Does socket liner material affect clinical outcomes in lower limb prosthesis users? Insights from a randomized control trial.

Among the noted disadvantages of prosthesis suspension by flexible liner is the increased rate of perspiration within the socket, which has the potential to cause discomfort, suspension issues, and tissue damage. In recent years, phase change material technology has been adopted for the use in prosthesis liners. These promise to improve temperature control and, consequently, reduce sweating. Previous work has demonstrated that this approach is effective in slowing the temperature increase at the limb-socket interface, but it was not clear how this would translate to clinical outcomes. This study had the aim to compare conventional and phase change material liners regarding prosthesis utilization, physical performance, and patient-reported outcome measures. A randomized double-blind cross-over study design with 6-month intervention periods was used. Of the 42 enrolled participants, only 50% completed the protocol. The high attrition was in large part because of the COVID-19 pandemic that started disrupting daily life and thereby the data collection midway through the study period. The findings indicate that the temperature control liners were, by trend, associated with better prosthesis utilization. The found effects did not reach the level of statistical significance, which is likely a result of the unduly reduced sample size.

Benefits of the Cybathlon 2020 experience for a prosthetic hand user: a case study on the Hannes system.

BACKGROUND: Cybathlon championship aims at promoting the development of prosthetic and assistive devices capable to meet users' needs. This paper describes and analyses possible exploitation outcomes of our team's (REHAB TECH) experience into the Powered Arm Prosthesis Race of the Cybathlon 2020 Global Edition, with the novel prosthetic system Hannes. In detail, we present our analysis on a concurrent evaluation conducted to verify if the Cybathlon training and competition positively influenced pilot's performance and human-technology integration with Hannes, with respect to a non-runner Hannes user. METHODS: Two transradial amputees were recruited as pilots (Pilot 1 and Pilot 2) for the Cybathlon competition and were given the polyarticulated myoelectric prosthetic hand Hannes. Due to COVID-19 emergency, only Pilot 1 was trained for the race. However, both pilots kept Hannes for Home Use for seven weeks. Before this period, they both participated to the evaluation of functionality, embodiment, and user experience (UX) related to Hannes, which they repeated at the end of the Home Use and right after the competition. We analysed Pilot 1's training and race outcomes, as well as changes in the concurrent evaluation, and compared these results with Pilot 2's ones. RESULTS: The Cybathlon training gradually improved Pilot 1's performances, leading to the sixth place with a single error in task 5. In the parallel evaluation, both pilots had an overall improvement over time, whereas Pilot 2 experienced a deterioration of embodiment. In detail, Pilot 1, who followed the training and raced the Cybathlon, improved in greater way. CONCLUSION: Hannes demonstrated to be a valuable competitor and to perform grasps with human-like behaviors. The higher improvements of Pilot 1, who actively participated in the Cybathlon, in terms of functionality, embodiment and UX, may depend on his training and engagement in the effort of achieving a successful user-prosthesis interaction during the competition. Tasks based on Cybathlon's ones could improve the training phase of a prosthetic user, stimulating dexterity, prosthetic integration, and user perception towards the prosthesis. Likewise, timed races or competitions could facilitate and accelerate the learning phase, improving the efficiency and efficacy of the process.

Impact of the COVID-19 restrictions on physical activity and quality of life in adults with lower limb amputation.

BACKGROUND: This study investigated the impact of COVID-19 restrictions on ambulatory activity and health-related quality of life (HR-QoL) in people with a lower limb amputation (LLA) in Norway. We hypothesized that the restrictions would negatively affect HR-QoL and decrease prosthetic wear time and ambulatory activity in participants with already limited mobility. METHODS: Twenty individuals with LLA (age and time since amputation 56.2 ± 11.9 and 22.3 ± 20.1 years, respectively) participated. Ambulatory activity (stepwatch: prosthetic wear time; steps per day; minutes of low-intensity (1-15 steps min-1), moderate-intensity (16-40 steps min-1), and high-intensity ambulation (>40 steps min-1)) and HR-QoL (EQ-5D-5L) data were collected prepandemic and 8-12 months later during pandemic restrictions. Semistructured interviews identified personal experiences of coping with restrictions. RESULTS: Prosthetic wear time decreased significantly (-1.0 ± 1.5 hours day-1, p < 0.05). Steps per day (440 ± 1481), moderate-intensity and high-intensity ambulation (3.7 ± 23.4, and 4.8 ± 13.9 minutes day-1, respectively), and EQ-5D-5L index (.02 ± .10) increased, whereas low-intensity ambulation decreased (-1.5 ± 16.1 minutes day-1), all nonsignificant changes. Qualitative analysis identified three themes related to coping with restrictions: (1) personal situation, (2) a prosthetic user's perspective, and (3) mindset. CONCLUSIONS: Increased time spent at home might explain the decreased prosthetic wear time. Contrary to the hypothesis, participants did not decrease their physical activity, and the declined low-intensity ambulation was offset by increased moderate-intensity and high-intensity ambulation. A positive mindset, intrinsic motivation, and health awareness may be important factors for maintaining ambulatory activity and HR-QoL in people with LLA.

