Athletic Injuries, Knee Injuries, Sprains and Strains, Wounds and Injuries
Conditions
Brief summary
The overall goal of this project is to reduce the risk for anterior cruciate ligament injuries by designing a targeted intervention that will alter the known kinematic and kinetic risk factors associated with ACL injuries.
Detailed description
This study will address the following specific aims: 1) To optimize a wearable, targeted, active training feedback device to reduce the risk of ACL injury among healthy subjects by inducing patterns of movement that alter the known kinematic and kinetic risk factors associated with ACL injuries. 2) To evaluate the efficacy of the active device and determine if the device reduces the risk of ACL injury among healthy subjects by effectively inducing patterns of movement that alter the known kinematic and kinetic risk factors associated with ACL injuries.
Interventions
DEVICEActivity Training with Feedback
The feedback system consisted of three small inertial measurement units affixed on the chest, thigh, and shank segment respectively. These units were connected to a computer that recorded the signal from the inertial sensors at 240 Hz during the jump task. Using custom software, the knee flexion angle, trunk lean, and coronal thigh angular velocity were calculated immediately after the subject completed the jump trial. A projector was used to display the results of the jump analysis. It took less than 10 minutes to place this system on a subject and less than five seconds to analyze a jump.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
The ages would range from 18 to 65. Both male and female subjects will be enrolled, and ethnic backgrounds would be mixed.
Exclusion criteria
(i) chronic lower body pain (ii) recent surgery of the lower or upper body (limitation of range of motion) (iii) previous history of ligament, meniscal, or chondral injury requiring surgery to the lower limb (iv) inability to complete jumping tasks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback | 1 day | Knee flexion angle describes the angle between the tibia and femur during the activity. Trunk flexion is the angle between the shoulders and the hips during the activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thigh Coronal Angular Velocity After Feedback Training | 1 day | How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second. |
Countries
United States
Participant flow
Recruitment details
Participants were involved in sports involving jumping maneuvers at the recreational level and free of previous lower limb musculoskeletal injuries, surgery, or pain. Subjects were unaware of the goals of the study prior to the start of the testing session.
Participants by arm
| Arm | Count |
|---|---|
| Activity Training With Feedback Subjects who underwent activity training with feedback | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Activity Training With Feedback |
|---|---|
| Age, Continuous | 27.5 years STANDARD_DEVIATION 2.3 |
| Knee Flexion Angle | 88.8 degrees STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 7 Participants |
| Thigh coronal angular velocity | 67.7 degrees/second STANDARD_DEVIATION 49.7 |
| Trunk lean | 23.6 degrees STANDARD_DEVIATION 8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback
Knee flexion angle describes the angle between the tibia and femur during the activity. Trunk flexion is the angle between the shoulders and the hips during the activity.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Activity Training With Feedback | Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback | Knee Flexion Angle | 105.0 degrees | Standard Deviation 5.6 |
| Activity Training With Feedback | Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback | Trunk Lean | 41.0 degrees | Standard Deviation 3.8 |
Comparison: The values from the three jumps were averaged in order to have one mean value per subject per session. Paired Student t-tests (baseline vs. follow-up) were used to evaluate the effects of the training.p-value: <0.01t-test, 2 sided
Secondary
Thigh Coronal Angular Velocity After Feedback Training
How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity Training With Feedback | Thigh Coronal Angular Velocity After Feedback Training | 47.6 degrees/second | Standard Deviation 40.5 |
Comparison: The association between the change in the thigh coronal angular velocity from baseline to follow-up and the change in the knee abduction moment from baseline to follow-up was assessed with the Pearson correlation coefficient (R), alpha =0.05p-value: <0.05Pearson