Clinical Trials Logo
  1. Home
  2. Wounds and Injuries
  3. NCT01021111
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT04554212 - Blood Flow Restriction Training After Patellar INStability N/A
Suspended NCT02932176 - Machine Learning for Handheld Vascular Studies
Recruiting NCT04803253 - Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation N/A
Completed NCT00116337 - Spinal Cord Stimulation to Restore Cough N/A
Completed NCT04438174 - Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds Phase 1/Phase 2
Completed NCT03463720 - Outcome for Patients With War-Associated Extremity Wound Infection N/A
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Not yet recruiting NCT05492903 - COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP) N/A
Terminated NCT02909231 - One-year Patient Reported Outcomes Following Hospitalization for Trauma N/A
Completed NCT02432456 - Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients Phase 4
Completed NCT02266771 - Impact of V.A.C. Veraflo Therapy in Wounds Requiring Debridement Within an Orthopedic Practice N/A
Completed NCT02744144 - Wound Bacterial Microbiota and Their Antibiotic Resistance N/A
Completed NCT02394821 - Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide Phase 3
Not yet recruiting NCT01665963 - Efficacy of TopClosure(C)System in Healing Complicated Pacemaker Wounds N/A
Completed NCT00151112 - Comparison of Two Different Procedures for Plexus Anesthesia N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Recruiting NCT05800834 - Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds Phase 2
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Terminated NCT04775316 - Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing