Real-time Optimized Biofeedback Utilizing Sport Techniques

NCT ID: NCT02754700

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-02-01

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.

Conditions

Knee Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Biofeedback Hip

Hip focused biofeedback with neuromuscular training

Group Type: EXPERIMENTAL

Hip Focused ROBUST Training

Intervention Type: OTHER

Biofeedback training focused on the hip extensors

Biofeedback Knee

Knee focused biofeedback with neuromuscular training

Group Type: EXPERIMENTAL

Knee Focused ROBUST Training

Intervention Type: OTHER

Biofeedback training focused on knee abduction

Neuromuscular Training

Neuromuscular Training component

Group Type: ACTIVE_COMPARATOR

Neuromuscular Training

Intervention Type: OTHER

Standardized, comprehensive neuromuscular training

Interventions

Neuromuscular Training

Standardized, comprehensive neuromuscular training

Intervention Type: OTHER

Hip Focused ROBUST Training

Biofeedback training focused on the hip extensors

Intervention Type: OTHER

Knee Focused ROBUST Training

Biofeedback training focused on knee abduction

Intervention Type: OTHER

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

High Point University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Ford, PhD

Role: PRINCIPAL_INVESTIGATOR

High Point University

References

Ford KR, Taylor JB, Westbrook AE, Paterno MV, Huang B, Nguyen AD. Outcomes of a randomized controlled trial of neuromuscular training with real-time biofeedback in young female athletes. BMC Musculoskelet Disord. 2025 Apr 15;26(1):366. doi: 10.1186/s12891-025-08647-3.

Reference Type: DERIVED

PMID: 40234828 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28173788 (View on PubMed)

Other Identifiers

R21AR069873

Identifier Type: NIH

Identifier Source: org_study_id

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