181 Clinical Trials for Various Conditions
Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. The third and final aim is to determine whether a brief trial of commercial prosthetic feet can predict longer-term stability and balance-confidence outcomes in Veterans with TTA. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements in Veterans and Service members with TTA. Up to 50 participants will be enrolled at each of the two study sites VA Puget Sound and VA Minneapolis. Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the 'high' or 'low' mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests on difference surfaces in the laboratory (cross-slopes, inclines, even, and uneven ground). During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if visit 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately one week. At visit 4 participants will be fit with the next actual foot and repeat the 1 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6.
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot. To accomplish this, the study will use a combination of laboratory motion analysis, functional tests, and community mobility trials where participants complete questionnaires and interviews about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot. Individuals with amputations that participate in the (optional) motion analysis sub-study at the University of Washington will complete forward walking, side-step, and across river rock with usual foot (session 1), and also with the investigational foot locked and unlocked (session 2) after an accommodation period of between 1-4 weeks. The participants will rate their experiences using socket comfort score and the socket pressure score. Control participants recruited at the University of Washington to provide information about performance for people without amputation will go through the consenting process, then will be asked to complete forward walking, Figure-of-8 Walk Test, Narrowing Beam Walking Test, side-step, and walking across river rock surface. These tests will be conducted at a single session.
Objective/Hypotheses and Specific Aims: The primary aim of this proposal is to determine whether a PFE can be used to predict foot preference and mobility outcomes with corresponding commercial prosthetic feet in people with a unilateral transtibial amputation (TTA). Secondarily, the investigators aim to determine whether a brief trial of commercial prosthetic feet would be able to similarly predict longer-term foot preference and mobility outcomes with those feet. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements. Participants with TTA will be enrolled at each of the three study sites: two VA sites (Puget Sound and Minneapolis), and one Department of Defense site (Center for the Intrepid). Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the high or low mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests in the laboratory. During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if Day 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately two weeks. At visit 4 participants will be fit with the next actual foot and repeat the 2 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6. Participants' preference, satisfaction and perceived mobility, and functional mobility will be measured and compared across all foot conditions (emulated and actual). After participants complete the procedures detailed above, they may be eligible to be invited to participate in follow-up phone interviews. A subset of participants may also be invited to participate in follow-up biomechanical data collection comparing the PFE foot conditions to the respective actual prosthetic feet during walking. Additionally, a subset of participants may also be invited to participate in follow-up data collection comparing prosthetic foot conditions of different stiffness categories.
The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.
Upper limb amputation is a devastating injury that leaves many thousands of typically young and active individuals in the US to rely on artificial arms and hands to help restore their lost function. The investigators research is focused on helping these individuals to feel where their prosthetic limbs are moving without having to look at them by developing devices and approaches to provide sensory feedback of limb movement through the nerves that once served the missing limb.
The investigators objective is to run human clinical trials in which brain activity recorded through a "brain-chip" implanted in the human brain can be used to provide novel communication capabilities to severely paralyzed individuals by allowing direct brain-control of a computer interface. A prospective, longitudinal, single-arm early feasibility study will be used to examine the safety and effectiveness of using a neural communication system to control a simple computer interface and a tablet computer. Initial brain control training will occur in simplified computer environments, however, the ultimate objective of the clinical trial is to allow the human patient autonomous control over the Google Android tablet operating system. Tablet computers offer a balance of ease of use and functionality that should facilitate fusion with the BMI. The tablet interface could potentially allow the patient population to make a phone call, manage personal finances, watch movies, paint pictures, play videogames, program applications, and interact with a variety of "smart" devices such as televisions, kitchen appliances, and perhaps in time, devices such as robotic limbs and smart cars. Brain control of tablet computers has the potential to greatly improve the quality of life of severely paralyzed individuals. Five subjects will be enrolled, each implanted with the NCS for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.
This protocol will evaluate the sensitivity and specificity of \[124I\]FIAU as a diagnostic imaging agent for the detection of prosthetic joint infections in patients.
This study centers around the imaging of internal structures of residual limb by means of modern radiographic imaging techniques (Dynamic Radiography-DRSA). The purpose of our research is to further study the behavior of bones and soft tissue of the socket-stump interface during dynamic tasks such as walking or brisk walking. In the long term this research could prove a basis for improvements in the general design of sockets for the new generation of prosthetic devices.
The purpose of this clinical trial is to determine if the experimental Tensegrity prosthetic foot offers a reduction of the amount of oxygen used while walking, if stability is improved over current prosthetic feet, and whether the experimental device actually increases activity in amputees.
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are: * Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)? * Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs? Participants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.
