Anterior Cruciate Ligament InjuriesNCT04914689
External Focus of Attention Feedback to Reduce Risk of Non-contact ACL Injury
A study testing Internal focus of attention feedback, Visual internal focus of attention feedback and Auditory external focus of attention feedback in people with Anterior Cruciate Ligament Injuries, run by University of North Carolina, Charlotte at 1 site in United States.
Trial summary
Knee injuries, especially those to the ACL, are common among physically active people. Preventing these injuries from happening is critical to limiting the long-term pain, disability, and arthritis associated with these injuries. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Internal focus of attention feedback, Visual internal focus of attention feedback and Auditory external focus of attention feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to 31 Mar 2025
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- exercise 30+ minutes 3+ days/week
Who cannot join
- Body mass index >40 kg/m2
- History of lower extremity fracture or surgery to either limb
- History of ACL tear, meniscus, or collateral ligament injury at the knee to either limb
- History of ankle sprains to either limb
- History of musculoskeletal injury sustained in the 6 months prior to enrollment
- History of concussion or neurological disorders that may influence electroencephalography activity
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- Visual or hearing impairments that would limit receiving the appropriate feedback
- Inability to comprehend and repeat back directions in English
- Current smoker
Trial locations and contacts
1 site in 1 country.
About this study
Knee injuries, especially those to the ACL, are common among physically active people. Preventing these injuries from happening is critical to limiting the long-term pain, disability, and arthritis associated with these injuries. Our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns to prevent injury than current standard treatments. If you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as landing from a box and running and cutting. After this initial assessment, you will be randomly allocated to one of 3 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people land from a jump. Participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.
Read the detailed description
Despite the popularity of injury prevention programs, anterior cruciate ligament (ACL) injuries continue to occur at a rate of 250,000 per year in the United States. It is believed that 75% of these injuries are preventable, thus alternative strategies to reduce the risk of injury are necessary. One reason current prevention strategies are not wholly successful may be their reliance on internal focus of attention (InFOCUS) feedback, which constrains movement and increases injury risk. Our project will examine an alternative approach, testing two different modes of external focus of attention (ExFOCUS) feedback to remove constrains on the way people move to reduce injury risk. We will also examine cortical activity to determine if there are differences in neuroplasticity that occur following each form of feedback to better understand how each works. Collectively, the knowledge gained from this study will inform the development of programs to reduce injury risk.
Specific Aim 1: Determine ExFOCUS's ability to reduce the risk of noncontact ACL injury by retaining improved biomechanics compared to InFOCUS. Hypothesis 1.1: the combined auditory and visual ExFOCUS groups will demonstrate greater improvements in biomechanics and will retain these improvements 1 month after cessation of the intervention.
Specific Aim 2: Determine differences in the ability of the two modes (visual and auditory) of ExFOCUS to change biomechanics. Hypothesis 2.1: Auditory ExFOCUS feedback will elicit superior results compared to visual ExFOCUS feedback immediately following the intervention. Specific Aim 3: To quantify differences in cortical activity following external focus of attention and internal focus of attention feedback. Hypothesis 3.1: External focus of attention feedback will increase cortical activity in both groups while there will be no changes in cortical activity during internal focus of attention feedback Hypothesis 3.2: Auditory feedback will elicit greater changes in auditory regions of the brain, while visual feedback will elicit greater changes in regions of the brain responsible for processing visual information.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Internal focus of attention feedback, Visual internal focus of attention feedback, Auditory external focus of attention feedback
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal focus of attention feedbackOther
Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving mirror feedback. Participants will be instructed to perform each functional task in a manner that keeps their knee in line with their toes.
Visual internal focus of attention feedbackOther
Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving visual feedback via laser. Participants will be instructed to perform each functional task in a manner that does causes the laser to move up and down but not side-to-side.
Auditory external focus of attention feedbackOther
Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving auditory feedback. Participants will be instructed to perform each functional task in a manner that does not cause the auditory tool to elicit a noise.
| Study group | Role | What they receive |
|---|---|---|
| Internal focus of attention feedback | Active comparator | Participants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns. Receives: Other: Internal focus of attention feedback |
| Visual external focus of attention feedback | Experimental | Participants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser. Receives: Other: Visual internal focus of attention feedback |
| Auditory external focus of attention feedback | Experimental | Participants will complete 12 sessions over 3 weeks receiving auditory feedback of their movement patterns. Receives: Other: Auditory external focus of attention feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in lower extremity biomechanics during landing.
Hip and knee angles and loads measured via 3D biomechanics
Measured: 1-week post-intervention, 4-weeks post-intervention
Differences in biomechanical changes between visual and auditory external focus of attention feedback.
