View clinical trials related to Amputation.
Filter by:This study will aim at performing biomechanical analyses of the actual load applied on the end of the stump (residuum) of individuals with transfemoral limb loss fitted with bionics bone-anchored prostheses during activities of daily living. The assessment of the inner prosthetic loading will rely on the analyses of common activities of daily living (e.g., walking in straight line and around circles, ascending and descending stairs and slopes, cycling, etc.) performed in experimental and/or clinical and/or open environments. The biomechanical analyses of the load will address the following research questions: A. What is the actual magnitude of the forces and moments applied on transfemoral osseointegrated implant by Rheo Knee and Power Knee during activities of daily living? living? B. What are the determinants of the loading profile in relation to the demographic and anthropometric characteristics, the type and level of activities as well as type, fitting and alignment of Rheo Knee and Power Knee? C. How the loading profiles applied by Rheo Knee and Power Knee compared to usual MPKs and Non-MPK considered below standard of care? Biomechanical data will be collected through a typical cross-sectional cohort study. Each participant will be assessed with a given prosthesis at one particular time (i.e., exposure and outcomes will be both measured at the same time). These biomechanical analyses will rely on already published protocols (e.g., study design, instrumentation setup, extraction of loading profile). Protocols to record load data have been well described by PI-Frossard in over 20 peer-review publications in top-ranked journals. The protocol used in this study has been acknowledged, validated and are commonly used within the fields of biomechanics and prosthetics. The outcome of this study will increase the basic understanding about the effects of loading on the interaction between body and prosthesis (e.g., osseointegration between residual bone and implant). The study will also increase applied knowledge required to establish stronger evidence-based rehabilitation programs, fitting of prosthetic limbs and design of bionics prosthetic components. It is anticipated that, both basic and applied knowledge gain in this study will, all together, contribute to increase the health-related quality of life of individuals fitted with socket and bone-anchored prostheses.
Background: Peripheral arterial disease (PAD) is the main cause of amputation to the lower limb within the UK, affecting over 20% of adults older than 70 years. After an amputation, individuals often use a wheelchair and do not walk with a prosthetic limb. This is due to them experiencing: older age, muscle weakness, pain, other health conditions limiting ability to exercise eg. heart problems. Healthcare professionals assess physical function with Physical Performance Based Outcome Measures (PerBOMs). A PerBOM requires an individual to complete tasks that are part of their day to day life e.g. walking or balance. PerBOMs are used with for: - Setting goals with patients - Assessing how patients respond to treatment/rehabilitation - Predicting if patients are likely to use a prosthetic limb in the future Previous research shows most of the available PerBOMs are suitable an amputee who walks with a prosthetic limb. However, most vascular amputee patients cannot benefit from these assessments. Therefore, based on this evidence we have developed a new PerBOM to help manage vascular amputees who do not walk with a prosthetic limb. Methods: Qualitative interviews and focus groups with amputee individuals and healthcare professionals who treat them. Approaching individuals who have or will undergo an amputation to their leg due to PAD. Approaching healthcare professionals through professional networks. Interviews and focus groups will take place face to face or remotely by telephone/video conferencing, lasting approximately 1-2 hrs. In the interview or focus group, the researcher will explain and show individuals a video of the new PerBOM and explore their opinions qualitatively on this new PerBOM. All audio will be recorded, written up and analysed. All findings will be presented at scientific conferences. This study has been developed with patients and public involvement.
This study is a randomized controlled trial (RCT) to evaluate outcome after toe amputation due to diabetic foot infection. Aim of this RCT is to evaluate wound healing and functional outcome based, whether wound is closed or left open. As a part of this study, emerging technology of thermal imaging is evaluated as a possible tool to predict complication after amputation.
Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor wound healing, new infections and/or new ulcers. Research to date has focused on patient-related factors associated with poor wound healing (e.g. diabetes, lack of blood flow, poor kidney function). However, there is no research looking at the technical surgical aspects of the procedure, specifically how the toe bone is cut. For this feasibility study, we will recruit forty patients whom a consultant vascular surgeon has decided requires amputation of one-to-two adjacent toes. The participants will be randomised by a computer model into one of the two metatarsal transection methods (bone cutters or bone saw) and the rest of the procedure will be carried out in the standard fashion. Patients and assessors will be blinded to which transection method is chosen. Patients will undergo a post-operative foot x-ray to assess for bone fragments within 48 hours of surgery and another at six months to assess for bone healing. Patients will be asked to rate their pain in the post-operative period using the verbal rating score. Patients will be followed after discharge from hospital by their public health nurse, as is standard practice, with regular follow-up in the surgical outpatients to assess wound progress. Patients will be asked to rate their quality of life at six weeks and six months post-operatively. These assessments will be coordinated with their routine post-operative follow-up clinic appointments, so as not to inconvenience patients with supernumerary visits.
