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NCT01021111 Clinical Trial

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

Wounds and Injuries Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01021111
Other study ID # SU-09242009-4061
Secondary ID 16584
Status Active, not recruiting
Phase Phase 1/Phase 2
First received November 24, 2009
Last updated June 11, 2013
Start date November 2009
Est. completion date December 2013

Study information
Verified date June 2013
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date December 2013
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Anterior Cruciate Ligament Measurement and Feedback System

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decrease in risk for ACL injury 3 months No
Primary Patient safety during use of intervention 3 months Yes
Secondary Change in knee kinematics 3 months No
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