Overview

This trial is active, not recruiting.

Conditions athletic injuries, sprains and strains, wounds and injuries, knee injuries
Treatment anterior cruciate ligament measurement and feedback system
Phase phase 1/phase 2
Sponsor Stanford University
Start date November 2009
End date April 2011
Trial size 20 participants
Trial identifier NCT01021111, 16584, SU-09242009-4061

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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

Primary Outcomes

Measure
Decrease in risk for ACL injury
time frame: 3 months
Patient safety during use of intervention
time frame: 3 months

Secondary Outcomes

Measure
Change in knee kinematics
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
Principal investigator Thomas Peter Andriacchi
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Stanford University.