Extended Reality "X-Reality" for Prosthesis Training of Upper-Limb Amputees: A Review on Current and Future Clinical Potential.

The rejection rates of upper-limb prosthetic devices in adults are high, currently averaging 26% and 23% for body-powered and electric devices, respectively. While many factors influence acceptance, prosthesis training methods relying on novel virtual reality systems have been cited as a critical factor capable of increasing the likelihood of long-term, full-time use. Despite that, these implementations have not yet garnered widespread traction in the clinical setting, and their use remains immaterial. This review aims to explore the reasons behind this situation by identifying trends in existing research that seek to advance Extended Reality "X-Reality" systems for the sake of upper-limb prosthesis rehabilitation and, secondly, analyzing barriers and presenting potential pathways to deployment for successful adoption in the future. The search yielded 42 research papers that were divided into two categories. The first category included articles that focused on the technical aspect of virtual prosthesis training. Articles in the second category utilize user evaluation procedures to ensure applicability in a clinical environment. The review showed that 75% of articles that conducted whole system testing experimented with non-immersive virtual systems. Furthermore, there is a shortage of experiments performed with amputee subjects. From the large-scale studies analyzed, 71% of those recruited solely non-disabled participants. This paper shows that X-Reality technologies for prosthesis rehabilitation of upper-limb amputees carry significant benefits. Nevertheless, much still must be done so that the technology reaches widespread clinical use.

Real-Time Internet of Medical Things System for Detecting Blood Leakage during Hemodialysis Using a Novel Multiple Concentric Ring Sensor.

Venous needle dislodgement (VND) is a major healthcare safety concern in patients undergoing hemodialysis. Although VND is uncommon, it can be life-threatening. The main objective of this study was to implement a real-time multi-bed monitoring system for VND by combining a novel leakage-detection device and IoMT (Internet of Medical Things) technology. The core of the system, the Acusense IoMT platform, consisted of a novel leakage-detection patch comprised of multiple concentric rings to detect blood leakage and quantify the leaked volume. The performance of the leakage-detection system was evaluated on a prosthetic arm and clinical study. Patients with a high risk of blood leakage were recruited as candidates. The system was set up in a hospital, and the subjects were monitored for 2 months. During the pre-clinical simulation experiment, the system could detect blood leakage volumes from 0.3 to 0.9 mL. During the test of the IoMT system, the overall success rate of tests was 100%, with no lost data packets. A total of 701 dialysis sessions were analyzed, and the accuracy and sensitivity were 99.7% and 90.9%, respectively. Evaluation questionnaires showed that the use of the system after training changed attitudes and reduced worry of the nursing staff. Our results show the feasibility of using a novel detector combined with an IoMT system to automatically monitor multi-bed blood leakage. The innovative concentric-circle design could more precisely control the warning blood-leakage threshold in any direction to achieve clinical cost-effectiveness. The system reduced the load on medical staff and improved patient safety. In the future, it could also be applied to home hemodialysis for telemedicine during the era of COVID-19.

The Use of Smartphone Photogrammetry to Digitise Transtibial Sockets: Optimisation of Method and Quantitative Evaluation of Suitability.

The fit of a lower limb prosthetic socket is critical for user comfort and the quality of life of lower limb amputees. Sockets are conventionally produced using hand-crafted patient-based casting techniques. Modern digital techniques offer a host of advantages to the process and ultimately lead to improving the lives of amputees. However, commercially available scanning equipment required is often expensive and proprietary. Smartphone photogrammetry could offer a low cost alternative, but there is no widely accepted imaging technique for prosthetic socket digitisation. Therefore, this paper aims to determine an optimal imaging technique for whole socket photogrammetry and evaluate the resultant scan measurement accuracy. A 3D printed transtibial socket was produced to create digital and physical twins, as reference models. The printed socket was photographed from 360 positions and simplified genetic algorithms were used to design a series of experiments, whereby a collection of photos were processed using Autodesk ReCap. The most fit technique was used to assess accuracy. The accuracy of the socket wall volume, surface area and height were 61.63%, 99.61% and 99.90%, respectively, when compared to the digital reference model. The scanned model had a wall thickness ranging from 2.075 mm at the top to 7.758 mm towards the base of the socket, compared to a consistent thickness of 2.025 mm in the control model. The technique selected did not show sufficient accuracy for clinical application due to the degradation of accuracy nearer to the base of the socket interior. However, using an internal wall thickness estimation, scans may be of sufficient accuracy for clinical use; assuming a uniform wall thickness.