AI Driven Biofeedback Wearable

Not Applicable

Completed

• Conditions: Knee Injuries
• Interventions: Device: Biofeedback Knee Sleeve; Device: Sham Biofeedback

• Registration Number: NCT04921410
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-10
• Study Start: 2021-07-20
• Primary Completion: 2021-07-20
• Study Completion: 2021-07-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Male or female, age 12 - 65 years old.
• Athlete at High School, Collegiate, Recreational, Olympic / Professional level.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback Sleeve Effects on Preventive Biomechanics	Biofeedback Knee Sleeve	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.
Sham Biofeedback	Sham Biofeedback	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Landing force	8-16 weeks	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States