View clinical trials related to Amputation.
Filter by:This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral osseointegrated (OI) prostheses. A limb-load biofeedback training group (EXP (n=10)) will be compared to a standard of care attention-control group without limb-load biofeedback training (CTL (n=5)). Outcomes will be assessed at standard of care pre-habilitation end (Week 5), standard of care rehabilitation end (Week 24), and one year after OI Stage 2 surgery (Week 64).
The study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type II (herein referred to as dysvascular amputees). The technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees.
The low mechanical loading of bones among wheelchair users leads to an increased risk of bone fractures and associated complications due to low bone mineral density (BMD). Adding mechanical loading through physical activity in combination with optimizing nutrition may counteract these negative consequences in wheelchair users and thereby provide positive impact for bone health, as well as for physical and mental health. In this project, a multidisciplinary team will tailor a bone-specific exercise and nutrition program to increase BMD in sport active and non-active wheelchair users with initial low BMD.
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.
After transtibial amputations, biomechanical changes in the trunk, pelvis, and lumbar region cause asymmetrical strength and core muscle activation on the amputated side, which negatively affects the gait biomechanics of individuals. However, routine treatment programs do not use treatment approaches based on the core region. This study will focus on the effects of telerehabilitation and face-to-face spinal stabilization exercise training on gait, balance, joint position sense, core muscle function, and perceived mobility in transtibial amputees, after treatment, and after long-term follow-up.
To attain high levels of mobility, people with lower limb amputation must build both the skill and the confidence to rely on their prosthesis in the environments that they will encounter in daily life. The purpose of this research is to determine whether practicing walking on an uneven terrain surface, specifically designed to present a modest, manageable disturbance to walking, can improve balance, locomotor flexibility (i.e. the ability to adapt walking to different walking contexts) and balance confidence, to a greater extent than walking on level ground alone. This preliminary study aims to determine whether uneven terrain walking is feasible and acceptable in the target population, and also to establish preliminary efficacy.
Lower extremity amputation patients represent a frail group of patients with extensive comorbidity. The most common indication of amputation is ischemia, infection and concomitant ischemic pain due to underlying chronic disease, especially arteriosclerosis and diabetes. Prolonged general anesthesia and surgery as well as increased blood loss may result in impaired patient safety. Previous studies have shown total blood loss approx. 1000 mL in transfemoral amputations (TFA). Substantial blood loss during surgery increases the risk of anemic complications and death for this already weakened patient group. The aim of this randomized controlled trial is to improve patient safety by exploring the possibility of a more precautious surgical procedure for TFA. Hence, investigating the total blood loss and secondary differences in complications after TFA between patients operated with use of pneumatic tourniquet versus no tourniquet. Total blood loss is calculated via Nadlers approach. From a pilot series, sample size was calculated to 124, allocated 1:1 in two groups of 62 participants, to ensure detection of at least 200 mL difference in total blood loss. The hypothesis is that use of tourniquet will decrease the total blood loss, the amount of blood transfusions, time of surgery and complications related to postoperative anemia without a higher rate of adverse events. The secondary and explorative outcomes are blood transfusions, intraoperative blood loss, length of stay, time of surgery, risk of readmission, risk of re-operation, risk of mortality, complications during admission, quality of life (QoL), prosthesis use and the prosthesis-specific survey Prothesis Evaluation Questionnaire (PEQ). QoL is measured with the validated questionnaire EQ-5D-5L preoperatively, and at 3, 6, and 12 months postoperatively. The possibility to enhance patient safety is highly relevant, and this trial will aid in establishing evidence-based guidelines for TFA surgery.
The investigators will investigate the device feasibility of human peripheral nerves and muscles recording and stimulation using percutaneous Utah Slanted Electrode Arrays (pUSEAs) implanted into residual peripheral arm nerves and EMG electrodes implanted in the residual muscles of patients with limb amputations in order to determine the ability of the HAPTIX (Hand Proprioception and Touch Interfaces) System to control an upper-extremity prosthesis, and to provide a sense of cutaneous touch and muscle proprioceptive feedback to the amputee.
Neuropathy is a costly and disabling health issue, which consists of a degeneration of the peripheral nerves. Even though the causes may be different, such as diabetes or amputation, the consequences for neuropathic patients are multiple and extremely debilitating. Among the alarming symptoms it implicates, chronic pain and sensory loss are among the most severe ones. Because of the loss of sensations, patients are forced to have an altered gait strategy, an impaired balance and a fivefold increased risk of falling. Furthermore, since they lose sensations and feel numbness in their extremity, they are discouraged in walking, hence leading to a sedentary lifestyle. All of this is worsened by the development of neuropathic pain, which has a high comorbidity with psychological issues, such as depression and anxiety. Today, proper treatments for neuropathic pain that exclude pharmacological solutions are still missing. This is due to the complexity of the neurobiological mechanisms underlying the origin of neuropathy, the multifaceted physical and psychological nature of pain and the lack of reliable biomarkers. The aim of this project is to tackle the major problems connected to neuropathy thanks to non-invasive stimulation of the peripheral nervous system. The system is composed of an insole with pressure sensors that captures in real time the force exerted by the subject on the foot and couples this information with parameters of electrical stimulation. Thanks to optimal electrode placement and intensity modulation, subjects are able to perceive in real-time in a somatotopic manner (i.e., under their foot) how they are walking. The aim now is twofold: first the investigators want to couple this stimulation with Virtual Reality (VR) to develop a neuroadaptive non-invasive brain computer interface (BCI) to treat pain and secondly the investigators want to measure through fMRI scans whether the use of the sensory feedback system allows any beneficial plastic changes in the brain. Finally, the investigators want to measure through fMRI scans whether the use of the sensory feedback system allows any beneficial plastic changes in the brain.
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.