16 Clinical Trials for Various Conditions
The purpose of this proposed study is to investigate both the acute and chronic response of frontal plane knee moment after gait retraining and to assess the effects on the biomechanics of the contralateral side. Fifty-one patients diagnosed with tibiofemoral joint osteoarthritis (TFJ OA) will be recruited to participate in the proposed study. Participants will complete baseline trials to assess gait kinematic and kinetic parameters. Following baseline, each participant will perform six conditions of the foot progression gait or three conditions of the trunk lean gait modifications to determine which strategy is most effective in reducing frontal plane knee moment. Participants will then be randomized to either the control or experimental group based on their identified preferred strategy. Participants will complete eight gait retraining sessions using patient-specific gait modifications (tailored foot progression and tailored lateral trunk lean), or normal gait (control) during the training period. A fading feedback design will be implemented. Real-time haptic biofeedback will be provided on every step during the first two weeks and reduced by 25% every subsequent two weeks. No feedback will be provided during baseline and at testing sessions. Measures of pain and function will also be collected at all testing sessions. Variables of interest include ankle, knee, hip sagittal and frontal plane moments. In addition, sagittal and frontal plane impulse will also be assessed. Descriptive statistics will be calculated for foot progression angle, trunk lean angle, frontal and sagittal plane hip, knee, and ankle angles as well as moments. Descriptive statistics for frontal plane knee impulse will also be calculated. A multivariate analysis of variance (MANOVA) will be conducted to compare frontal plane knee moment, frontal plane knee impulse and the absolute sagittal plane moment will be compared across three groups at four different time points. Repeated measures analysis of variance (ANOVA) will be conducted to compare both sagittal and frontal plane joint biomechanics for the contralateral limb. The p-value will be set at .05.
The purpose of this study is to quantify changes in ankle and knee motion and force resulting from five progressive modifications to the anterior-posterior trim lines of thermoformed ankle-foot orthoses (AFO). It is hypothesized that the AFO with the most anterior trim line will prevent the most plantar flexion during loading response (the first 10% of the gait cycle)and prevent the most dorsiflexion at terminal stance (from 30 to 50% of the gait cycle) as compared to the non-device condition. This will be evidenced by the sagittal plane ankle motion and ground reaction force magnitude and location during loading response and terminal stance. Additionally, the angular velocity of knee flexion will increase during these same periods. By contrast, as the trim lines are moved more posterior this will result in lowering the effective stiffness of the device which will result in progressive increases in dorsiflexion and allow increasing amounts of knee flexion during terminal stance.
The purpose of this study is to determine differences in lower extremity landing biomechanics and real-world physical activity between individuals with patellar tendinopathy compared to individuals without patellar tendinopathy,and to determine the acute effects of an isometric loading intervention on lower extremity landing biomechanics in individuals with patellar tendinopathy.
The goal of this study is to understand the impact of wearing shoes with a compliant, energy absorbing midsole material, outside of athletic training sessions on the mechanics of movement, performance, and perceived joint pain and stiffness. Advances in material science have led to a wider range of cushioning system material properties and mid and outsole geometries in footwear. While there are many marketing claims about the potential health benefits of this new class of footwear these have not yet been investigated in well-designed scientific studies. It is hypothesized that the intervention shoe as compared to the control will reduce self-reported joint pain and stiffness, improve ankle plantarflexion function and increase intersegmental foot motion during walking.
When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available. While these conventional prosthetic feet primarily function in the sagittal plane, the intact foot and ankle comprise a complex set of joints that allow rotation in multiple planes of motion. Some of these motions are coupled, meaning rotation in one plane induces motion in another. One such coupling is between the sagittal and transverse planes. For every step, plantar- and dorsi-flexion motion in the sagittal plane is coupled with external and internal rotation of the shank relative to the foot in the transverse plane. There is no prosthetic foot available for prescription that mimics this natural coupling. To investigate the need for this coupling, the investigators have built a torsionally adaptive prosthesis where the coupling ratio between the transverse- and sagittal-planes can be independently controlled with a motor. This research has one specific aim: to identify the optimal coupling ratio between transverse- and sagittal-plane motions using a novel, torsionally adaptive prosthesis for individuals with lower limb amputation. The investigators will conduct a human subject experiment wearing the motor-driven and computer controlled torsionally adaptive prosthesis. Individuals with lower limb amputation will be asked to walk in a straight line and in both directions around a circle while the coupling ratio between transverse- and sagittal-plane motions is varied between trials. Participants will be blinded to the coupling ratio. The investigators hypothesize that: (1) a coupling ratio exists that minimizes undesirable transverse-plane socket torque and (2) there will be a coupling ratio that individuals with lower limb amputation prefer.
