AI Driven Biofeedback Wearable
February 6, 2023 updated by: Clifton R. Haider, Mayo Clinic
Artificially Intelligent Biofeedback Sleeve for Prevention and Rehabilitation of Traumatic Knee Injury
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 65 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
|
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_COMPARATOR: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
3D Motion
Time Frame: 8-16 weeks
|
Lower limb kinetics and kinematics will be calculated with inverse dynamics from 3D motion capture.
|
8-16 weeks
|
|
Rate / Incidence of Knee Injury
Time Frame: 8-16 weeks
|
Knee injuries will be reported via coach, athletic trainer, or medical staff
|
8-16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8-16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Clifton Haider, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 20, 2021
Primary Completion (ACTUAL)
July 20, 2021
Study Completion (ACTUAL)
July 20, 2021
Study Registration Dates
First Submitted
June 1, 2021
First Submitted That Met QC Criteria
June 7, 2021
First Posted (ACTUAL)
June 10, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-004218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.