AI Driven Biofeedback Wearable

NCT04921410 | Completed

• 1 other identifier: 21-004218
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries

Keywords

injury; prevention; biofeedback; knee; wearable; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 3D Motion

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

  8-16 weeks

• Rate / Incidence of Knee Injury

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

  8-16 weeks

Secondary Outcomes (1)

• Landing force

  8-16 weeks

Study Arms (2)

Biofeedback Sleeve Effects on Preventive Biomechanics

EXPERIMENTAL

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.

Device: Biofeedback Knee Sleeve

Sham Biofeedback

SHAM COMPARATOR

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.

Device: Sham Biofeedback

Interventions

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.

Biofeedback Sleeve Effects on Preventive Biomechanics

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.

Sham Biofeedback

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Knee Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Leg Injuries

Study Officials

• Clifton Haider, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 10, 2021
• Study Start: July 20, 2021
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)