View clinical trials related to Prosthesis User.
Filter by:The loss of an eye, whether congenital or acquired, is a severe psychological trauma with negative impact on the quality of life of the patient. While rehabilitation with a customized ocular prosthesis anatomically restores the facial appearance, the final outcome is largely determined by the subjective satisfaction of the patient. By investigating the level of subjective perception, the quality of care can be improved.
This study investigates whether simultaneous electromyographic (EMG)-based pattern recognition control of an upper limb prostheses increases wear time among users. In contrast to conventional, seamless sequential pattern recognition style of control which only allows a single prosthetic hand or arm function at a time, simultaneous control allows for more than one at the same time. Participants will wear their prosthesis as they would normally at home using each control style for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored; including, how often participants wear their device and how many times they move each degree of freedom independently or simultaneously. The primary hypothesis is that prosthetic users will prefer simultaneous control over conventional control which will result in wearing their device more often. The secondary hypothesis is that simultaneous control will result in more efficient prosthesis control which will make it easier for participants to perform activities of daily living. The results of this study will help identify important factors related to prosthetic users' preferences while freely wearing their device within their own daily-life environment.
Many different factors can degrade the performance of an upper limb prosthesis users control with electromyographic (EMG)-based pattern recognition control. Conventional control systems require frequent recalibration in order to achieve consistent performance which can lead to prosthetic users choosing to wear their device less. This study investigates a new adaptive pattern recognition control algorithm that retrains, rather than overwrite, the existing control system each instance users recalibrate. The study hypothesis is that such adaptive control system will lead to more satisfactory prosthesis control thus reducing the need for recalibration and increasing how often users wear their device. Participants will wear their prosthesis as they would normally at-home using each control system (adaptive and non-adaptive) for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored during each period in order to compare user wear time and recalibration frequency when using adaptive or non-adaptive control. Participants will also play a set of virtual games on a computer at the start (0-months), mid-point (1-months) and end (2-months) of each period that will test their ability to control prosthesis movement using each control system. Changes in user performance will be evaluated during each period and compared between the two control systems. This study will not only evaluate the effectiveness of adaptive pattern recognition control, but it will be done at-home under typical and realistic prosthetic use conditions.
This study was performed to determine the presence of any difference between Pin Suspension (PS) and Active Vacuum Suspension (AVS) on walking capacity, functional mobility, weight bearing in the prosthetic side, prosthetic satisfaction and body image were evaluated. Nine patients who don't have an obstacle to both socket applications in terms of stump height, type and edema were evaluated in this study. Both suspension systems were administered to the patients included in the study. First, amputees have used PS for 3 months following alignment of the prosthesis and training period. Then again they used AVS for 3 months following alignment of the prosthesis and training period. For each system, after adapting prosthesis 'LASAR posture' was used to evaluate weight bearing on the prosthetic side, '6 Minute Walk Test' for walking capacity, 'Time Up and Go' test for functional mobility, 'Prosthetic Satisfaction Index' for prosthetic satisfaction and 'Amputee Body Image Scale' for body. There were statistically significant difference between PS and AVS in terms of prosthetic side weight bearing percentage, walking capacity, functional mobility and prosthetic satisfaction (p<0.05), in favor of AVS. There were not statistically significant difference between the body image scores (p>0.05). From the view of function and prosthetic satisfaction, AVS was found to be more effective in transtibial amputees. It is believed that our study will be a guide to the future studies including higher number of amputees, different amputation levels and different suspension systems.
The aim of this study was to investigate the effect of a robot-assisted biofeedback exercise program on grip strength, movement speed, coordination, functional status, depressive status, and quality of life in patients with a myoelectric prosthesis with upper limb amputation. In the literature review, There is no robot-assisted exercise program applied in patients using upper extremity myoelectric prosthesis. The expected benefit from this study is to show that the functional status, depressive status, and quality of life of the patients who received robot-assisted biofeedback exercise were better than those who had a home exercise program only.
