Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality (MaNMT)
Primary Purpose
ACL Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MaNMT Biofeedback
Sponsored by
About this trial
This is an interventional prevention trial for ACL Injury focused on measuring ACL, Biofeedback, Injury Prevention, Virtual Reality
Eligibility Criteria
Inclusion Criteria: actively participate on the soccer, voleyball, or basketball team
Exclusion Criteria: do not participate on the soccer, voleyball, or basketball team
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
MaNMT Biofeedback
Sham
Arm Description
A group that will receive a neuromuscular training intervention that incorporates biofeedback training
a group that will receive the same neuromuscular training intervention with sham feedback training.
Outcomes
Primary Outcome Measures
Change in knee flexion measured using motion analysis system
measurement of knee flexion pre and post intervention to determine any change
Secondary Outcome Measures
Change in knee abduction moment measured using motion analysis system
measurement of knee abduction moment pre and post intervention to determine any change
Full Information
NCT ID
NCT04068701
First Posted
May 24, 2019
Last Updated
January 26, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT04068701
Brief Title
Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality
Acronym
MaNMT
Official Title
Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Even though females are 2- to 10-times more likely to suffer an anterior cruciate ligament (ACL) injury, males represent the largest population of total ACL injuries. Consequently, there is a larger population of males that endure significant pain, functional limitations, and radiographic signs of knee osteoarthritis (OA) within 12 to 20 years of 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 investiagator's long-term goal is to reduce ACL injuries and the subsequent sequela in young male athletes.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
Keywords
ACL, Biofeedback, Injury Prevention, Virtual Reality
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Randomization and double blind
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MaNMT Biofeedback
Arm Type
Experimental
Arm Description
A group that will receive a neuromuscular training intervention that incorporates biofeedback training
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
a group that will receive the same neuromuscular training intervention with sham feedback training.
Intervention Type
Other
Intervention Name(s)
MaNMT Biofeedback
Intervention Description
neuromuscular training intervention that incorporates biofeedback training
Primary Outcome Measure Information:
Title
Change in knee flexion measured using motion analysis system
Description
measurement of knee flexion pre and post intervention to determine any change
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Change in knee abduction moment measured using motion analysis system
Description
measurement of knee abduction moment pre and post intervention to determine any change
Time Frame
6 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
study is limited to male subjects
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: actively participate on the soccer, voleyball, or basketball team
Exclusion Criteria: do not participate on the soccer, voleyball, or basketball team
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim D Barber Foss, MS
Phone
5136365971
Email
kim.foss@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Staci Thomas, MS
Phone
513-803-1636
Email
Staci.Thomas@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D Myer, PhD
Organizational Affiliation
Cincinnati Childrens Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality
We'll reach out to this number within 24 hrs