The goal of this multicenter, multi-national, multi-arm, multi-stage, randomized controlled trial, is to determine the added benefit of hyperbaric oxygen treatment (HBOT) in patients with diabetic foot ulcers and peripheral vascular disease. The main question is: - What is the difference is the major amputation rate between the study arms? Participants will be randomized to 20, 30 or 40 sessions of HBOT or a control group.
People with limb loss receiving inpatient rehabilitation are at greater risk for depression and anxiety, social isolation, and generally have poorer quality of life. To proactively address the mental health needs of this population, St. John's Rehab recruited two psychiatrists to provide mental health support to their inpatient population groups. Because there are limits to mental health resources and because group therapy facilitates patients learning from each other, the investigators plan to test an innovative psychological group therapy program designed for limb loss inpatients to address mental health challenges, and to better prepare them to integrate back into the community. Our designed psychosocial group therapy is led by a psychiatrist and an occupational therapist who create a structured process for inpatients to discuss their challenges and identify coping strategies that will help them transition back into the community. The investigators will recruit 130 inpatients with limb loss, with 65 taking part in a weekly psychosocial group therapy program and 65 receiving treatment as usual. The investigators will evaluate if anxiety and depression significantly decreases in our treatment group compared to those who received treatment as usual. The findings of this work will provide needed evidence for the clinical feasibility and utility of a rehabilitation inpatient group therapy program, which can serve as a useful model for other limb loss sites across Canada.
It is unclear why humans typically swing their arms during gait. To date, the debate on how to arm swing comes about (i.e. whether it is caused by accelerations of the shoulder girdle or muscular activity) is still going on. There needs to be consensus on whether the arm swing is actively controlled or merely passive and on why humans swing their arms during walking (i.e. what the purpose of arm swing is, if any). Suggested reasons include minimising energy consumption, optimising stability, and optimising neural control. Pathologies such as hemiplegia after stroke, Parkinson's disease, Cerebral Palsy, Spinal Cord Injury, and Multiple Sclerosis may directly affect arm swing during gait. Emerging evidence indicates that including arm movements in gait rehabilitation may be beneficial in restoring interlimb coordination and decreasing energy expenditure. This project hypothesises that the arms swing, at least at low and intermediate walking speeds, reflects the body's Center of Mass (CoM) accelerations. Arm swing may thus depend mainly upon the system's intrinsic mechanical properties (e.g., gravity and inertia). In this perspective, the CoM is seen as moving relative to the upper limbs rather than the other way around. The contribution of major lower limb joints, in terms of power injected into the body motion, will be simultaneously explored. The study aims to investigate the mechanism and functions of arm swinging during walking on a force treadmill. To simulate asymmetric walking, healthy subjects will be asked to walk with a toes-up orthosis to induce claudication and asymmetry in ankle power. In this way, it will be possible to highlight the correlation among arm swinging, ankle power, and the acceleration of the CoM in a 3D framework. In addition, subjects affected by unilateral motor impairments will be asked to walk on the force treadmill to test the experimental model and highlight significant differences in the kinematic parameters of the upper limbs. The question of whether arm swing is actively controlled or merely passive and the relationship between arm swinging and the total mechanical energy of the CoM will be faced. Asymmetric oscillations of the upper limb will be related to dynamic asymmetries of the COM motion, and of the motion of lower limbs. In addition, cause-effect relationships will be hypothesized. Finally, the dynamic correlates of upper limb oscillations will make the clinical observation an interpretable clinical sign applicable to rehabilitation medicine. Results from the present study will also foster the identification of practical rehabilitation exercises on gait asymmetries in many human nervous diseases.
The goal of this clinical trial is to test the impact of virtual reality on rehabilitation for the patients after a major amputation. The main questions it aims to answer are: - Does the virtual-reality-assisted rehabilitation improve the life quality of patients (i.e. lesser pain, better spirit)? - Does the virtual-reality-assisted rehabilitation improve the daily life function of the patients? Participants will received a virtual-reality-assisted rehabilitation on the second postoperative day for ten days. The rehabilitation would be carried out two times per day and 30 minutes per training.
The purpose of this research study is to see how well a new type of myoelectric prosthesis works. A myoelectric prosthesis is a robotic limb for amputees that is controlled by sensing the activity of muscles in the body above the amputation level. This study involves a medical procedure to implant the Myoelectric Implantable Recording Array (MIRA) in the residual limb. The procedure will be performed under sedation by a physician. When muscles contract, they generate an electrical signal that can be sensed by MIRA and used to control the prosthetic limb. Myoelectric prosthetic limbs normally use electrodes that are placed on the surface of the skin to control different movements. However, MIRA is implanted under the skin, which could improve the ability to control the myoelectric prosthesis. After the MIRA is implanted, training will occur to learn how to control the prosthesis using the muscles in the residual limb. The device can stay implanted for up to one year. The device will be removed (explanted) by a physician.
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.