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| ID | Type | Description | Link |
|---|---|---|---|
| 16584 | Other Identifier | Stanford University Institutional Review Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity Training with Feedback | Experimental | Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity Training with Feedback | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Thigh Coronal Angular Velocity After Feedback Training | How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second. | 1 day |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Peter Andriacchi | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Activity Training With Feedback | Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities Anterior Cruciate Ligament Measurement and Feedback System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Activity Training With Feedback | Subjects who underwent activity training with feedback |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Mean | Standard Deviation | degrees | 1 day |
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1 day
Adverse events were monitored on the day of subject testing
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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 | Activity Training With Feedback | Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities Anterior Cruciate Ligament Measurement and Feedback System |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Thomas P. Andriacchi | Stanford University | 6507238024 | tandriac@stanford.edu |
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| ID | Term |
|---|---|
| D001265 | Athletic Injuries |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Knee Flexion Angle | Mean | Standard Deviation | degrees |
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| Trunk lean | Mean | Standard Deviation | degrees |
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| Thigh coronal angular velocity | Mean | Standard Deviation | degrees/second |
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| 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. | Posted | Mean | Standard Deviation | degrees/second | 1 day |
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| 0 |
| 17 |
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| 17 |
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