Knee InjuriesNCT04921410
AI Driven Biofeedback Wearable
A study testing Biofeedback Knee Sleeve in people with Knee Injuries, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Biofeedback Knee Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female, age 12 - 65 years old.
- Athlete at High School, Collegiate, Recreational, Olympic / Professional level.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Knee Injuries
- Being tested
- Biofeedback Knee Sleeve, Sham Biofeedback
- Keywords
- injury, prevention, biofeedback, knee, wearable, rehabilitation
- Medical subject headings
- Knee Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback Knee SleeveDevice
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 BiofeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D Motion
Lower limb kinetics and kinematics will be calculated with inverse dynamics from 3D motion capture.
Measured: 8-16 weeks
Rate / Incidence of Knee Injury
Knee injuries will be reported via coach, athletic trainer, or medical staff
Measured: 8-16 weeks
Secondary outcomes (1)
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.
Measured: 8-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start20 Jul 2021
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clifton R. Haider, Mayo Clinic
- Investigators
- Clifton Haider, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921410
- Sponsor's protocol ID
- 21-004218
- Status last verified
- Feb 2023
- First submitted
- 1 Jun 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificially Intelligent Biofeedback Sleeve for Prevention and Rehabilitation of Traumatic Knee Injury
- ClinicalTrials.gov ID
- NCT04921410
- Acronym / sponsor ID
- 21-004218
- Conditions
- Knee Injuries
- Keywords
- injury, prevention, biofeedback, knee, wearable, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Sleeve Effects on Preventive Biomechanics | Experimental | Device: Biofeedback Knee SleeveBiofeedback 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. |
| Sham Biofeedback | Sham comparator | Device: Sham BiofeedbackBiofeedback 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. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, age 12 - 65 years old.
- Athlete at High School, Collegiate, Recreational, Olympic / Professional level.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback Knee SleeveThe 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. | Device | Biofeedback Sleeve Effects on Preventive Biomechanics |
| Sham BiofeedbackThe 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. | Device | Sham Biofeedback |
Primary outcome
3D Motion
Time frame: 8-16 weeks
Lower limb kinetics and kinematics will be calculated with inverse dynamics from 3D motion capture.
Rate / Incidence of Knee Injury
Time frame: 8-16 weeks
Knee injuries will be reported via coach, athletic trainer, or medical staff
1 secondary outcome
Landing force
Time frame: 8-16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clifton Haider, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback Knee Sleeve in people with Knee Injuries, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D Motion (time frame: 8-16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.