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Showing 1-13 of 13 trials
NCT07418645
The aim of this study is to evaluate the effect of integrating tactile feedback systems into a robotic upper-limb prosthesis. These systems deliver pressure stimuli (through small silicone chambers that inflate), vibration stimuli (through small circular actuators), or a combination of both to the arm, in order to improve the feeling of owning and controlling the artificial hand. In this way, when the robotic hand touches, grasps, and holds an object, the user receives sensory feedback that may make prosthesis use more natural, intuitive, and functional in everyday life. This is expected to improve the sense of bodily integration of the prosthesis, particularly by enhancing the perception of owning the bionic limb and the feeling of control over it, thereby improving the ability to perform daily activities with the prosthesis. In addition, the study aims to investigate whether the simultaneous delivery of multiple stimuli may confuse or discomfort the user or they are well integrated by the sensitive system improving the experience of tactile sensation. This is a pilot, open-label study, meaning that both the researchers and the participants will be aware of the different phases of the study. The study population will include individuals with unilateral transradial upper-limb loss, either acquired or congenital. The planned sample size is 9 participants who meet the inclusion and exclusion criteria and who provide written informed consent to take part in the study. The study consists of two phases. Phase 1: Rubber Hand Illusion experiment During this phase, the feedback devices called WISH (pressure sensation provided by the inflation of silicone chambers), VIBES (vibration sensation), and PUSE (both devices applied and activated together to provide both sensations, either synchronously or with minimal delay) will be placed on the residual limb and secured with elastic Velcro straps. A robotic hand, controlled by the participant through electromyographic sensors, will be positioned on a table in front of the participant. The participant will see the robotic hand move while receiving sensory feedback synchronized with its movements. Different stimulation conditions (pressure only, vibration only, and combined feedback) will be tested. At the end of each condition, a questionnaire will be administered to assess the perception of ownership and agency. Phase 2: Upper-limb prosthesis use In the second phase, the actuators will be integrated into the socket of a SoftHand robotic prosthesis, a myoelectric upper-limb prosthesis. Participants will be asked to wear the prosthesis and perform tasks under each of the feedback conditions tested in Phase 1. After a free-use familiarization period of approximately 10 minutes, participants will be asked to perform tasks involving object and surface recognition, as well as activities of daily living, which will be timed. The results of the different conditions will be compared to identify the feedback configuration associated with the best performance, defined as fewer errors and shorter execution time. At the end of each condition, a questionnaire will be administered to assess ease of use and tolerability of the prosthesis.
NCT05124873
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by unbreathable and non-thermally conductive materials that can create a warm and ultimately moist environment. The investigators have developed a silicone liner approach to passively conduct heat from the skin using thermally conductive elastomers. A technology that can provide thermal control while retaining adequate suspension, weight, and other prosthetic characteristics would benefit many prosthesis wearers.
NCT04427007
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. The investigators have developed a silicone liner approach to remove sweat from the skin and out of the socket and to passively conduct heat from the skin using thermally conductive elastomers. This liner has been developed to work alongside a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE) developed in a parallel project by Vivonics, Inc. and Liberating Technologies, Inc. The ICE device can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight, and other prosthetic characteristics would benefit many prosthesis wearers.
NCT06424249
Amputation causes somatic and psychological damage. Prognostic factors for postoperative gait recovery include the need for proprioceptive re-education for dynamic balance. Improved gait patterns and use of the prosthesis contribute to an overall improvement in the amputee's autonomy. Virtual reality coupled with movement analysis allows personalization of treatment with objective assessment of progress. The study authors hypothesize that a virtual reality protocol for the dynamic balance of a unilateral transtibial amputee in initial rehabilitation will improve the dynamic balance assessment criteria compared with a conventional rehabilitation protocol.
