AI Driven Biofeedback Wearable

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-20

Study Completion Date

2021-07-20

Brief Summary

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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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Anesthesia

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Detailed Description

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Conditions

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Knee Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Biofeedback Sleeve Effects on Preventive Biomechanics

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.

Group Type EXPERIMENTAL

Biofeedback Knee Sleeve

Intervention Type 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

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.

Group Type SHAM_COMPARATOR

Sham Biofeedback

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes