Clinical trial NCT02605876: Vibratory Stimuli, A Novel Rehabilitation Method for Preventing Post - Traumatic Knee Osteoarthritis
Official title: Vibratory Stimuli: A Novel Rehabilitation Method for Preventing Post-traumatic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: anterior cruciate ligament reconstruction
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2015-11-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the acute effects of vibration (whole body vibration and local muscle vibration) on quadriceps function, knee joint proprioception, and gait biomechanics linked to osteoarthritis development in individuals with anterior cruciate ligament reconstruction. Subjects will be randomly assigned to control (no vibration), whole body vibration, and local muscle vibration groups, and the aforementioned characteristics will be assessed prior to and following the respective interventions.

Detailed description: Quadriceps muscle dysfunction and proprioceptive deficits following knee injuries alter walking gait biomechanics in manners that contribute to development of knee osteoarthritis. Current rehabilitation techniques are minimally effective for addressing these complications and preventing knee osteoarthritis. Anterior cruciate ligament reconstruction dramatically increases the risk of knee osteoarthritis, and represents an ideal model for evaluating novel rehabilitation techniques for preventing knee osteoarthritis.

Direct (local muscle vibration) and indirect (whole body vibration) vibratory stimuli enhance quadriceps function and proprioception, and may improve rehabilitation and reduce the risk of knee osteoarthritis. The purpose of this investigation is to determine and compare the acute effects of whole body vibration and local muscle vibration on quadriceps function, knee proprioception, and gait biomechanics in individuals with anterior cruciate ligament reconstruction. The investigators hypothesize that vibratory stimuli will enhance quadriceps function, knee proprioception, and gait biomechanics in manners that would reduce the risk of developing knee osteoarthritis, and that whole body vibration and local muscle vibration will produce equivalent improvements in these characteristics.

Eligibility criteria: Inclusion Criteria:

* age 18-35 years
* undergone unilateral ACLR within 5 years prior to participation
* at least 6 months post-ACLR
* Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report survey Pain subscale score \> 53.1 and Symptom subscale score \> 44.9
* cleared by a physician for return to physical activity, and currently participating in at least 20 minutes of physical activity 3x per week.

Exclusion Criteria:

* central activation ratio (CAR) \> 95%
* history of ACL graft rupture or revision surgery, neurological disorder, or injury to either leg within 6 months prior to participation (other than the initial ACLR)

Primary outcomes:
measure: Linear Ground Reaction Force Loading Rate
timeFrame: Prior to and immediately following vibration interventions (within 5 minutes).
measure: Quadriceps Strength
timeFrame: Prior to and immediately following vibration interventions (within 10 minutes)
measure: Knee Proprioception
timeFrame: Prior to and immediately following vibration interventions (within 5 minutes)
measure: Instantaneous Ground Reaction Force Loading Rate
timeFrame: Immediately prior to and following the interventions (within 5 minutes)
Secondary outcomes:
measure: Peak Internal Knee Extension Moment
timeFrame: Immediately prior to and following the interventions (within 5 minutes)
measure: Peak Internal Knee Valgus Moment
timeFrame: Immediately prior to and following the interventions (within 5 minutes)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Neuromuscular Research Lab, University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Troy Blackburn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blackburn T, Padua DA, Pietrosimone B, Schwartz TA, Spang JT, Goodwin JS, Dewig DR, Johnston CD. Vibration improves gait biomechanics linked to posttraumatic knee osteoarthritis following anterior cruciate ligament injury. J Orthop Res. 2021 May;39(5):1113-1122. doi: 10.1002/jor.24821. Epub 2020 Aug 12.
citation: Blackburn JT, Pietrosimone B, Spang JT, Goodwin JS, Johnston CD. Somatosensory Function Influences Aberrant Gait Biomechanics Following Anterior Cruciate Ligament Reconstruction. J Orthop Res. 2020 Mar;38(3):620-628. doi: 10.1002/jor.24495. Epub 2019 Oct 24.
citation: Blackburn T, Pietrosimone B, Goodwin JS, Johnston C, Spang JT. Co-activation during gait following anterior cruciate ligament reconstruction. Clin Biomech (Bristol). 2019 Jul;67:153-159. doi: 10.1016/j.clinbiomech.2019.05.010. Epub 2019 May 9.