NCT06849934
The primary aim of this study was to find the reliability of Kinovea software in measuring parameters associated with sagittal plane knee kinematics during gait in transtibial amputees. The secondary objective was to calculate the absolute reliability by calculating the Standard Error of Measurement (SEM), SEM% and Minimal Detectable Change at 95% confidence interval (MDC95). The SEM value represents the extent to which a score changes during the repetition of the measurement. The MDC is the minimum change in the measurement that is considered a true change in the measured activity that is not due to error.
NCT06486571
Upper limb amputation still causes severe disability today; prostheses currently on the market are able to restore partially to the amputee the lost functionality. In addition to the motor capacity of the limb, prosthetic systems should also aim to restore to the sensory information from the surrounding environment during contact with objects. Therefore, it is important to develop bidirectional prostheses. It is thus apparent that the development of new techniques for decoding the efferent channel, such as high-density surface electromyography, and for encoding of the afferent channel afferent, to return multimodal somatosensory sensations of mechanoception, nociception, and thermoception using TENS, isimportant to improve the patient's use of the prosthesis.
NCT03722797
This cross-sectional study explores physical activity and energy expenditure among inactive adults with a unilateral transtibial amputation. Results may assist with physical activity prescription for adults with unilateral lower-limb loss.
NCT02346019
The purpose of our study is to improve the fit and function of prosthetic sockets for above the knee amputees through the use of an outpatient thigh reduction surgical procedure.
NCT02761447
This study evaluates the effectiveness of imagery motor on phantom pain and amputation process
NCT01236170
The Department of Veterans Affairs (VA) provides wheelchairs to about 42,000 Veterans with SCI and more than 40,000 Veterans with amputated limbs (AL). Despite VA's efforts to remove financial and other barriers to the provision of wheelchairs to all Veterans who need them, preliminary evidence suggests that disparities exist in the quality of wheelchairs prescribed to racial minorities and low income Veterans with SCI or AL. The proposed project will provide important information to the VA about the quality and equity of wheelchairs provided to Veterans with SCI or AL, and it will identify the patient and provider factors associated with wheelchair provision. Because Veterans with SCI and AL are considered special disability populations, identifying and understanding these factors is a critical first step to developing interventions to increase the quality and equity of wheelchairs provided to all disabled Veterans.
NCT00458757
In this study, we wish to find behavioral evidence for the question whether an amputation of the arm can lead to changes in visual perception or motor responses to objects in peripersonal space. We hypothesize that changes in the motor and somatosensory hand-related cortices following amputation might lead to changes in parietal hand-related areas. The consequence of these parietal changes should be reflected behaviorally in reduced perception/attention/responses to hand-related objects in the space ipsilateral to the amputation. We further hypothesize that the use of prosthetics may provide the necessary visual feedback to maintain an intact hand representation and therefore lead to lesser cortical reorganization in both visual and somatosensory cortical areas.
NCT02875197
The purpose of this research is to provide clinically, administratively, and field-relevant objective running outcomes by directly comparing running biomechanics of individuals with lower extremity amputation (ILEA) using RSPs (Running Specific Prostheses) and traditional prostheses. Within this purpose, the project has two specific aims: Specific Aim 1: To compare RSPs and traditional prostheses with respect to running ability and performance Specific Aim 2: To compare RSPs and traditional prostheses with respect to injury risks associated with running Hypothesis 1a: RSPs will outperform traditional prostheses at all velocities as measured by kinetic data (ground reaction forces, joint powers, joint and limb work) and 50m dash time. Hypothesis 1b: ILEA intact limbs and able-bodied control limbs will outperform residual limbs with RSPs and traditional prostheses at all velocities as measured by kinetic data. Hypothesis 2: Running with RSPs will show reduced acute and chronic injury risks compared to traditional prostheses at all velocities as measured by loading rates, EMG amplitudes, lumbopelvic kinematics, and modeled joint loads.
NCT02297295
The purpose of this study is to determine whether exercise medicine in lower limb amputees has a impact on the three domains of the International Classification of Functioning of the WHO (function, activities and participation), and on quality of life.