33 Clinical Trials for Various Conditions
Primary Objective: To explore changes in shear wave elastography (SWE) and microvascular flow imaging (MFI) measurements from time of injury through the recovery phase of lower extremity musculoskeletal injuries to determine if a correlation exists with functional impairment. Secondary Objective: To develop a deep learning AI system for automated region of interest (ROI) determination for measurement of average SWE and MFI. Methodology: Eligible subjects with lower extremity injuries will undergo SWE and MFI measurements and complete the Lower Extremity Functional Scale questionnaire at each study visit. Clinical data related to the evaluation of the injury acquired during standard medical care of the injury will be collected from the patients' medical record such as CT or MRI scans, X-rays, physical exams and tests as well as laboratory measurements. Subjects will undergo serial SWE and MFI imaging throughout their rehabilitation episode of care to assess changes over time, status in rehabilitation and comparison to the contralateral extremity.
Lower Extremity Musculoskeletal Injury
The goal of this clinical trial is to test the effectiveness of the MAP for Coaches, a web-based Musculoskeletal Athletic injury Prevention training course, in youth sport coaches. The main question it aims to answer are: * Is the MAP for Coaches effective in increasing coaches' sport-specific knowledge of musculoskeletal injuries (types, incidence, risk factors, mechanisms, and best prevention practices, with focus on neuromuscular training warm-up exercise programs)? * Is the MAP for Coaches effective in increasing coaches' motivation (self-efficacy and intention) to use sport-specific neuromuscular training warm-up exercise programs? The additional questions it aims to answer are: * Are the effects of the MAP for Coaches sustained in the short- and long-term? * Is the MAP for Coaches effective in promoting the use of sport-specific neuromuscular training warm-up exercise programs in youth sport coaches? Regardless of group, participants will receive the MAP for Coaches eLearning training course; however, the participants allocated to the control group will have their post-test survey completed right after they review the sport-specific 2-page injury prevention e-book containing an overview of the MAP for Coaches training course, including an infographic summary (Summarized MAP for Coaches eLearning Training Course). The intervention group will complete the post-test survey after the full training including both the course summary and the detailed course modules (the full training). The investigators will compare the two groups to see if an exposure to the (Full) MAP for Coaches eLearning Training Course improves study outcomes compared with the control group.
Knowledge, Attitudes, Practice
The long-term goal of this research is to implement methods that healthcare providers can use across diverse clinical settings to (1) identify athletes at risk for (musculoskeletal) MSK injury when cleared to return to play (RTP) after a concussion and (2) develop practical ways to reduce MSK injury risk following concussion RTP. The rationale is that once post-concussion MSK injury risk factors are known and prevention strategies tested, concussion RTP protocols will evolve to include injury risk reduction programs.
Brain Concussion, Musculoskeletal Injury, Locomotion, Postural Balance
In recent years, media attention has focused on the long-term sequelae of repeated concussive episodes in professional athletes. The growing understanding of the damage done by what was once considered a "ding" during a game or match, and the neurologic consequences of "playing through" or returning to play too soon has led to additional interest in and concern for pediatric athletes (18 or under) who experience sports-related concussions during game or practice play. Because it has only been in recent years that the full scope of damage done by repeated concussive episodes has come to light, very little research has been done on treatment of concussion in either adults or children. Brain injuries in children can be especially problematic, as the brain may continue to develop until the child reaches the age of 24 or older, so concussion during this time of development may be particularly damaging. Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and algae. DHA is known to improve development of the eyes and brain in young children. It is thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally and causes very few harmful side effects, it may be a useful compound in the treatment of pediatric concussion. This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric population. The investigators' primary aim is to determine acceptability of randomization for this compound as well as rate of enrollment given our clinical population. The investigators' secondary aim is to examine preliminary outcomes. The investigators hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to play and a shorter time to resolve balance disturbance. These are good, albeit unvalidated, clinical indicators of concussive recovery.
