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Completed

NCT Number: NCT02605876

Vibratory Stimuli, A Novel Rehabilitation Method for Preventing Post - Traumatic Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuromuscular Research Lab, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Whole Body Vibration

Device

Local muscle vibration

Device

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Peak Internal Knee Extension Moment

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

    Change score (Post-Pre) for the peak internal knee extension moment during the first 50% of the stance phase. This value reflects the internal (i.e. muscle and other soft tissue) response to external loading of the knee joint in the sagittal plane of motion, and is indicative of quadriceps muscle function during walking. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 2-4 % body weight x height.

  2. Peak Internal Knee Valgus Moment

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

    Change score (Post-Pre) for the peak internal knee valgus moment during the first 50% of the stance phase. This value reflects the internal (i.e. muscle and other soft tissue) response to external loading of the knee joint in the frontal plane of motion, and is indicative of medial tibiofemoral joint loading during walking. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 2-4 % body weight x height.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2015
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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