Knee Osteoarthritis
Conditions
Keywords
anterior cruciate ligament reconstruction
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.
Interventions
DEVICEWhole body vibration
DEVICELocal muscle vibration
Sponsors
United States Department of Defense
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linear Ground Reaction Force Loading Rate | 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. |
| Quadriceps Strength | 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. |
| Knee Proprioception | 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. |
| Instantaneous Ground Reaction Force Loading Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Peak Internal Knee Extension Moment | 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. |
| Peak Internal Knee Valgus Moment | 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. |
Countries
United States
Participant flow
Recruitment details
A convenience sample was recruited from local rehabilitation clinics, the University population, the local population, and a nearby Veterans Affairs Medical Center.
Participants by arm
| Arm | Count |
|---|---|
| Whole Body Vibration Subjects will receive whole body vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.
Whole body vibration | 25 |
| Local Muscle Vibration Subjects will receive local muscle vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures.
Local muscle vibration | 25 |
| Control Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied. | 25 |
| Total | 75 |
Baseline characteristics
| Characteristic | Local Muscle Vibration | Control | Whole Body Vibration | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 25 Participants | 75 Participants |
| Age, Continuous | 20 years STANDARD_DEVIATION 3 | 21 years STANDARD_DEVIATION 4 | 20 years STANDARD_DEVIATION 2 | 21 years STANDARD_DEVIATION 3 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 25 Participants | 25 Participants | 25 Participants | 75 Participants |
| Sex: Female, Male Female | 19 Participants | 17 Participants | 18 Participants | 54 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 7 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Instantaneous Ground Reaction Force Loading Rate
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.
Time frame: Immediately prior to and following the interventions (within 5 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Whole Body Vibration | Instantaneous Ground Reaction Force Loading Rate | -0.333 multiples of body weight per second |
| Local Muscle Vibration | Instantaneous Ground Reaction Force Loading Rate | -3.552 multiples of body weight per second |
| Control | Instantaneous Ground Reaction Force Loading Rate | 0.473 multiples of body weight per second |
Primary
Knee Proprioception
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.
Time frame: Prior to and immediately following vibration interventions (within 5 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Whole Body Vibration | Knee Proprioception | -0.71 degrees |
| Local Muscle Vibration | Knee Proprioception | -0.61 degrees |
| Control | Knee Proprioception | -0.08 degrees |
Primary
Linear Ground Reaction Force Loading Rate
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.
Time frame: Prior to and immediately following vibration interventions (within 5 minutes).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Whole Body Vibration | Linear Ground Reaction Force Loading Rate | 0.276 multiples of body weight per second |
| Local Muscle Vibration | Linear Ground Reaction Force Loading Rate | -0.146 multiples of body weight per second |
| Control | Linear Ground Reaction Force Loading Rate | -0.135 multiples of body weight per second |
Primary
Quadriceps Strength
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.
Time frame: Prior to and immediately following vibration interventions (within 10 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Whole Body Vibration | Quadriceps Strength | 0.05 Newton*meters/kilogram body mass |
| Local Muscle Vibration | Quadriceps Strength | -0.13 Newton*meters/kilogram body mass |
| Control | Quadriceps Strength | -0.09 Newton*meters/kilogram body mass |
Secondary
Peak Internal Knee Extension Moment
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.
Time frame: Immediately prior to and following the interventions (within 5 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Whole Body Vibration | Peak Internal Knee Extension Moment | 0.271 % body weight x height |
| Local Muscle Vibration | Peak Internal Knee Extension Moment | 0.014 % body weight x height |
| Control | Peak Internal Knee Extension Moment | -0.17 % body weight x height |
Secondary
Peak Internal Knee Valgus Moment
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.
Time frame: Immediately prior to and following the interventions (within 5 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Whole Body Vibration | Peak Internal Knee Valgus Moment | -0.450 % body weight x height |
| Local Muscle Vibration | Peak Internal Knee Valgus Moment | -0.436 % body weight x height |
| Control | Peak Internal Knee Valgus Moment | -0.304 % body weight x height |