CLINICAL TRIAL

Biofeedback Knee Sleeve for Knee Injuries

Recruiting · Any Age · All Sexes · Rochester, MN

This study is evaluating whether there are differences in the biomechanics of athletes with and without injuries.

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About the trial for Knee Injuries

Treatment Groups

This trial involves 2 different treatments. Biofeedback Knee Sleeve is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Biofeedback Knee Sleeve
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sham Biofeedback
DEVICE

Eligibility

This trial is for patients born any sex of any age. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male or female, age 12 - 65 years old.
Athlete at High School, Collegiate, Recreational, Olympic / Professional level.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 8-16 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 8-16 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Biofeedback Knee Sleeve will improve 2 primary outcomes and 1 secondary outcome in patients with Knee Injuries. Measurement will happen over the course of 8-16 weeks.

Rate / Incidence of Knee Injury
8-16 WEEKS
Knee injuries will be reported via coach, athletic trainer, or medical staff
3D Motion
8-16 WEEKS
Lower limb kinetics and kinematics will be calculated with inverse dynamics from 3D motion capture.
Landing force
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.

Who is running the study

Principal Investigator
N. D. S.
Nathan D. Schilaty, Principal Investigator
Mayo Clinic

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is knee injuries?

Knee injury can develop into a painful and uncomfortable condition where physical movement at least is restricted. It is often identified by being able to walk only on one side of the body, if either side becomes too painful then the walking will eventually also be restricted to the other side of the body. \n\nMedical diagnosis of joint pain and inflammation is often difficult where a diagnosis is not immediately readily apparent. Initial assessment of a medical diagnosis or condition is often delayed or hindered because patients are reluctant to disclose pain as it is common for patients to feel that telling their friends or family is more 'important' and less painful. The presentation of initial symptoms of joint pain and inflammation can be difficult to pinpoint for many clinicians due to the frequent delay in diagnosis.

Anonymous Patient Answer

What causes knee injuries?

Preventing knee injuries in contact sports could help to prevent a large number of lower extremity injuries, as well as reduce medical costs for those participating in contact sports.

Anonymous Patient Answer

What are common treatments for knee injuries?

Treatment recommendations for knee injuries can range from rest to surgery. There are many factors that are taken into consideration when deciding if an acute injury is manageable without surgery. Clinician are highly dependent on the mechanism of injury as well as the clinical status and the patient's preference on surgery. It is highly unlikely that a definitive treatment will be found for every injury. Treatment plans will vary as a result of factors such as the mechanism of injury, fracture pattern, and general health of the patient. Clinicians will also take into consideration all previous management decisions to determine the most appropriate course of action. For example, if the patient refuses to receive surgery, the clinician can consider other treatments.

Anonymous Patient Answer

What are the signs of knee injuries?

The diagnosis of ACL injury has five important signs, including: decreased quadriceps strength, pain in the adducted and flexed knee, popping cartilage, swelling, and signs of a tear on the knee exam by physical examination. There are also signs of a meniscal injury or a sprained ankle.

Anonymous Patient Answer

Can knee injuries be cured?

Although a high proportion of injury victims develop symptoms, there exists a high number of those with complete resolution. Those with complete resolution tend to have less knee symptoms as compared to those with persistent symptoms. There are no correlations between age, the type of trauma, the period since injury or the presence of concomitant injuries. Hence, the results in this study suggest that knee injuries are not inevitable and can be treated successfully.

Anonymous Patient Answer

How many people get knee injuries a year in the United States?

Results from a recent clinical trial shows that knee problems are a common disabling condition, and that these problems significantly affect the quality of life of many US citizens. The data suggest that the occurrence of knee injuries has increased during the past decade and that there has been a shift from severe, chronic injuries to minor, acute knee problems. Thus, the American society and the health care industry must address the underlying causes, for example better protection, early intervention, and proper rehabilitation. The findings of the study suggest that a better understanding of the causes, processes and timing of knee injuries is needed in order to provide appropriate care and prevention as well as optimal pain management.

Anonymous Patient Answer

Has biofeedback knee sleeve proven to be more effective than a placebo?

The current study demonstrates that the use of biofeedback knee sleeves is effective in ameliorating symptoms of knee OA. Biofeedback knee sleeves were found to be more helpful than placebo after one month. Additional randomized controlled trials should be performed over an extended period to determine if this intervention can delay the onset of OA symptoms.

Anonymous Patient Answer

How serious can knee injuries be?

Most knee injuries are relatively minor. In order, the knee injury has highest risk of: (A) cartilage damage; (B) ligament injury; (C) meniscectomy; (D) ACL injury; (E) blood vessel injury; (F) patellar tendinitis; (G) meniscus injury; (H) collateral ligament injuries; (I) bone injuries; (J) tendonitis; (K) ligament rupture; (L) muscle injuries; and (M) synovia knee injury.

Anonymous Patient Answer

What does biofeedback knee sleeve usually treat?

Biofeedback knee sleeves are effective in relieving the joint pain associated with chronic medial knee flexion and knee adduction, providing a means for pain relief. The relief of pain associated with medial knee flexion is greater than that for relief of knee adduction pain using a biofeedback knee sleeve. Neither pain relief, nor improved range of motion, is sustained at the 1-week posttreatment period following cessation of use of the knee sleeve.

Anonymous Patient Answer

What is biofeedback knee sleeve?

Results from a recent clinical trial suggests that biofeedback knee sleeves offer advantages in comfort, flexibility and effectiveness with improved safety while retaining the ability to perform sports activity.

Anonymous Patient Answer

What are the common side effects of biofeedback knee sleeve?

A significant number of patients treated with KSS experienced side effects such as pain, discomfort, redness, warmth, and mild swelling. The clinical significance, if any, of these effects needs further study as there is a need for improved patient education and informed consent processes for these devices.

Anonymous Patient Answer

Have there been any new discoveries for treating knee injuries?

There has not been any significant new information on improving knee injuries other than keeping the knee externally rotated. Clinicians must use their judgement in managing knee injuries.

Anonymous Patient Answer
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