AI Driven Biofeedback Wearable

Mayo Clinic

Status: Completed

Conditions: Knee Injuries

Treatments: Device: Biofeedback Knee Sleeve; Device: Sham Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04921410

21-004218

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups

Biofeedback Sleeve Effects on Preventive Biomechanics

Experimental group

Description:

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.

Treatment:

Device: Biofeedback Knee Sleeve

Sham Biofeedback

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Biofeedback