Clinical trial NCT02754700: Real-time Optimized Biofeedback Utilizing Sport Techniques
Official title: Effects of Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) Training on Risk of Anterior Cruciate Ligament Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Injuries
Keywords: Anterior Cruciate Ligament
Lead sponsor: High Point University
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will identify the most optimal, focused approach for biofeedback in adolescent females at high risk for anterior cruciate ligament (ACL) injury. A six-week randomized, pre/post-testing design will be used to identify biofeedback training effects. The investigators will also determine the effects of hip strategy on retention of decreased knee abduction load with focused biofeedback. A six-month follow-up design will be used to test retention of real-time biofeedback intervention.

Detailed description: Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) represents an innovative new approach to reduce traumatic anterior cruciate ligament (ACL) injuries. Over the last four decades, these debilitating injuries have occurred at a 2 to 10-fold greater rate in female compared to male athletes with the highest prevalence occurring between the ages of 16-18 years. As a consequence, there is a large population of females that endure significant pain, functional limitations and knee osteoarthritis (OA) as early as 5 years after the initial unintentional injury. To reduce the burden of OA, The National Public Health Agenda for Osteoarthritis recommends both expanding and refining evidence-based prevention of ACL injury. There currently is a gap in knowledge regarding how to maximize the effectiveness of injury prevention training in young female athletes. The long-term goal is to reduce ACL injuries in young female athletes. The objective of this application is to increase the efficacy of biofeedback training to reduce the risk of ACL injury. This proposal tests the central hypothesis that biofeedback methodology is needed to maximize the effectiveness of neuromuscular prophylactic interventions. The rationale supporting this proposal is that once the proposed research is completed, health professionals will be more successful at preventing devastating ACL injuries through properly optimized and targeted biofeedback training for young at-risk females. This research is innovative because it represents a new and substantive departure from the status quo by recognizing the need to optimize the application of biofeedback training. The work will contribute clinically relevant data in support of a future more robust clinical trial. The proposed research will be significant because it will lead to reduced rates of ACL injury in young females. Reduction of female injury rates to equal that of males would allow females annually to continue the health benefits of sports participation and avoid the long-term complications of osteoarthritis, which occurs with a 10 to 100-fold greater incidence in ACL-injured than in uninjured athletes.

Eligibility criteria: Inclusion Criteria:

* Currently participating on club or school sponsored soccer team

Exclusion Criteria:

* Current injury that limits participating in sport
* Male
* Cannot participate in a 6-week intervention due to time or other constraints

Primary outcomes:
measure: Knee abduction load
timeFrame: 6 weeks
Secondary outcomes:
measure: Knee abduction load
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: High Point University
name: Kevin Ford, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor JB, Nguyen AD, Paterno MV, Huang B, Ford KR. Real-time optimized biofeedback utilizing sport techniques (ROBUST): a study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Feb 7;18(1):71. doi: 10.1186/s12891-017-1436-1.