Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02754700
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
High Point University

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.

Condition or disease Intervention/treatment Phase
Knee Injuries Other: Neuromuscular Training Other: Hip Focused ROBUST Training Other: Knee Focused ROBUST Training Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) Training on Risk of Anterior Cruciate Ligament Injury
Study Start Date : April 2016
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biofeedback Hip
Hip focused biofeedback with neuromuscular training
Other: Hip Focused ROBUST Training
Biofeedback training focused on the hip extensors

Experimental: Biofeedback Knee
Knee focused biofeedback with neuromuscular training
Other: Knee Focused ROBUST Training
Biofeedback training focused on knee abduction

Active Comparator: Neuromuscular Training
Neuromuscular Training component
Other: Neuromuscular Training
Standardized, comprehensive neuromuscular training




Primary Outcome Measures :
  1. Knee abduction load [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Knee abduction load [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754700


Sponsors and Collaborators
High Point University
Investigators
Layout table for investigator information
Principal Investigator: Kevin Ford, PhD High Point University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: High Point University
ClinicalTrials.gov Identifier: NCT02754700    
Other Study ID Numbers: R21AR069873 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by High Point University:
Anterior Cruciate Ligament
Additional relevant MeSH terms:
Layout table for MeSH terms
Knee Injuries
Wounds and Injuries
Leg Injuries