Concussion, Mild Traumatic Brain Injury
Sports-related injuries are a serious concern for physically active children and adolescents. Previous research, including ours at Chicago public high schools, shows our neuromuscular training program, the Knee Injury Prevention Program (KIPP) reduces sports-related injuries in female athletes by up to 88%. However, KIPP is not well-studied in males or younger age groups. This project aims to determine KIPP's effect on sports-related injuries and physical fitness among 5th-8th grade students in Chicago public schools. The study will take place during the 2011-2013 school years. To measure KIPP's effect on sports injuries, we will recruit 5th-8th grade sports coaches and their athletes, randomize coaches by school into two groups, then train the intervention group to implement a 10-minute KIPP warm-up before practices and games. Control group will perform their usual warm-up. Research assistants will collect athlete participation and injury data from coaches weekly. To determine feasibility of KIPP in PE classes and measure its effect on fitness, we will recruit PE teachers to implement the warm-up in PE classes for a minimum of 10 weeks, and record students' presidential fitness test scores before and after the 10+ weeks. Results of this study will guide strategies for preventing sports-related injuries and improving physical fitness in 5th -8th graders.
Leg Injuries
The purpose of this study is to assess the reliability of outcomes collected using a speed and cognitive light training system. This study will also be used to understand the effects of brain training on athletic performance using the FITLIGHT System.
Athletic Injuries
The purpose of this study is to complete a neuromuscular performance assessment of high school athletes who are participating in school based pre-season strength and performance training program. The performance assessment will screen for existing muscle imbalances and strength deficits known to increase risk for sports injury, and provide a baseline performance measurement. Athletes will be measured before the start of the program and then again at the end of the pre-season training period to measure changes in motor coordination, muscle strength, and performance and injury risk category. Internal and external training load will be measured weekly during the training program to track intensity of the training program. In addition to the pre and post measurements, sports injury occurrence and time away from sports participation will be tracked throughout the sport season/school year to evaluate training program outcomes and accuracy of risk assessment.
Athletic Injuries
The purpose of this research project is to evaluate the effectiveness of an injury prevention intervention for collegiate soccer players.
Athletic Injuries
The purpose of this research is to: 1. determine the normal or existing dynamic biomechanics of college athletes and 2. test the effectiveness of osteopathic manipulative medicine in the treatment of athletic injuries. Motion capture using Vicon systems allows researchers to quantify characteristics of a body such as the range of motion of the hip or shoulder during an athletic technique such as kicking or shooting a basketball into the basket. The quantified information has been used before to better understand human mobility and performance. Osteopathic manipulative medicine (OMM) is manual medicine applied to joints, muscles, and connective tissue with a goal of improved body functions. Research demonstrating effectiveness of OMM on the musculoskeletal and associated connective tissue systems health includes, among others, prospective clinical trials of OMM for treatment of neck pain, low back pain, and acute first- and second-degree ankle sprains.
Athletic Injuries
The primary purpose of this study is to determine whether Flector Patch is safe for use in children. The secondary purpose is to assess blood levels of diclofenac, the active ingredient in Flector Patch.
Athletic Injuries
The overall goal of this project is to reduce the risk for anterior cruciate ligament injuries by designing a targeted intervention that will alter the known kinematic and kinetic risk factors associated with ACL injuries.
Athletic Injuries, Sprains and Strains, Wounds and Injuries, Knee Injuries
The purpose of this study is to examine the effect of intermittent fasting on the acute neural responses to subconcussive head impacts. The study is designed to identify the effects of 20 controlled soccer headings in college-aged soccer players in one of four groups (fasted, pre-fasted, post-fasted, or control) through the use of neural-injury blood biomarkers, magnetic resonance spectroscopy, functional, and diffusion MRI, and ocular-motor function across 4 acute time points. The central hypothesis is that the neuronal structural, physiological, and functional impairments from the subconussive head impacts will be lessened by intermittent fasting either before or after the soccer headings. The neural-injury blood biomarkers neurofilament light (NfL), glial fibrillary acidic protein (GFAP), Ubiquitin C-Terminal Hydrolase L1 (UCH-L1), and Tau will be measured in serum, with the hypothesis that fasting prior to the 20 soccer headings will result in a decreased heightened response compared to the post-heading fasted group and the controls. It is also hypothesized that repetitive subconcussive head impacts will impair neurocognitive function, as measured by regional changes in fMRI activation during a working memory task in the fasted groups. Twenty headings will significantly alter fMRI activation in the fasted groups from baseline. This impairment will not be observed in the control group. White matter microstructure will be measured by diffusion imaging metrics, with the hypothesis that 20 soccer headings will significantly disrupt microstructure in the fasted groups compared to baseline, but not in the control group. The study will also assess neuro-opthalmologic function as measured by the King-Devick test (KDT) and oculomotor function as measured by near-point-of-convergence (NPC) in response to subconcussive head impacts. The hypothesis is that NPC performance will be significantly impaired for longer than 24 hours in all the groups, but this impairment will be greater in the control group, and that the learning curve and expected improvement of KDT will be significantly blunted in both groups, with a display worsening in the control group.
