Knee InjuriesPhase 2ROBUSTNCT02754700
Real-time Optimized Biofeedback Utilizing Sport Techniques
A Phase 2 study testing Neuromuscular Training, Hip Focused ROBUST Training and Knee Focused ROBUST Training in people with Knee Injuries, run by High Point University.
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. Read more about this study
- Who is it for?
- Ages 9 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Neuromuscular Training, Hip Focused ROBUST Training and Knee Focused ROBUST Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to 1 Feb 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Currently participating on club or school sponsored soccer team
Who cannot join
- Current injury that limits participating in sport
- Male
- Cannot participate in a 6-week intervention due to time or other constraints
About this study
Official title: Effects of Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) Training on Risk of Anterior Cruciate Ligament Injury
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.
Read the 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
- Being tested
- Neuromuscular Training, Hip Focused ROBUST Training, Knee Focused ROBUST Training
- Keywords
- Anterior Cruciate Ligament
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular TrainingOther
Standardized, comprehensive neuromuscular training
Hip Focused ROBUST TrainingOther
Biofeedback training focused on the hip extensors
Knee Focused ROBUST TrainingOther
Biofeedback training focused on knee abduction
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback Hip | Experimental | Hip focused biofeedback with neuromuscular training Receives: Other: Hip Focused ROBUST Training |
| Biofeedback Knee | Experimental | Knee focused biofeedback with neuromuscular training Receives: Other: Knee Focused ROBUST Training |
| Neuromuscular Training | Active comparator | Neuromuscular Training component Receives: Other: Neuromuscular Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Ford, PhD, Principal investigator, High Point University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754700
- Sponsor's protocol ID
- R21AR069873
- Acronym
- ROBUST
- Status last verified
- Feb 2019
- First submitted
- 20 Apr 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 40234828Taylor 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.
PubMed 28173788
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) Training on Risk of Anterior Cruciate Ligament Injury
- ClinicalTrials.gov ID
- NCT02754700
- Acronym / sponsor ID
- ROBUST / R21AR069873
- Conditions
- Knee Injuries
- Keywords
- Anterior Cruciate Ligament
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- High Point UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Hip | Experimental | Other: Hip Focused ROBUST TrainingHip focused biofeedback with neuromuscular training |
| Biofeedback Knee | Experimental | Other: Knee Focused ROBUST TrainingKnee focused biofeedback with neuromuscular training |
| Neuromuscular Training | Active comparator | Other: Neuromuscular TrainingNeuromuscular Training component |
Who may qualify
- Ages
- 9 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Currently participating on club or school sponsored soccer team
Key exclusion criteria (3 listed)
- Current injury that limits participating in sport
- Male
- Cannot participate in a 6-week intervention due to time or other constraints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular TrainingStandardized, comprehensive neuromuscular training | Other | Neuromuscular Training |
| Hip Focused ROBUST TrainingBiofeedback training focused on the hip extensors | Other | Biofeedback Hip |
| Knee Focused ROBUST TrainingBiofeedback training focused on knee abduction | Other | Biofeedback Knee |
Primary outcome
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.
1 secondary outcome
Knee abduction load
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Derived from this study: PubMed 40234828Ford 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.
- Derived from this study: PubMed 28173788Taylor 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Ford, PhD principal investigator
High Point University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neuromuscular Training, Hip Focused ROBUST Training and Knee Focused ROBUST Training in people with Knee Injuries, run by High Point University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee abduction load (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02754700, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.