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AI Driven Biofeedback Wearable

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04921410
Enrollment
33
Registered
2021-06-10
Start date
2021-07-20
Completion date
2021-07-20
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injuries

Keywords

injury, prevention, biofeedback, knee, wearable, rehabilitation

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.

Interventions

DEVICEBiofeedback Knee Sleeve

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.

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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
3D Motion8-16 weeksLower limb kinetics and kinematics will be calculated with inverse dynamics from 3D motion capture.
Rate / Incidence of Knee Injury8-16 weeksKnee injuries will be reported via coach, athletic trainer, or medical staff

Secondary

MeasureTime frameDescription
Landing force8-16 weeksNon-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026