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Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality

This study is currently recruiting participants.
Verified May 2017 by Children's Hospital Medical Center, Cincinnati
Sponsor:
ClinicalTrials.gov Identifier:
NCT02933008
First Posted: October 14, 2016
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
  Purpose
Traumatic, debilitating anterior cruciate ligament (ACL) injuries occur at a 2 to 10-fold greater rate in female than male athletes. Consequently, there is a larger population of females that endure significant pain, functional limitations, and radiographic signs of knee osteoarthritis (OA) within 12 to 20 years FOLLOWING injury. To reduce the burden of OA, The National Public Health Agenda for Osteoarthritis recommends expanding and refining evidence-based prevention of ACL injury. Specialized training that targets modifiable risk factors shows statistical efficacy in high-risk athletes; however, clinically meaningful reduction of risk has not been achieved. A critical barrier that limits successful training outcomes is the requirement of qualified instructors to deliver personalized, intuitive, and accessible feedback to young athletes. Thus, a key gap in knowledge is how to efficiently deliver objective, effective feedback during training for injury prevention. The investigators long-term goal is to reduce ACL injuries and the subsequent sequela in young female athletes. The overall objective of this proposal is to implement and test innovative augmented neuromuscular training (aNMT) techniques to enhance sensorimotor learning and reduce biomechanical risk factors for ACL injury. The rationale that underlies this proposal is that, after completion, the investigators will be equipped to more effectively deliver biofeedback and decelerate the trend of increasing ACL injury rates in female athletes. This contribution will be significant for the reduction of the long-term sequel following ACL injury in young females.

Condition Intervention
Injury of Anterior Cruciate Ligament Other: aNMT biofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Measure increased knee flexion [ Time Frame: 5 years ]
    purpose of this investigation is to determine the efficacy of aNMT biofeedback to improve high-risk landing mechanics both in a laboratory task and during sport-specific scenarios. Based on our preliminary data, we hypothesize that aNMT biofeedback will produce greater improvements in localized joint mechanics compared to neuromuscular training that incorporates sham feedback during the drop vertical jump (DVJ) task.


Secondary Outcome Measures:
  • Reduced knee abduction moment [ Time Frame: 5 years ]
    aNMT will produce improved localized joint mechanics and global injury risk techniques during sport-specific maneuvers assessed in immersive virtual environments compared to the sham feedback. The expected outcomes will support increased efficiency and enhanced efficacy of feedback for personalized and targeted injury prevention training.


Estimated Enrollment: 324
Study Start Date: December 2016
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aNMT Biofeedback
A group that will receive a neuromuscular training intervention that incorporates biofeedback training
Other: aNMT biofeedback
neuromuscular training intervention that incorporates biofeedback training
Sham Comparator: Sham
a group that will receive the same neuromuscular training intervention with sham feedback training.
Other: aNMT biofeedback
neuromuscular training intervention that incorporates biofeedback training

Detailed Description:
aNMT integrates biomechanical screening with state-of-the-art augmented reality headsets to display real-time feedback that maps complex biomechanical variables onto simple visual feedback stimuli that athletes "control" via their own movements. The central hypothesis is that aNMT biofeedback will improve joint mechanics in evidence-based measures collected in realistic, sport-specific virtual reality scenarios. Specifically, the purpose of this investigation is to determine the efficacy of aNMT biofeedback to improve high-risk landing mechanics both in a laboratory task and during sport-specific scenarios. Based on the investigator's preliminary data, the investigators hypothesize that aNMT biofeedback will produce greater improvements in localized joint mechanics compared to neuromuscular training that incorporates sham feedback during the drop vertical jump (DVJ) task. In the secondary Aim, the investigators hypothesize aNMT will produce improved localized joint mechanics and global injury risk techniques during sport-specific maneuvers assessed in immersive virtual environments compared to the sham feedback. The expected outcomes will support increased efficiency and enhanced efficacy of feedback for personalized and targeted injury prevention training. The positive impact will be the improvement of injury risk mechanics and the potential to reduce injury on the field of play. A randomized, repeated-measures design will be used to test the two hypotheses for Aim 1: First, that aNMT will produce greater improvements in localized joint mechanics compared to the sham feedback group during the DVJ task; second, based on the preliminary data the investigators expect that innovative aNMT will lead to graduated joint improvements and reduced global injury risk mechanics that will exceed the overall task transferred reductions in high risk biomechanics following 12 real-time biofeedback training sessions. Previously described techniques will be used to measure biomechanical risk factors during a DVJ task performed at the beginning and end of the 6-week pre-competition training period. Athletes will be randomized into one of two groups: 1) aNMT biofeedback or (2) sham (augmented reality glasses with a stimulus that will provide exercise repetition count). Each athlete, as well as the statisticians, will be blinded to the intervention. All athletes will receive 12 training sessions over a 6-week period during their pre-competition season and each of the groups will have longitudinal assessment of biomechanical outcome measures captured at each biofeedback session. A subset of up to 60 participants will be recruited to test and refine the biofeedback stimulus. These participants will come for a single study visit and will be randomly allocated to a biofeedback or sham biofeedback group. Some of these participants may receive a cross-over assignment where they complete both the biofeedback and the sham feedback tasks. These study participants will not participate in strength, virtual reality pre or post-testing.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • actively participate on the soccer, volleyball, or basketball team.

Exclusion Criteria:

  • do not participate on the soccer, volleyball, or basketball team.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933008


Contacts
Contact: Kim D Barber Foss, MS 513-636-5971 Kim.Foss@cchmc.org
Contact: Staci Thomas, MS 513-803-1636 staci.thomas@cchmc.org

Locations
United States, Ohio
Cincinanti Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kim D Barber Foss, MS    513-636-5971    kim.foss@cchmc.org   
Principal Investigator: Gregory D Myer, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Gregory D Myer, PhD Cincinnati Childrens Hospital
  More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02933008     History of Changes
Other Study ID Numbers: 2014-2946
First Submitted: March 7, 2016
First Posted: October 14, 2016
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: While study results will be released, individual subject data will remain de-identified.

Keywords provided by Children's Hospital Medical Center, Cincinnati:
ACL
biofeedback
injury prevention
virtual reality

Additional relevant MeSH terms:
Wounds and Injuries
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries