Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST)
Primary Purpose
Knee Injuries
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Neuromuscular Training
Hip Focused ROBUST Training
Knee Focused ROBUST Training
Sponsored by
About this trial
This is an interventional prevention trial for Knee Injuries focused on measuring Anterior Cruciate Ligament
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Biofeedback Hip
Biofeedback Knee
Neuromuscular Training
Arm Description
Hip focused biofeedback with neuromuscular training
Knee focused biofeedback with neuromuscular training
Neuromuscular Training component
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02754700
First Posted
April 20, 2016
Last Updated
February 20, 2019
Sponsor
High Point University
1. Study Identification
Unique Protocol Identification Number
NCT02754700
Brief Title
Real-time Optimized Biofeedback Utilizing Sport Techniques
Acronym
ROBUST
Official Title
Effects of Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) Training on Risk of Anterior Cruciate Ligament Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
High Point University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
Anterior Cruciate Ligament
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback Hip
Arm Type
Experimental
Arm Description
Hip focused biofeedback with neuromuscular training
Arm Title
Biofeedback Knee
Arm Type
Experimental
Arm Description
Knee focused biofeedback with neuromuscular training
Arm Title
Neuromuscular Training
Arm Type
Active Comparator
Arm Description
Neuromuscular Training component
Intervention Type
Other
Intervention Name(s)
Neuromuscular Training
Intervention Description
Standardized, comprehensive neuromuscular training
Intervention Type
Other
Intervention Name(s)
Hip Focused ROBUST Training
Intervention Description
Biofeedback training focused on the hip extensors
Intervention Type
Other
Intervention Name(s)
Knee Focused ROBUST Training
Intervention Description
Biofeedback training focused on knee abduction
Primary Outcome Measure Information:
Title
Knee abduction load
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Knee abduction load
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Ford, PhD
Organizational Affiliation
High Point University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28173788
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.
Results Reference
derived
Learn more about this trial
Real-time Optimized Biofeedback Utilizing Sport Techniques
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