Real-time Sensorimotor Feedback for Injury Prevention in Males Assessed in Virtual Reality
MaNMT
1 other identifier
interventional
380
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 27, 2021
January 1, 2021
4.9 years
May 24, 2019
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in knee flexion measured using motion analysis system
measurement of knee flexion pre and post intervention to determine any change
6 years
Secondary Outcomes (1)
Change in knee abduction moment measured using motion analysis system
6 years
Study Arms (2)
MaNMT Biofeedback
EXPERIMENTALA group that will receive a neuromuscular training intervention that incorporates biofeedback training
Sham
SHAM COMPARATORa group that will receive the same neuromuscular training intervention with sham feedback training.
Interventions
neuromuscular training intervention that incorporates biofeedback training
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory D Myer, PhD
Cincinnati Childrens Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Randomization and double blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2019
First Posted
August 28, 2019
Study Start
September 1, 2021
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 27, 2021
Record last verified: 2021-01