Trial Outcomes & Findings for Vibratory Stimuli, A Novel Rehabilitation Method for Preventing Post - Traumatic Knee Osteoarthritis (NCT NCT02605876)
NCT ID: NCT02605876
Last Updated: 2019-11-19
Results Overview
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.
COMPLETED
NA
75 participants
Prior to and immediately following vibration interventions (within 5 minutes).
2019-11-19
Participant Flow
A convenience sample was recruited from local rehabilitation clinics, the University population, the local population, and a nearby Veterans Affairs Medical Center.
Participant milestones
| Measure |
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
|
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
|
Control
Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Whole Body Vibration
n=25 Participants
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
|
Local Muscle Vibration
n=25 Participants
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
|
Control
n=25 Participants
Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
75 Participants
n=75 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=75 Participants
|
|
Age, Continuous
|
20 years
STANDARD_DEVIATION 2 • n=25 Participants
|
20 years
STANDARD_DEVIATION 3 • n=25 Participants
|
21 years
STANDARD_DEVIATION 4 • n=25 Participants
|
21 years
STANDARD_DEVIATION 3 • n=75 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
17 Participants
n=25 Participants
|
54 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
21 Participants
n=75 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
75 Participants
n=75 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Whole Body Vibration
n=25 Participants
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
|
Local Muscle Vibration
n=25 Participants
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
|
Control
n=25 Participants
Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
|
|---|---|---|---|
|
Linear Ground Reaction Force Loading Rate
|
0.276 multiples of body weight per second
Interval 0.001 to 0.55
|
-0.146 multiples of body weight per second
Interval -0.431 to 0.138
|
-0.135 multiples of body weight per second
Interval -0.409 to 0.14
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Whole Body Vibration
n=25 Participants
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
|
Local Muscle Vibration
n=25 Participants
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
|
Control
n=25 Participants
Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
|
|---|---|---|---|
|
Quadriceps Strength
|
0.05 Newton*meters/kilogram body mass
Interval -0.04 to 0.15
|
-0.13 Newton*meters/kilogram body mass
Interval -0.23 to -0.03
|
-0.09 Newton*meters/kilogram body mass
Interval -0.19 to 0.01
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Whole Body Vibration
n=25 Participants
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
|
Local Muscle Vibration
n=25 Participants
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
|
Control
n=25 Participants
Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
|
|---|---|---|---|
|
Knee Proprioception
|
-0.71 degrees
Interval -1.15 to -0.27
|
-0.61 degrees
Interval -1.06 to -0.16
|
-0.08 degrees
Interval -0.53 to 0.38
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Whole Body Vibration
n=25 Participants
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
|
Local Muscle Vibration
n=25 Participants
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
|
Control
n=25 Participants
Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
|
|---|---|---|---|
|
Instantaneous Ground Reaction Force Loading Rate
|
-0.333 multiples of body weight per second
Interval -2.382 to 1.715
|
-3.552 multiples of body weight per second
Interval -5.671 to -1.434
|
0.473 multiples of body weight per second
Interval -1.587 to 2.532
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Whole Body Vibration
n=25 Participants
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
|
Local Muscle Vibration
n=25 Participants
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
|
Control
n=25 Participants
Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
|
|---|---|---|---|
|
Peak Internal Knee Extension Moment
|
0.271 % body weight x height
Interval 0.062 to 0.48
|
0.014 % body weight x height
Interval -0.204 to 0.233
|
-0.17 % body weight x height
Interval -0.386 to 0.043
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Whole Body Vibration
n=25 Participants
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
|
Local Muscle Vibration
n=25 Participants
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
|
Control
n=25 Participants
Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied.
|
|---|---|---|---|
|
Peak Internal Knee Valgus Moment
|
-0.450 % body weight x height
Interval -0.75 to -0.061
|
-0.436 % body weight x height
Interval -0.795 to -0.077
|
-0.304 % body weight x height
Interval -0.66 to 0.051
|
Adverse Events
Whole Body Vibration
Local Muscle Vibration
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Troy Blackburn
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place