The purpose of this study is to determine whether probiotics in addition to standard of care (SOC) can improve immunological markers following treatment for prosthetic joint infection (PJI). The study aims to determine whether probiotics in addition to SOC decrease immunological markers following treatment for PJI, improve medical and surgical complications and mortality in patients with PJI, and lead to improved gastrointestinal (GI)-specific patient reported outcomes measures (PROMs) in patients with PJI.
The goal of clinical trial is to assess an integrated, patient-centered strategy combining user preference-based prosthetic foot prescription and subsequent targeted physical therapy to maximize satisfaction and mobility outcomes for Veterans and others with lower limb loss. The main aims it will address are: * Assess the effect of prosthetic foot selection based on experiential preference as determined using a variable stiffness foot on mobility and satisfaction * Assess the effect of a targeted physical therapy intervention following preference-based foot selection on mobility, balance, and satisfaction? Participants will walk with an emulator prosthetic foot to experience three different conditions that emulate different commercial feet to determine their most- and least-preferred foot. Participants' satisfaction, perceived mobility, and functional mobility will be measured and compared between their most- and least-preferred feet using the corresponding commercial feet. Participants will then be randomly assigned to receive either the standard-of-care (control group) or personalized physical therapy intervention for eight weeks using that preferred prosthetic foot. Participants' satisfaction, mobility, and balance will be measured pre- and post-intervention.
The goal of this proposed project is to evaluate the effectiveness of our novel wireless electrode system, which the investigators refer to as the ASTERISK system, on transradial prosthesis users. There are numerous benefits to the upper limb prosthesis community being able to utilize wireless electrodes. These benefits include allowing for the use of a prosthetics liner to assist with fit and comfort, easier implementation of EMG-controlled prosthesis for individuals with osseointegration, and additional EMG electrode location options if the muscle activity captured within the prosthetic socket does not provide reliable prosthesis control. The investigators intend to use this data to develop the ASTERISK wireless electrode system into a commercial product. The findings will also be shared with the research community to help drive the design of future devices.
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).
The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic accessibility crisis. This is a single-site, Phase I, Clinical Research Study to test the effectiveness and safety of the LIMBER UniLeg. One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).
Prosthetic joint infection (PJI) is one of the most devastating complications following total joint arthroplasty (TJA) of the hip and knee. Standard of care (SOC) treatment includes surgery and antimicrobials. Morbidity and mortality remain high despite contemporary treatments. The human body is colonized by billions of organisms, collectively, the microbiome, which is central to healthy immune function. Microbiome disruption, dysbiosis, can impair the immune response to infection. Despite recent evidence that suggests dysbiosis may be implicated in PJI, the role of probiotics in the treatment of PJI is unknown. Perioperative probiotics have been demonstrated to be safe and effective for infection prevention in abdominal surgery. The investigators hypothesize that perioperative probiotics will reduce re-infection in patients treated for PJI. A multi-centered, randomized controlled trial (RCT) at two academic, tertiary care centers will be conducted to determine the impact of probiotics on recurrent infection following treatment for PJI. Controls will receive SOC; study patients will receive a probiotic, started shortly after the initiation of and for the duration of their antibiotic therapy + 7 days, in addition to SOC. Primary outcome is re-operation for recurrent infection within 1 year.
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making pathogens substantially more susceptible to established antibiotic treatment regimens. This Phase 2 study is designed to assess efficacy and safety of TRL1068 in combination with a DAIR (debridement, antibiotics, and implant retention) procedure for chronic prosthetic joint infections of the knee and hip, specifically, eliminating the need for the standard of care 2-stage exchange surgery, so that the original prosthesis can be retained.
The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.
The goal of this study is to utilize the Gaze and Movement Assessment (GaMA) metric to assess the effect of different prosthetic components on compensatory movements used to complete activities of daily living.
The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.
A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.
The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.
The overall goal of this project is to model human joint biomechanics over continuously-varying locomotion to enable adaptive control of powered above-knee prostheses. The central hypothesis of this project is that variable joint impedance can be parameterized by a continuous model based on measurable quantities called phase and task variables. This project will use machine learning to identify variable impedance functions from able-bodied data including joint perturbation responses across the phase/task space to bias the solution toward biological values.
Patients presenting with prosthetic joint infections of a total knee replacement who are treated with an antibiotic spacer will be observed prospectively for their response to treatment and antibiotic elution profiles will be measured post-operatively utilizing mass spectrometry from synovial fluid acquired as part of standard of care in the management of prosthetic joint infection. Secondary outcomes including post-operative complications, re-operation rates, and re-admission rates will also be compared.
