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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01021111
First received: November 24, 2009
Last updated: June 11, 2013
Last verified: June 2013

November 24, 2009
June 11, 2013
November 2009
April 2011   (final data collection date for primary outcome measure)
  • Decrease in risk for ACL injury [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Patient safety during use of intervention [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01021111 on ClinicalTrials.gov Archive Site
Change in knee kinematics [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Athletic Injuries
  • Sprains and Strains
  • Wounds and Injuries
  • Knee Injuries
Device: Anterior Cruciate Ligament Measurement and Feedback System
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: Anterior Cruciate Ligament Measurement and Feedback System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2013
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

Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01021111
SU-09242009-4061, 16584
Not Provided
Stanford University
Stanford University
Not Provided
Principal Investigator: Thomas Peter Andriacchi Stanford University
Stanford University
June 2013

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