reconstruction surgery [ Time Frame: Up to 12 months post ACL reconstruction surgery ]
  • Change in KOOS Knee-related Quality of Life Subscale over the first 12 months following ACL reconstruction surgery [ Time Frame: Up to 12 months post ACL reconstruction surgery ]
  • Change in T1rho relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery [ Time Frame: Up to 12 months post ACL reconstruction surgery ]
  • Probability of attaining 90% single-leg hop symmetry at 12 months post-ACLR. [ Time Frame: Up to 12 months post ACL reconstruction surgery ]
  • Change in peak internal knee adduction moment during landing over the first 12 months following ACL reconstruction surgery [ Time Frame: Up to 12 months post ACL reconstruction surgery ]
  • Change in quadriceps muscle quality over the first 12 months following ACL reconstruction surgery [ Time Frame: Up to 12 months post ACL reconstruction surgery ]

Central Contacts and Locations

Central contacts

Troy Blackburn, PhD

919-843-2021troyb@email.unc.edu

Locations

MOTION Science Institute

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Troy Blackburn, PhD

troyb@email.unc.edu

Principal Investigator:

Blackburn

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

May 31, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-05-31.