15 Clinical Trials for Various Conditions
The purpose of this prospective randomized crossover study is to evaluate the effectiveness of a new pain relief footwear, Orthofeet, in reducing foot pain and improving daily physical activity. The investigators hypothesize that wearing Orthofeet shoes will lead to a reduction in foot pain, resulting in increased daily physical activity, objectively measured using validated wearable devices.
The objective of this proposal is to determine the effects of footwear stiffness on a large cohort of high school football players during a football season. The investigators expect that functional athlete groups will be developed, based on subject specific assessments (biomechanical, morphological, performance, comfort), and lead to important translational findings that may impact footwear modification and recommendation to a population of American football players. Two standard cleats will be randomized and provided during a season of high school football. Ratings of comfort, performance, and injury will be collected throughout the season.
Veterans with leg amputations have limited footwear options because their artificial feet do not change shapes for different shoes. Studies have shown that women with amputations receive more frequent prosthetics care than men, but are less satisfied with the fit, comfort, and appearance of their prostheses. The investigators' previous research indicates that women Veterans would like to be able to wear a broader variety of footwear, and those who perceive more footwear limitations tend to have poorer body image and community participation. A new prosthesis designed by the investigators' group allows Veterans with amputations to use their footwear of choice using 3D-printed artificial feet with a single ankle. The novel prosthesis will be tested in this project with women Veterans with amputations to determine the impact of improving footwear options on body image and community participation.
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.
Osteoarthritis (OA), the most common type of arthritis, affects more than 32.5 million adults in the United States. It is also among the most expensive condition to treat when joint replacement surgery is required. Although biomechanics plays an important role in OA disease, the non-surgical treatment options addressing biomechanics are scarce with limited effect. AposHealth is the fist biomechanical treatment that was shown to have a significant short-term effect on patients with knee OA. The main objectives of this study are: 1. To assess AposHealth, a non-invasive home-based biomechanical treatment, as an alternative treatment for patients who are eligible for Total Knee Replacement (TKR). 2. To assess AposHealth as a new post-operative rehabilitation tool for patients post TKR.
The purpose of this study is to determine the best assistance level of an exoskeleton footwear (EF) that can assist walking for people older than 40 with and without peripheral artery disease (PAD). The test will be performed on two different groups of people for this study that include: 1) people with PAD, and 2) individuals who don't have PAD. Data will be collected from 50 healthy older individuals and 25 patients with PAD, both groups will be 40 years or older. Gait biomechanics, muscle oxygenation, and energy cost for seven different walking conditions including normal walking, walking with EF with no assistance, and walking with EF with 5 different levels of assistance will be collected from the healthy older individuals. Additionally, subject-reported outcomes after each walking conditions including perceived comfort and fatigue, rate of perceived exertion and feasibility of the EF will be collected. Gait biomechanics, muscle oxygenation, energy cost, and patient-reported outcomes will be measured in patients with PAD for four walking conditions including normal walking, walking with EF but no assistance, walking with EF with the best two assistance levels. Subjects will be allowed to acclimate to the EF prior to recording data. All patients with PAD will participate in feasibility interviews that will assess acceptability, demand, implementation, and practicality. All subjects will be asked to fill out questionnaires that assess quality of life, physical function, and the ability to complete activities of daily living.
Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and experience walking activity limitations that negatively influence their ability to participate in day to day life. Ankle Foot Orthoses (AFO) are a fundamental rehabilitation strategy to facilitate walking in children with CP; yet, a review suggests that efficacy of the "traditional" solid AFO (TSAFO) in this population remains equivocal. A novel decision tree to guide orthotic prescription proposes a patient-specific method for adjusting AFO alignment and integrating footwear modifications (Ankle Foot Orthoses-Footwear Combinations, AFO-FC). This approach is based on visualizing the sagittal plane orientation of the ground reaction force vector with respect to lower limb segments during gait. The AFO-FC represents a paradigm shift in orthotic management as it accommodates ankle equinus contractures in a rigid AFO, reorients the tibial segment with a heel wedge under the AFO, and applies different heel, midsole and forefoot shoe modifications to restore lost ankle-foot rockers. The primary goal of AFO-FCs are to improve stability by facilitating more normal segment kinematics in single limb stance, decreasing hip/knee flexion. Despite their promise, evidence of an immediate positive effect on midstance alignment is limited, with no evidence of clinical effectiveness. This proposal assesses the feasibility of using a randomized waitlist study to acquire pilot data on a targeted clinical cohort of children with CP evaluating the effectiveness of AFO-FCs as compared to TSAFO during daily life. Individual joint and combined kinematics and kinetics will be examined for potential mechanisms of action as well as daily walking performance, balance and satisfaction with the AFO-FC in 30 ambulatory children with CP, ages 4-9 years, with bilateral crouch or equinus gait pattern, comparing gait in TSAFO to the AFO-FCs.
The purpose of this study is to address footwear challenges unique to women prosthesis users. Comparing the effectiveness of different footwear and prosthesis combinations will help guide clinical decision making regarding the prescription of prosthetic devices, while keeping what the patient wants in mind. It is expected that these results will be used to generate new knowledge for the development of versatile prosthetic devices that accommodate a user's unique lifestyle while helping the patient to make good progress in rehabilitation. Investigators will characterize perceived limitations in footwear among women prosthesis users. Investigators think that women prosthesis users will be restricted in footwear choices and clothing choices due to the use of a prosthetic device. Specifically, investigators expect perceived limitations in footwear will be greater for shoes with higher heels than shoes without heels.
The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time. The secondary objectives comprise the evaluation of the insole's ability to provide appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain after short-term use. The safety and tolerability of the test articles in terms of adverse events (AE) will also be investigated.
The primary objective of this trial will be to demonstrate the ability of a 3/4 length foam insole to provide relief from pain due to plantar fasciitis or general heel pain when used in footwear over a 4-week period of time
FGBMM (footwear generated biomechanical manipulation) effects neuromuscular patterns of pelvic muscles. While there have been no published studies to our knowledge investigating the effect of FGBMM on urinary incontinence, FGBMM causes perturbations in balance and gait that create dynamics similar to dynamic lumbosacral stabilization exercises. The investigators propose that FGBMM induces the same bio-mechanical improvements as LPSE (lumbopelvic stabilization exercises) which have shown benefit for incontinence. Instead of instructing patients to co-contract the lower trunk and pelvic floor muscles as commonly done for LPSE, the shoes used in FGBMM can be calibrated in a way that causes this co-contraction to occur without the patient realizing. Beneficial pelvis and spine positioning can also be accomplished by strategic placement of the pods without having to instruct the patient on complicated maneuvers. Capitalizing on the excellent adherence and clinical benefits of FGBMM on related conditions, the investigators propose to evaluate the effects of FGBMM in addition to pelvic floor therapy for improving the symptoms of stress urinary incontinence in an urban inner city population.
This study evaluates the effects of specialized footwear on pain and knee loading in knee osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and knee pain.
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.
The investigators propose a randomized control trial to evaluate long term effects and effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of falling in older adults. Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling, frailty status, and adverse events Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical activities • Characterize the feasibility of the MBB AFO device on patient adherence, acceptability, user-friendliness, and perception of benefit for daily usage
The goal of this study is to determine whether improving foot strength through foot exercises and minimal footwear can provide improved outcomes over the short and long term. The main research question it aims to answer is: Can the minimal footwear intervention be used to improve the health of aging adults with plantar fasciitis?? Participants will be randomized into 2 groups. One group will receive minimal shoes and foot strengthening and foot flexibility exercises. The other group will receive supportive shoes, foot orthotic device and foot flexibility exercises. Participants' step count will also be monitored. Researchers will compare pain and physical function between the minimal footwear (MF) and the foot orthotic (FO) groups at each of the follow-up sessions.