AI Driven Biofeedback Wearable

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04921410
• Other study ID #: 21-004218
• Status: Completed
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: July 20, 2021

Study information

• Verified date: February 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Device:
• Biofeedback 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.
• Sham Biofeedback
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials