- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04068701
Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality (MaNMT)
January 26, 2021 updated by: Children's Hospital Medical Center, Cincinnati
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
380
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kim D Barber Foss, MS
- Phone Number: 5136365971
- Email: kim.foss@cchmc.org
Study Contact Backup
- Name: Staci Thomas, MS
- Phone Number: 513-803-1636
- Email: Staci.Thomas@cchmc.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria: actively participate on the soccer, voleyball, or basketball team
Exclusion Criteria: do not participate on the soccer, voleyball, or basketball team
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MaNMT Biofeedback
A group that will receive a neuromuscular training intervention that incorporates biofeedback training
|
neuromuscular training intervention that incorporates biofeedback training
|
Sham Comparator: Sham
a group that will receive the same neuromuscular training intervention with sham feedback training.
|
neuromuscular training intervention that incorporates biofeedback training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in knee flexion measured using motion analysis system
Time Frame: 6 years
|
measurement of knee flexion pre and post intervention to determine any change
|
6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in knee abduction moment measured using motion analysis system
Time Frame: 6 years
|
measurement of knee abduction moment pre and post intervention to determine any change
|
6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2021
Primary Completion (Anticipated)
August 1, 2026
Study Completion (Anticipated)
December 1, 2026
Study Registration Dates
First Submitted
May 24, 2019
First Submitted That Met QC Criteria
August 22, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0769 (Other Identifier: M D Anderson Cancer Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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