The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Athletic Injuries Sprains and Strains Wounds and Injuries Knee Injuries |
Device: Anterior Cruciate Ligament Measurement and Feedback System |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury |
- 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 ]
- Change in knee kinematics [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Ariel Dowling, PhD | (908) 229-8208 | adowling@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Ariel Dowling, PhD 908-229-8208 adowling@stanford.edu | |
| Principal Investigator: Thomas Peter Andriacchi | |
| Principal Investigator: | Thomas Peter Andriacchi | Stanford University |
More Information
No publications provided
| Responsible Party: | Thomas Peter Andriacchi, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01021111 History of Changes |
| Other Study ID Numbers: | SU-09242009-4061, 16584 |
| Study First Received: | November 24, 2009 |
| Last Updated: | November 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Athletic Injuries Knee Injuries Sprains and Strains Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 16, 2013