The purpose of this study was to determine the effectiveness of two types of in-shoe custom made orthotics in altering the motion of the foot and muscle activity of select muscles of the lower leg in individuals experiencing lower extremity symptoms of a non traumatic origin. We hypothesized that orthotics would decrease the extent of motion of the during walking and running when compared to a barefoot condition. The investigators further hypothesized that orthotics would decrease the amount of muscle activity seen during walking and running when compared to barefoot walking.
The purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy during stepping tasks.
The primary purpose of this research study is to determine if the stiffness of a commercially available ankle foot orthosis (Malleo-Lok, Bio-Mechanical Composites, Des Moines IA) impacts gait biomechanics and overall joint level stiffness. Previously published research suggests that AFO stiffness can affect gait biomechanics and patient preference. However, previous studies have focused on traditional posterior strut devices with the strut aligned in the frontal plane to allow sagittal plane deflection. The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane. The proposed study will provide insight that can be used by certified prosthetists orthotists (CPOs), physical therapists, and physicians to select the device that bests meets their patients' needs.
Intermittent claudication afflicts 5% of the US population older than 55 years of age and develops along with hardening of the arteries of the legs. Claudicating patients limp and can only walk very short distances because their legs hurt. This protocol evaluates the mechanisms that may produce the leg dysfunction of claudication and its successful completion can ultimately produce significant new diagnostic and treatment strategies for the care of claudicating patients.
The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.
In this pilot study the investigators are testing whether an injury prevention program will help improve quality of movement and decrease number of injuries in collegiate women's lacrosse athletes. The primary purpose is to determine whether an injury prevention program including individualized movement instruction along with an educational program is better than an educational program alone for improving movements that can increase risk of injury and decreasing number of injuries. The investigators will recruit women's lacrosse athletes from the San Diego State University women's lacrosse team. Enrolled participants will be divided up into two groups of 10 individuals. Both groups will participate in an injury prevention educational program including a lecture component with pictures and videos, and a practice component in which athletes will be provided with group instruction on how to perform the activities and then will have an opportunity to practice all activities. In addition to the educational program, athletes in the individualized movement instruction group will be provided individualized feedback on their movements when performing activities from the injury prevention program during 3 sessions throughout the season. The primary outcomes that will be evaluated include lower body movement during a jumping and balance task as measured using a 3D motion capture system. The investigators hypothesize that participants who receive the individualized feedback in addition to the education program will display greater improvements in movements that increase injury risk when compare to the education only intervention group.
The goal of this clinical trial is to identify prosthesis stiffness that optimizes balance control in individuals with below knee amputations. The main question this clinical trial will answer is: • Is there an optimal stiffness that improves balance control for specific ambulatory activities and users? Participants will wear a novel prosthesis assembled with three prosthetic feet with a range of stiffness levels: each individual's clinically-prescribed foot stiffness and ± two stiffness categories. While wearing the study prostheses, participants will perform nine ambulatory activities of daily living (walking at different speeds, turning, ramp ascent/descent, while carrying a load, and while walking on uneven terrain).
Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported pain, and comfort.
The purpose of this research is to design a high-performance, customized, and rapidly- manufacturable passive prosthetic foot for use in the United States. We are currently testing an early stage prototype and would like user input before pursuing additional clinical testing. Participants will be asked about their current prosthesis type and use, amputation side and cause, and activity level. We will take measurements of height, weight, and length of the participant's residual limb. The participant will be asked to walk in several prosthetic foot conditions in multiple walking activities, and the visit should last approximately four hours. For each prosthetic foot, a trained prosthetist will fit the foot (either a prototype foot or a commercially available K3/K4 foot) to the prosthesis. The patient will then walk around the room until they feel comfortable. They may initially walk using a gait belt or between parallel bars based on comfort level and an evaluation by the prosthetist. Once they feel comfortable walking on level ground at a normal speed and the prosthetist feels that they will be safe performing more challenging walking activities, the participant will perform different walking activities (such as walking on flat ground at different speeds, walking up/down ramps, and walking up/down stairs). They will then be asked to tell the investigator what they like and dislike about the prosthetic foot.
Carbon fiber custom dynamic orthoses (CDOs) consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. The important role of the proximal cuff has not been examined. The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics.
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.