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Clinical Trials/NCT02605876
NCT02605876
Completed
N/A

Vibratory Stimuli: A Novel Rehabilitation Method for Preventing Post-traumatic Knee Osteoarthritis

University of North Carolina, Chapel Hill1 site in 1 country75 target enrollmentOctober 1, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University of North Carolina, Chapel Hill
Enrollment
75
Locations
1
Primary Endpoint
Linear Ground Reaction Force Loading Rate
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2015
End Date
December 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Linear Ground Reaction Force Loading Rate

Time Frame: Prior to and immediately following vibration interventions (within 5 minutes).

Change score (Post-Pre) for the ground reaction force during the first 50% of the stance phase calculated as the slope of the vertical ground reaction force time series curve from heelstrike to the first ground reaction force peak. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 8.5-9.5 multiples of body weight per second.

Knee Proprioception

Time Frame: Prior to and immediately following vibration interventions (within 5 minutes)

Change score (Post-Pre) for the absolute sagittal plane joint reposition error. This value, measured in degrees, represents the absolute difference between a target knee flexion angle and the angle the subject reproduces, and assesses how well the subject can perceive the position of his/her knee in space. Typical values for the raw scores (i.e. not change scores) range from 0.5 - 5 degrees.

Quadriceps Strength

Time Frame: Prior to and immediately following vibration interventions (within 10 minutes)

Change score (Post-Pre) for maximal isometric knee extension peak torque in Newton\*meters/kilogram body mass. Though a "normal" value has not been established, typical values for the raw values (i.e. not changes scores) range 1.5-3.5 Newton\*meters/kilogram body mass.

Instantaneous Ground Reaction Force Loading Rate

Time Frame: Immediately prior to and following the interventions (within 5 minutes)

Change score (Post-Pre) loading rate calculated as the peak of the first time derivative of the vertical ground reaction force time series curve during the first 50% of the stance phase. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 50-70 multiples of body weight per second.

Secondary Outcomes

  • Peak Internal Knee Extension Moment(Immediately prior to and following the interventions (within 5 minutes))
  • Peak Internal Knee Valgus Moment(Immediately prior to and following the interventions (within 5 minutes))

Study Sites (1)

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