View clinical trials related to Amputation, Traumatic.
Filter by:This study will allow us to assess whether the Point Partial confers functional and psychological benefit to persons with partial finger amputations in an unconstrained environment. The use of the Point Partial outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.
The objective of the device feasibility study will be to validate the user needs of the Point Partial system. This study will be a single group intervention model where one group of 5 partial finger amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.
ORTHOPUS develops assistive technologies to address the lack of availability of medical devices in low and middle income countries. With the help of HI (Handicap International) Nepal, the need for upper limb prostheses was identified. Indeed, according to the literature - especially Efficiency of voluntary opening hand and hook prosthetic devices: 24 years of development? (JRRD, Volume 49, Number 4, 2012) -, today available solutions do not fully address patients' needs. In Nepal, only 2 upper limb prostheses options are generally proposed to patients because of supply and cost constraints. ORTHOPUS' objective is to extend patients' autonomy with a new set of prosthetic solutions. By offering low cost but high quality devices (according to CE marking requirements), another of the ORTHOPUS' missions is also to address supply and cost constraints. To improve patients' capabilities, ORTHOPUS aims at extending grasping capabilities compared to the usual passive aesthetic hand or voluntary opening one by proposing the following set of solutions: - an aesthetic articulated hand - a mechanical wrist - a work hook In order to assess the different stated hypotheses, a clinical trial is set jointly with HI Nepal. 14 patients will be enrolled in 2 cohorts (n1 = 7, n2 = 7), the first one is constituted with patients usually using an aesthetic passive hand whereas the second one comprise patients normally equipped with voluntary opening hand. After selecting and getting the informed consent of the patients, a month to make the sockets and adapt it to patients is planned. An evaluation of their quality of life will be done with the WHO QOL - BREF quality of life assessment before and after the test period of the trial. ORTHOPUS' set of prosthetic solutions will be tested by them over one month. They will have to fill on a daily basis a survey (OPUS) assessing their use of the prostheses. At the end of the test period, different questionnaires and surveys will be filled during a last interview to collect data. Data will be analysed in order to extract evidence for or against the trial hypotheses. With these results, a report will be written and submitted to the GATE (Global Cooperation on Assistive Health Technology) community managed by WHO. This report will also feed the ORTHOPUS R&D with patients' feedbacks and, research findings will be shared publicly on different social media in respect with patient privacy.
The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.
This study will allow us to assess whether the Point Digit confers functional and psychological benefit to persons with partial hand amputations in an unconstrained environment. The use of the Point Digit outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.
The purpose of this research is to test an investigational fabrication system for transtibial prostheses. This fabrication method will be tested for comfort and function to determine feasibility of use for amputees in developing countries. To address the need for high quality and affordable prosthetic technology in developing countries, the investigators have developed a simplified socket fitting protocol using expandable rigid foam. The foam is formed by mixing small amounts of two liquid components, which typically expands to several times its original volume.
The purpose of this study is to determine the effectiveness of therapeutic dose intravenous heparin at improving replantation/revascularization success and its indications (if any) in participants who have suffered traumatic digital amputation. Digital replantation/revascularization success will be assessed in participants who receive continuous intravenous drip of thromboprophylactic heparin at a therapeutic dose (i.e. modifies INR to the desired range) contrasted to those who do not receive therapeutic dose heparin (i.e. does not modify INR to the desired range). In the study, replantation/revascularization success is defined as a clearly viable digit at the time of discharge. Secondary objectives include assessing postoperative complications associated with heparin use, such as bleeding, hematoma or heparin induced thrombocytopenia. The investigators would also assess the impact of categorical variables such as smoking status, mechanism of injury and comorbidities, on digital survival.
Study assessing four-channel prosthesis controller, that compares contralateral (mirrored) EMG-force training to ipsilateral EMG-target training with both limb-absent and able-bodied subjects
The purpose of this graduate student research study is to test that a specifically designed and novel robotic prosthetic leg (RPL) is feasible, safe and improves symmetry, efficiency, and metabolic function during sit-to-stand and stand-to-sit transitions as compared to the subject's prescribed device, and as compared to no device at all.
Lower limb amputation (LLA) commonly affects young and active people who have long life expectancy. It is a major surgery causing many functional deficiencies which can reduce overall health quality and physical condition of the wounded persons and necessitating a multidisciplinary rehabilitation programme. High-frequency ultrasonography (US) is useful in evaluating peripheral nerves because of it has many superiority to other techniques. The advantages of US is; it has high resolution but no ionized radiation. It is possible to make dynamic and real-time imaging. It was showed that US have the same specificity and more sensitivity than magnetic resonance (MR) imaging in evaluating peripheral nerves. The aim of this study is to evaluate the sciatic, tibial and peroneal nerves of traumatic lower-limb amputees with the help of sonography and find the relationship between sonographic values and clinical characteristics.