Back to resultsAI Driven Biofeedback Wearable
Primary Purpose
Knee Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofeedback Knee Sleeve
Sham Biofeedback
Sponsored by
About this trial
This is an interventional prevention trial for Knee Injuries focused on measuring injury, prevention, biofeedback, knee, wearable, rehabilitation
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Biofeedback Sleeve Effects on Preventive Biomechanics
Sham Biofeedback
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
3D Motion
Lower limb kinetics and kinematics will be calculated with inverse dynamics from 3D motion capture.
Rate / Incidence of Knee Injury
Knee injuries will be reported via coach, athletic trainer, or medical staff
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04921410
Brief Title
AI Driven Biofeedback Wearable
Official Title
Artificially Intelligent Biofeedback Sleeve for Prevention and Rehabilitation of Traumatic Knee Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
injury, prevention, biofeedback, knee, wearable, rehabilitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback Sleeve Effects on Preventive Biomechanics
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Biofeedback
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Biofeedback Knee Sleeve
Intervention Description
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
Intervention Name(s)
Sham Biofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
3D Motion
Description
Lower limb kinetics and kinematics will be calculated with inverse dynamics from 3D motion capture.
Time Frame
8-16 weeks
Title
Rate / Incidence of Knee Injury
Description
Knee injuries will be reported via coach, athletic trainer, or medical staff
Time Frame
8-16 weeks
Secondary Outcome Measure Information:
Title
Landing force
Description
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.
Time Frame
8-16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clifton Haider, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
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AI Driven Biofeedback Wearable
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