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The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Peter Andriacchi, Stanford University
ClinicalTrials.gov Identifier:
NCT01021111
First received: November 24, 2009
Last updated: March 15, 2017
Last verified: March 2017

November 24, 2009
March 15, 2017
November 2009
April 2011   (Final data collection date for primary outcome measure)
Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback [ Time Frame: 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.
  • Decrease in risk for ACL injury [ Time Frame: 3 months ]
  • Patient safety during use of intervention [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01021111 on ClinicalTrials.gov Archive Site
Thigh Coronal Angular Velocity After Feedback Training [ Time Frame: 1 day ]
How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second.
Change in knee kinematics [ Time Frame: 3 months ]
Not Provided
Not Provided
 
The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
  • Athletic Injuries
  • Sprains and Strains
  • Wounds and Injuries
  • Knee Injuries
Device: Activity 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.
Experimental: 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
Intervention: Device: Activity Training with Feedback
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
December 2014
April 2011   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01021111
SU-09242009-4061
16584 ( Other Identifier: Stanford University Institutional Review Board )
No
Not Provided
No
Not Provided
Thomas Peter Andriacchi, Stanford University
Stanford University
Not Provided
Principal Investigator: Thomas Peter Andriacchi Stanford University
Stanford University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP