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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Body Vibration | Experimental | 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. |
|
| Local Muscle Vibration | Experimental | 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. |
|
| Control | No Intervention | Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole body vibration | Device |
| ||
| Local muscle vibration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Prior to and immediately following vibration interventions (within 5 minutes). |
| 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. | Prior to and immediately following vibration interventions (within 10 minutes) |
| 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. | Prior to and immediately following vibration interventions (within 5 minutes) |
| 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. | Immediately prior to and following the interventions (within 5 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Troy Blackburn, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuromuscular Research Lab, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41761462 | Derived | Dennis JD, Edison AE, Birchmeier TB, Pietrosimone BG, Blackburn JT. Whole Body Vibration Acutely Decreases Medial Tibiofemoral Contact Force During Walking Following Anterior Cruciate Ligament Reconstruction. J Orthop Res. 2026 Mar;44(3):e70166. doi: 10.1002/jor.70166. | |
| 32757272 | Derived | 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. |
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A convenience sample was recruited from local rehabilitation clinics, the University population, the local population, and a nearby Veterans Affairs Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Control | Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Local Muscle Vibration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | multiples of body weight per second | Prior to and immediately following vibration interventions (within 5 minutes). |
|
Each participant was enrolled in the study for approximately 3 weeks over which AEs were evaluated. No follow up assessments occurred once participation was complete. Participants were asked to follow up with research team in the event that they experienced any adverse events, but were not directly evaluated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Troy Blackburn | University of North Carolina at Chapel Hill | 9198432021 | troyb@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2019 | Oct 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Immediately prior to and following the interventions (within 5 minutes) |
| 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. | Immediately prior to and following the interventions (within 5 minutes) |
| 31608488 | Derived | 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. |
| 31121428 | Derived | 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. |
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 |
| BG002 | Control | Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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 |
| OG002 | Control | Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied. |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Newton*meters/kilogram body mass | Prior to and immediately following vibration interventions (within 10 minutes) |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | degrees | Prior to and immediately following vibration interventions (within 5 minutes) |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | multiples of body weight per second | Immediately prior to and following the interventions (within 5 minutes) |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | % body weight x height | Immediately prior to and following the interventions (within 5 minutes) |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | % body weight x height | Immediately prior to and following the interventions (within 5 minutes) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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 | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Control | Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D012216 |
| Rheumatic Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|