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OpenTrials
Completed

NCT Number: NCT04921410

AI Driven Biofeedback Wearable

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.

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Key information

Conditions

Knee Injuries Leg Injuries Wounds and Injuries

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biofeedback Knee Sleeve

Device

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.

Sham Biofeedback

Device

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.

Primary outcomes

  1. 3D Motion

    Time frame: 8-16 weeks

    Lower limb kinetics and kinematics will be calculated with inverse dynamics from 3D motion capture.

  2. Rate / Incidence of Knee Injury

    Time frame: 8-16 weeks

    Knee injuries will be reported via coach, athletic trainer, or medical staff

Secondary outcomes

  1. Landing force

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2021
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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