The aim of this study was to evaluate the mobility, perceived safety and functioning of unilateral transfemoral (TF) amputees using the Rheo Knee XC compared to their existing prosthetic knee (RHEO KNEE II, III or Genium, X2 or X3) after 3 weeks of use. The primary objective of the study was to determine/investigate whether unilateral (TF) amputees can apply and benefit from the stair ascent function of the Rheo Knee XC and compare the stair ascent function and automatic cycling detection of the Rheo Knee XC to hydraulic microprocessor controlled knees (MPK-HY). The testing was conducted in a non-blinded, multicenter, prospective within subject comparison, with a subgroup analysis with Magneto-rheologic microprocessor controlled knees (MPK-MR) subgroup and MPK-HY subgroup comparing to the Rheo knee XC. A convenience sample of 15 transfemoral amputee users was recruited at 4 study sites. Inclusion criteria: - Cognitive ability to understand all instructions and questionnaires in the study; - Unilateral knee-disarticulated or transfemoral users fitted to Rheo Knee II,III or Genium - Willing and able to participate in the study and follow the protocol - Confident prosthetic users for more than 3 months - Older than 18 years Exclusion Criteria - Patients with the following characteristics are not eligible for study entry: - 50Kg> body weight > 136Kg - Users with cognitive impairment - Users not understanding the function of the knee - Users not able to charge the battery Testing was conducted between June and August 2015 in four US locations. Participants visited the study location twice, for approximately 3 hours per visit. First time for the baseline measure and initial fitting and secondly after 3 weeks of accommodation on the Rheo knee XC, performing the same measures as for the baseline. Measures included 6 minute walk test with Borg scale CR pre and post, L-test, stair assessment index, stair and bicycle evaluation and Prosthesis evaluation questionnaire mobility section (PEQ MS12/5) For statistics repeated measures analysis of variance (ANOVA) comparing baseline to 3 week follow up were performed.
Implication and evaluation of a non-invasive sensory feedback system in hand prostheses in everyday life.
A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL.
Background: Evaluating the use of a novel motorized ankle prosthesis during walking and under dual task circumstances is an important step in product development. Objective: To iteratively evaluate the effectiveness of a novel bionic foot, the Ankle Mimicking Prosthetic device 4+ (or AMPfoot 4+), during walking. Study design: Case study (crossover) research design. Methods: One male subject will conduct a baseline experimental trial with the current prosthetic device and several experimental trials with the AMPfoot 4+ to evaluate the effectiveness of the novel device and investigate the adaptation period. Prior to baseline experiments, a familiarization trial will be performed to determine intra-subject variability of the dual task. An experimental trial consists of 2 walking tasks, i.e. the 6-minute walk test (6MWT) and the 10-meter walk test. The 6MWT will be combined with a cognitive task, i.e. backwards counting, to create dual task circumstances. The outcome measurements for the dual task are the distance covered and the walking speed, heart rate (HR) (Polar), rating of perceived exertion (RPE), VO2 (Cosmed K5), electro-encephalography (EEG), electro-myography (EMG), electro-cardiography (ECG), electrodermal activity (/skin conductance),accuracy and total duration of the cognitive task, BodyMedia (physical activity) and the visual analogue scale (VAS) for fatigue and comfort. A 10-meter walk test will be evaluated on duration. Expected findings: In a first phase the novel device will probably reduce walking and cognitive performance, whereas fine-tuning the mechatronics (after several retests) should improve walking and cognitive performance during walking.
Objectives: The main objectives are to determine neural dynamics during gait using electro-encephalography as well as brain sources and to investigate the attentional demand during walking in able-bodied individuals, and individuals with an amputation. Materials & Methods: 6 able-bodied individuals conducted one experimental trial, and 6 unilateral transtibial and 6 unilateral transfemoral amputees performed 2 experimental trials; the first with the current and the second with a novel powered transtibial prosthesis, i.e. the Ankle Mimicking Prosthetic foot 4.0. Each experimental trial comprised 2 walking tasks; 6 and 2min treadmill walking at normal speed interspersed by 5min of rest. During 6min walking the sustained attention to response (go-no go) task, with measures reaction time and accuracy, was performed. Electro-encephalographic (EEG) data were gathered when subjects walked 2min. Motor-related cortical potentials and brain activity during gait are extracted using EEG.