AI Driven Biofeedback Wearable

Study Overview
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Brief Summary
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The purpose of this study is to conduct a comprehensive clinical and biomechanical screening of high school, collegiate-level, recreational, and Olympic/professional-level athletes with the goal of identifying individual functional and performance deficits that lead to future injury.

Official Title
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Artificially Intelligent Biofeedback Sleeve for Prevention and Rehabilitation of Traumatic Knee Injury

Conditions
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Knee Injuries

Intervention / Treatment
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* Device: Biofeedback Knee Sleeve
* Device: Sham Biofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 12 - 65 years old. Athlete at High School, Collegiate, Recreational, Olympic / Professional level. Exclusion Criteria: Indidividual under 12 or over 65 years old. Lower extremity injury in the past 6 months. History of neurological disease, vestibular or visual disturbance. Any other pathology that would impair motor performance.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biofeedback Sleeve Effects on Preventive Biomechanics<br>Biofeedback wearable sleeve will be utilized in at least 2 groups of athletes. This randomized group will receive an 'active' wearable device. The device will be worn during regular sport practice sessions for 8-16 weeks. The device will provide haptic feedback directly associated with potentially injurious events as determined by previously established cut-off values and artificially-intelligent algorithms. | Device: Biofeedback Knee Sleeve<br>* The biofeedback knee sleeve is a device that is artificially-intelligent and utilizes determined cut-off values of knee motion and forces to determine whether a motion is 'good' or 'bad'. A 'bad' knee motion will provide a haptic output to the wearer (biofeedback) so that they can take note of what the previous motion was that caused the device to signal a warning.<br>|
| Sham Comparator: Sham Biofeedback<br>Biofeedback wearable sleeve will be utilized in at least 2 groups of athletes. This randomized group will receive a 'sham' wearable device. The device will be worn during regular sport practice sessions for 8-16 weeks. The device will provide random feedback at random intervals not directly associated with potentially injurious events. | Device: Sham Biofeedback<br>* The biofeedback knee sleeve is a device that is artificially-intelligent and utilizes determined cut-off values of knee motion and forces to determine whether a motion is 'good' or 'bad'. This intervention will provide sham biofeedback during training sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D Motion | Lower limb kinetics and kinematics will be calculated with inverse dynamics from 3D motion capture. | 8-16 weeks | 
| Rate / Incidence of Knee Injury | Knee injuries will be reported via coach, athletic trainer, or medical staff | 8-16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Landing force | Non-contact injuries to the lower limb are dependent on ground reaction force. As ground reaction force is minimized during landing, so is the risk for injury as lower forces are transmitted through the limb. | 8-16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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injury, prevention, biofeedback, knee, wearable, rehabilitation