Hip and knee angles and loads measured via 3D biomechanics
Measured: 1-week post-intervention, 4-weeks post-intervention
Secondary outcomes (1)
Changes from baseline in cortical activity during landing
Electroencephalography recording of cortical activity during landing
Measured: 1-week post-intervention, 4-weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start15 Aug 2021
- Primary completion28 Feb 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Charlotte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbey Thomas, PhD, University of North Carolina, Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914689
- Sponsor's protocol ID
- 21-0283
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Focus of Attention Feedback to Reduce Risk of Non-contact ACL Injury
- ClinicalTrials.gov ID
- NCT04914689
- Acronym / sponsor ID
- 21-0283
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 7 Jun 2021 (actual)
- 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.
Knee injuries, especially those to the ACL, are common among physically active people. Preventing these injuries from happening is critical to limiting the long-term pain, disability, and arthritis associated with these injuries. Our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns to prevent injury than current standard treatments. If you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as landing from a box and running and cutting. After this initial assessment, you will be randomly allocated to one of 3 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people land from a jump. Participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.
Detailed description
Despite the popularity of injury prevention programs, anterior cruciate ligament (ACL) injuries continue to occur at a rate of 250,000 per year in the United States. It is believed that 75% of these injuries are preventable, thus alternative strategies to reduce the risk of injury are necessary. One reason current prevention strategies are not wholly successful may be their reliance on internal focus of attention (InFOCUS) feedback, which constrains movement and increases injury risk. Our project will examine an alternative approach, testing two different modes of external focus of attention (ExFOCUS) feedback to remove constrains on the way people move to reduce injury risk. We will also examine cortical activity to determine if there are differences in neuroplasticity that occur following each form of feedback to better understand how each works. Collectively, the knowledge gained from this study will inform the development of programs to reduce injury risk.
Specific Aim 1: Determine ExFOCUS's ability to reduce the risk of noncontact ACL injury by retaining improved biomechanics compared to InFOCUS. Hypothesis 1.1: the combined auditory and visual ExFOCUS groups will demonstrate greater improvements in biomechanics and will retain these improvements 1 month after cessation of the intervention.
Specific Aim 2: Determine differences in the ability of the two modes (visual and auditory) of ExFOCUS to change biomechanics. Hypothesis 2.1: Auditory ExFOCUS feedback will elicit superior results compared to visual ExFOCUS feedback immediately following the intervention. Specific Aim 3: To quantify differences in cortical activity following external focus of attention and internal focus of attention feedback. Hypothesis 3.1: External focus of attention feedback will increase cortical activity in both groups while there will be no changes in cortical activity during internal focus of attention feedback Hypothesis 3.2: Auditory feedback will elicit greater changes in auditory regions of the brain, while visual feedback will elicit greater changes in regions of the brain responsible for processing visual information.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internal focus of attention feedback | Active comparator | Other: Internal focus of attention feedbackParticipants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns. |
| Visual external focus of attention feedback | Experimental | Other: Visual internal focus of attention feedbackParticipants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser. |
| Auditory external focus of attention feedback | Experimental | Other: Auditory external focus of attention feedbackParticipants will complete 12 sessions over 3 weeks receiving auditory feedback of their movement patterns. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- exercise 30+ minutes 3+ days/week
Key exclusion criteria (9 listed)
- Body mass index >40 kg/m2
- History of lower extremity fracture or surgery to either limb
- History of ACL tear, meniscus, or collateral ligament injury at the knee to either limb
- History of ankle sprains to either limb
- History of musculoskeletal injury sustained in the 6 months prior to enrollment
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 |
|---|---|---|
| Internal focus of attention feedbackParticipants will complete 12 sessions over a 3-week period of functional movement retraining while receiving mirror feedback. Participants will be instructed to perform each functional task in a manner that keeps their knee in line with their toes. | Other | Internal focus of attention feedback |
| Visual internal focus of attention feedbackParticipants will complete 12 sessions over a 3-week period of functional movement retraining while receiving visual feedback via laser. Participants will be instructed to perform each functional task in a manner that does causes the laser to move up and down but not side-to-side. | Other | Visual external focus of attention feedback |
| Auditory external focus of attention feedbackParticipants will complete 12 sessions over a 3-week period of functional movement retraining while receiving auditory feedback. Participants will be instructed to perform each functional task in a manner that does not cause the auditory tool to elicit a noise. | Other | Auditory external focus of attention feedback |
Primary outcome
Changes from baseline in lower extremity biomechanics during landing.
Time frame: 1-week post-intervention, 4-weeks post-intervention
Hip and knee angles and loads measured via 3D biomechanics
Differences in biomechanical changes between visual and auditory external focus of attention feedback.
Time frame: 1-week post-intervention, 4-weeks post-intervention
Hip and knee angles and loads measured via 3D biomechanics
1 secondary outcome
Changes from baseline in cortical activity during landing
Time frame: 1-week post-intervention, 4-weeks post-intervention
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal focus of attention feedback, Visual internal focus of attention feedback and Auditory external focus of attention feedback in people with Anterior Cruciate Ligament Injuries, run by University of North Carolina, Charlotte at 1 site in United States.
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 9 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Changes from baseline in lower extremity biomechanics during landing. (time frame: 1-week post-intervention, 4-weeks post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.