This research and development will improve upon and investigate the potential validity of an innovative new transradial socket and harness design (the KSH system) that offers an alternative to standard hard sockets and rubber liners with a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The project consists of designing, custom fitting and evaluating the function and comfort of the this new novel system. The study will take place in 3 phases; Phase 1, five experienced Veterans with transradial arm amputations will be recruited to provide guidance and to assist with the design and development. Experienced end-user Veterans and Clinical staff will work together to assist with design, develop the fitting process and working with engineers on the design of a completely digital fitting device for measuring the residual limb and locating bony prominences of the limb to inform the socket design. Phase 2, testing and assessment, the design and process validation will take place with the five Veteran upper transradial arm amputees Phase 3, an additional 20 Veterans with transradial arm amputations will be recruited and fit with the KSH system and undergo a series of evaluative tests. Veterans will perform a series of static and dynamic tasks to evaluate function, comfort and load bearing failure. The primary goal of this study is to improve upon the current preliminary prototype and to test it with a broader population of potential users to help advance the engineering and design, and to learn the potential to fit a range of Veterans with transradial amputations.
In summary, subjects will be asked to wear a number of sensors and use different ankle-foot prostheses in place of their customary prosthesis. Data will be collected from the wearable sensors, VICON motion capture system, video cameras, and force sensors in the ground as they walk on level-ground, on a treadmill, and on stairs. The controller of any powered prosthesis will be electronically adjusted between trials or while the subject walks to determine how their gait changes in response to these changes. Trials will also be conducted with a standard passive prosthesis that would be prescribed for a person of similar height and weight.
When the prosthetic socket of a Veteran with a lower limb amputation no longer fits or is damaged beyond repair, a new prosthetic socket is warranted. The provision of a new socket requires multiple clinical visits which can place a high travel burden and potential pandemic exposure stress on Veterans who live in rural communities far from VA Medical Centers or alternative prosthetic clinics. This research seeks to determine if one of the in-person visits traditionally needed to obtain a well-fitting prosthesis can be performed remotely with the assistance of a helper. The investigators seek to discover if an untrained individual (a helper) can wield inexpensive, easy to use, digital technology to capture the shape of a residual limb to see if it can be used to fabricate a prosthetic socket that fits at least as well as one fabricated by a prosthetist using traditional, hand casting methods in the clinic. The expected result of this research is an evidence-based prosthetic fabrication process that reduces Veteran travel burden while providing a prosthesis that fits at least as well as the current standard-of-care. The upshot is a clear improvement in prosthetic provision for Veterans, particularly for those who live in rural communities. To make this determination, the investigators will perform a between-subject experiment with two specific aims. To determine differences in goodness of fit between the two study sockets, the investigators will use both patient reported outcomes, and measurements of the pressure applied to the distal end of the residual limb. Specific Aim 1: Determine if patient reported outcomes, by subjects wearing a prosthetic socket whose shape was captured with study helper assistance, are at least as good as those reported by subjects wearing a socket whose shape was captured by a prosthetist. The investigators propose to recruit Veterans with a below knee amputation and their study helpers to participate in a human subject experiment. Participants will be randomly assigned and fit with either a prosthesis made with study helper assistance and digital methods, or one made wholly by a prosthetist using traditional methods. Patient reported outcome metrics will be collected while the subject is still wearing their as-prescribed socket at the beginning of the study (baseline), and again after wearing the study prosthesis for two weeks. Specific Aim 2: Determine if distal end residual limb pressure, measured from a group of individuals fit with a prosthetic socket whose shape was captured with study helper assistance using digital methods, are no worse than those measured from a group of individuals fit with a prosthetic socket whose shape was captured by a prosthetist using traditional methods. Concurrent with the human subject procedures briefly described above, the investigators propose to fabricate duplicates (copies) of the two prosthetic sockets used by each subject in Specific Aim 1. A novel sensor will be embedded in these duplicate sockets which can measure the pressure applied to the distal end of the residual limb. Measurements of distal end residual limb pressure while standing and walking for both the as-prescribed and study sockets will be collected at the beginning of the study (baseline), and again after two weeks. The data from the investigators' experiments will be used to determine if residual limb shape capture by a helper using digital technologies can be used to make prosthetic sockets that fit at least as well as those made by a prosthetist using traditional, hand casting techniques. One third of all Veterans live in rural communities far from VA Medical Centers. When Veterans with a lower limb amputation need a new prosthetic socket, attending in-person clinical visits can be a challenge. If the hypotheses are supported, this research will provide evidence to support the use of digital technology as part of clinical practice, enabling a remote, study helper enabled alternative to one of the in-person clinical visits needed to fabricate a well-fitting prosthesis.