The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Recruitment for this clinical trial complete.   Updates will be made  to this page when the study completes data analysis and results become available. Please check back often and find out how these studies have contributed to generating new knowledge about diseases and conditions within the NIAMS mission area.

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Study Description

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 study is to increase the efficacy of biofeedback training to reduce the risk of ACL injury. This study tests the central hypothesis that biofeedback methodology is needed to maximize the effectiveness of neuromuscular prophylactic interventions.

This research will help health professionals be more successful at preventing devastating ACL injuries through properly optimized and targeted biofeedback training for young at-risk females. Specific Aim 1 will identify the most optimal, focused approach for biofeedback in adolescent females at high risk for ACL injury. A six-week randomized, pre/post-testing design will be used to identify biofeedback training effects. Specific Aim 2 will 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. 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 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:

Ages Eligible for Study:           9 Years to 19 Years (Child, Adult)

Sexes Eligible for Study:          Female

Accepts Healthy Volunteers:  Yes

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

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Single (Outcomes Assessor)

Primary Purpose: Prevention

Study Location(s):

High Point University, High Point, North Carolina, United States, 27268

Study Website:

https://clinicaltrials.gov/ct2/show/NCT02754700?term=NCT02754700&draw=2&rank=1

 

 

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