- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04914689
External Focus of Attention Feedback to Reduce Risk of Non-contact ACL Injury
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28223
- UNC Charlotte
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- exercise 30+ minutes 3+ days/week
Exclusion Criteria:
- 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
- Visual or hearing impairments that would limit receiving the appropriate feedback
- Inability to comprehend and repeat back directions in English
- Current smoker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Internal focus of attention feedback
Participants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns.
|
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.
|
|
Experimental: Visual external focus of attention feedback
Participants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser.
|
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.
|
|
Experimental: Auditory external focus of attention feedback
Participants will complete 12 sessions over 3 weeks receiving auditory feedback of their movement patterns.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1-week post-intervention, 4-weeks post-intervention
|
|
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-week post-intervention, 4-weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline in cortical activity during landing
Time Frame: 1-week post-intervention, 4-weeks post-intervention
|
Electroencephalography recording of cortical activity during landing
|
1-week post-intervention, 4-weeks post-intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-0283
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.