Sports Injury, Intermittent Fasting
The overall purpose of this study is to quantify the effect and retention of one-week training of falling techniques on landing biomechanics associated with anterior cruciate ligament (ACL) loading compared to soft-landing techniques in young recreational athletes. The secondary purpose is to assess the safety of the training program. Aim 1: To quantify the effect of one-week training of falling techniques on landing biomechanics during forward, lateral, vertical, and diagonal landings compared to soft-landing techniques. We hypothesize that falling techniques will result in increased knee flexion angles and decreased landing forces, knee abduction and internal rotation angles, and knee moments for all landing directions compared to soft-landing techniques immediately after the training. Aim 2: To assess the retention effects of the falling techniques on landing biomechanics compared to soft landings. We hypothesize that the effects of falling techniques on ACL loading variables will be more highly retained compared to soft-landing techniques two weeks after the training. Aim 3: To identify the safety of the training program. We hypothesize that participants can complete the training without suffering minor, moderate, or major injuries, while occasional minor bruises might be observed.
Sports Injury, Orthopedic Disorder, Knee Injuries, Anterior Cruciate Ligament Injuries
Competitive sport increases risk for musculoskeletal injury (e.g., traumatic knee injury) and may position former athletes for early onset of chronic diseases, chronic pain, poor health-related quality of life, and disability. Quantifying function in former athletes with and without a prior injury and non-athlete controls is critical to understanding long-term health trajectories in athletes and informing potential interventional studies. One modifiable factor that may be associated with long-term health in athletes is physical activity patterns. The purpose of this study is to evaluate strength, function, physical activity, dietary patterns, and cardiometabolic health among current and former competitive athletes and in nonathlete controls to evaluate the impact of prior knee injury and sedentary behavior as two potential determinants of later poor health and reduced function.
Aging, Athletic Injuries, Physical Inactivity, Knee Injuries and Disorders
A qualitative study, as a follow-up to an earlier study, that provides an opportunity to develop a deeper understanding of the injured cyclist's behavior related to seeking medical attention and endurance of pain. This study includes 10 club-level cyclists who have an injury and either have or have not sought medical attention.
Pain, Sport Injury, Athletic Injuries
The purpose of this study is to determine the neurologic and cognitive effects of playing tackle football in grade school and high school. During contact practices and games, players wear a football helmet containing an impact sensor. Before and after each season, players complete neurological testing to measure several different aspects of brain function. Two groups of football players will be in the study: 5th and 6th grade tackle football players from the Brighton Bulldogs Football and Cheer league (about 70 players). Varsity football players from Brighton High School (about 70 players per year). The study begins in July 2016 and will continue for 4 years (through the winter of 2020).
Concussion, Brain, Athletic Injuries
Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT scores and MRI findings between the two groups to see if there is a statistical difference in reduction of injury and to establish what the baseline level of MRI findings related to injury from high school football is as well as what the baseline level of injury is prior to the start of the season.
Brain Concussion, Brain Injuries, Diffuse Axonal Injury, Athletic Injuries, Injury, Brain, Traumatic
The anterior cruciate ligament (ACL) is located inside the knee joint and provides stability to the knee. ACL injuries occur more frequently in women than men; the reason for this is unknown. The purpose of this study is to determine gender-specific anatomical, hormonal, and demographic risk factors for ACL injury. This observational cohort study will only enroll incoming cadets at the U.S. Naval, Air Force, or Military Academies. Study hypothesis: Human movement factors, including key kinetics and kinematics of the knee during a jump-landing task, are associated with the rate of ACL injury.
