Real-time Optimized Biofeedback Utilizing Sport Techniques

Knee Injuries Clinical Trial

— ROBUST  

Official title:

Effects of Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) Training on Risk of Anterior Cruciate Ligament Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754700
• Other study ID #: R21AR069873
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: High Point University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Knee Injuries

Intervention

Other:
• Neuromuscular Training
Standardized, comprehensive neuromuscular training
• Hip Focused ROBUST Training
Biofeedback training focused on the hip extensors
• Knee Focused ROBUST Training
Biofeedback training focused on knee abduction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
High Point University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee abduction load	Knee abduction load will be the primary outcome measure. This is assessed with three-dimensional motion analysis techniques and a detailed full-body biomechanical model during dynamic landing tasks immediately before and after 6 weeks of the study intervention. The unit of measure for knee abduction load is Nm and will be normalized to participant mass when appropriate.	6 weeks
Secondary	Knee abduction load	Knee abduction load following a 6 month retention time will be the secondary outcome measure. This is assessed with three-dimensional motion analysis techniques and a detailed full-body biomechanical model during dynamic landing tasks following 6 months after study intervention. The unit of measure for knee abduction load is Nm and will be normalized to participant mass when appropriate.	6 months