Knee Injuries, Athletic Injuries
The goal of this randomized clinical trial is to determine if administration of Exparel via local infiltration for medial patellofemoral ligament (MPFL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are: * Does Exparel significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively? * Does Exparel significantly decrease narcotic use (number of pills taken) up to one week postoperatively? Researchers will compare the pain outcomes and narcotic use of patients who receive Exparel and Marcaine via local infiltration to those of patients who receive only Marcaine via local infiltration for their MPFL reconstruction surgery. The goal is to understand if there is a significant difference in patient pain outcomes and narcotic use outside the first 24 hours postoperatively. Participants will: * receive either Exparel + Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery * receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction * receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery at postoperative day 1
Medial Patellofemoral Ligament (MPFL) Reconstruction, Sports Injuries in Children, Analgesia, Pain, Postoperative
The goal of this randomized clinical trial is to determine if single-shot ropivacaine peripheral nerve blocks (PNB - perineural injections) for anterior cruciate ligament (ACL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are: * Does ropivacaine significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively? * Does ropivacaine significantly decrease narcotic use (number of pills taken) up to one week postoperatively? Researchers will compare the pain outcomes and narcotic use of participants who receive a single-shot ropivacaine peripheral nerve block to those of participants who do not receive a single-shot ropivacaine peripheral nerve block for their ACL reconstruction surgery. The goal is to understand if there is a significant difference in participant pain outcomes and narcotic use outside the first 24 hours postoperatively. Participants will: * receive either a single-shot ropivacaine peripheral nerve block intraoperatively or no peripheral nerve block during their ACL Quadriceps tendon graft or bone patellar tendon bone graft reconstruction surgery. * receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction * receive and complete secondary outcome measures of functional and psychological outcomes regarding their ACL reconstruction surgery at postoperative day 1
Anterior Cruciate Ligament (ACL) Tear, Sports Injuries in Children, Analgesia, Pain, Postoperative
This study will compare patient reported outcomes (PROs) and patient satisfaction scores of patients seen at virtual phone visits with patients seen at in-person visits for post-operative follow up at 6 weeks, 12 weeks, and 6 months at a sports medicine clinic. This study will determine if there is a difference in PROs and satisfaction scores between these two groups of patients. The investigators hypothesize patients who are seen during a virtual phone visit will report different PRO and patient satisfaction scores compared to patients who are seen during an in-person visit for post-operative follow-up at 6 weeks, 12 weeks, and 6-months.
Patient Satisfaction, Sports Injury, Surgery, Orthopedic Disorder
This study is comparing total intravenous anesthesia with propofol with a regional nerve block against general anesthesia with a regional nerve block on the primary endpoint of time to meet discharge criteria.
Rotator Cuff Tears, Rotator Cuff Injuries, Orthopedic Disorder, Sports Injury, Anesthesia
A study is proposed to test whether adding additional referees to youth soccer matches may reduce the risk of injury to the children playing soccer. Publicly-open youth soccer games will be randomly assigned to have either one or three referees and videotaped. The videotaped games will then be watched to record risk-taking behavior by players, referee decisions, and other factors relevant to potential injury.
Injuries, Sports Injury, Sports Injuries in Children
Adolescent brains undergo rapid and significant changes in structural architecture and functional organization during development. A concussive injury during this developmental period can have substantial physiological and cognitive ramifications. If not adequately managed, adolescent concussions can have profound long-term effects. The purpose of this study is to determine whether ketone supplementation after a concussion will reduce long-term consequences and improve short-term functional status and outcomes in adolescents who have suffered a concussion.
Concussion, Mild, Concussion, Severe, Concussion, Brain, Concussive Injury, Sport Injury, Sports Injuries in Children
This three-year study will determine the effectiveness of a helmetless tackling training intervention to decrease head impact exposure in Hawaiian high school football players.
Head Trauma, Cognitive Change, Confidence, Self, Sports Injuries in Children
The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions. The study is prospective, with outcome measures being obtained at numerous time points after the regenerative procedure.
Osteoarthritis, Tendinitis, Sports Injury, Degenerative Disc Disease, Degenerative Arthritis, Ligament Injury, Neuropathy, Pelvic Pain
Sports-related concussions are common in adolescent-athletes. Prolonged recovery after concussion or post-concussion syndrome (PCS) is a public health problem. This project will determine the effectiveness of an aerobic exercise program for management of PCS and it will evaluate the influence of exercise on biologic correlates of PCS.
Concussion, Post-concussion Syndrome, Sports Injury
The purpose of this study is to study the biomarkers in subjects before and after sports-induced traumatic brain injury. The assay will be studied in a sample population of subjects over the age of 18 participating in college sports.
Traumatic Brain Injury, Sports Concussion, Sports Injury
The goal is to determine if standard therapy including joint mobilizations of the ankle performed 3 times per week for 2 weeks will increase self-reported function and decrease pain in patients with mild lateral ankle sprains.
Ankle Sprain
This study aims to establish and validate age-based head kinematics, force-strain models and brain injury probability maps from sensor worn data during soccer heading tasks. 40 youth soccer players will be recruited from the Madison, WI area and can expect to be on study for 2 months.
Brain Injuries