Moisture mitigation using a vented liner and a vented socket system for individuals with transfemoral amputation.

Sweating and heat buildup at the skin-liner interface is a major challenge for persons with limb loss. Liners made of heat-non-conducting materials may cause sweating of the residual limb and may result in liners slipping off the skin surface especially on a warm day or during high activity, causing skin breakdown and affecting limb health. To address this, we evaluated the efficacy of the vented liner-socket system (VS, Össur) compared to Seal-In silicone liner and non-vented socket (nVS, Össur) in reducing relative humidity (RH) during increased sweat. Nine individuals with limb loss using nVS were randomized to VS or nVS and asked for activity in a 20-min treadmill walk. RH was significantly attenuated (p = 0.0002) and perceived sweating, as reported by prosthesis users, improved (p = 0.028) with VS, patient-reported comprehensive lower limb amputee socket survey (CLASS) outcomes to determine the suspension, stability, and comfort were not significantly different between VS and nVS. There are limited rigorous scientific studies that clearly provide evidence-based guidelines to the prosthetist in the selection of liners from numerous available options. The present study is innovative in clearly establishing objective measures for assessing humidity and temperatures at the skin-liner interface while performing activity. As shown by the measured data and perceived sweat scores provided by the subjects based on their daily experience, this study provided clear evidence establishing relative humidity at the skin-liner interface is reduced with the use of a vented liner-socket system when compared to a similar non-vented system.

Loading characteristics data applied on osseointegrated implant by transfemoral bone-anchored prostheses fitted with state-of-the-art components during daily activities.

The data in this paper are related to the research article entitled "Load applied on osseointegrated implant by transfemoral bone-anchored prostheses fitted with state-of-the-art prosthetic components" (Frossard et al. Clinical Biomechanics, 89 (2021) 105457. DOI: 10.1016/j.clinbiomech.2021.105457). This article contains the overall and individual loading characteristics applied on transfemoral press-fit osseointegrated implant generated by bone-anchored prostheses fitted with state-of-the-art components during daily activities (i.e., microprocessor-controlled Rheo Knee XC knee, energy-storing-and-returning Pro-Flex XC or LP feet (ÖSSUR, Iceland)). Confounders of the loads are presented. The load profiles are characterized by the loading patterns, loading boundaries and loading local extrema of the forces and moments applied during straight-level walking, ascending and descending ramp and stairs at self-selected comfortable pace. The confounders of the loading information as well as new insights into inter-participants variability of loading patterns, loading boundaries and loading local extrema can inform the design of subsequent cross-sectional and longitudinal studies as well as literature reviews and meta-analyzes. The loading datasets are critical to clinicians and engineers designing finite element models of osseointegrated implants (e.g., medullar and percutaneous parts) and prosthetic components, algorithms capable to recognize the loading patterns applied on a residuum during daily activities, as well as clinical trials assessing the effects of particular prosthetic care interventions. Altogether, these datasets provide promoters of prosthetic care innovations with valuable insights informing the prescription of advanced prosthetic components to the growing population of individuals suffering from lower limb loss choosing bionics solutions. Online repository contains the files: https://data.mendeley.com/datasets/gmsyv97cpc/1.

Load applied on osseointegrated implant by transfemoral bone-anchored prostheses fitted with state-of-the-art prosthetic components.

BACKGROUND: This study presented the load profile applied on transfemoral osseointegrated implants by bone-anchored prostheses fitted with state-of-the-art ÖSSUR microprocessor-controlled Rheo Knee XC and energy-storing-and-returning Pro-Flex XC or LP feet during five standardized daily activities. METHODS: This cross-sectional cohort study included 13 participants fitted with a press-fit transfemoral osseointegrated implant. Loading data were directly measured with the tri-axial transducer of an iPecsLab (RTC Electronics, USA) fitted between the implant and knee unit. The loading profile was characterized by spatio-temporal gaits variables, magnitude of loading boundaries as well as onset and magnitude of loading extrema during walking, ascending and descending ramp and stairs. FINDINGS: A total of 2127 steps was analysed. The cadence ranged between 36 ± 7 and 47 ± 6 strides/min. The absolute maximum force and moments applied across all activities was 1322 N, 388 N and 133 N as well as 22 Nm, 52 Nm and 88 Nm on and around the long, anteroposterior and mediolateral axes of the implant, respectively. INTERPRETATION: This study provided new benchmark loading data applied by transfemoral bone-anchored prostheses fitted with selected ÖSSUR state-of-the-art components. Outcomes suggested that such prostheses can generate relevant loads at the interface with the osseointegrated implant to restore ambulation effectively. This study is a worthwhile contribution toward a systematic recording, analysis, and reporting of ecological prosthetic loading profiles as well as closing the evidence gaps between prescription and biomechanical benefits of state-of-the-art components. Hopefully, this will contribute to improve outcomes for growing number of individuals with limb loss opting for bionic solutions.

Prosthetic push-off power in trans-tibial amputee level ground walking: A systematic review.

OBJECTIVE: Unilateral trans-tibial amputation signifies a challenge to locomotion. Prosthetic ankle-foot units are developed to mimic the missing biological system which adapts push-off power to walking speed in some new prosthetic ankle-foot designs. The first systematic review including the two factors aims to investigate push-off power differences among Solid Ankle Cushion Heel (SACH), Energy Storage And Return (ESAR) and Powered ankle-foot units (PWR) and their relation to walking speed. DATA SOURCES: A literature search was undertaken in the Web of Science, PubMed, IEEE xplore, and Google Scholar databases. The search term included: ampu* AND prosth* AND ankle-power AND push-off AND walking. STUDY APPRAISAL AND SYNTHESIS METHODS: Studies were included if they met the following criteria: unilateral trans-tibial amputees, lower limb prosthesis, reported analysis of ankle power during walking. Data extracted from the included studies were clinical population, type of the prosthetic ankle-foot units (SACH, ESAR, PWR), walking speed, and peak ankle power. Linear regression was used to determine whether the push-off power of different prosthetic ankle-foot units varied regarding walking speed. Push-off power of the different prosthetic ankle-foot units were compared using one-way between subjects' ANOVAs with post hoc analysis, separately for slower and faster walking speeds. RESULTS: 474 publications were retrieved, 28 of which were eligible for inclusion. Correlations between walking speed and peak push-off power were found for ESAR (r = 0.568, p = 0.006) and PWR (r = 0.820, p = 0.000) but not for SACH (r = 0.267, p = 0.522). ESAR and PWR demonstrated significant differences in push-off power for slower and faster walking speeds (ESAR (p = 0.01) and PWR (p = 0.02)). CONCLUSION: Push-off power can be used as a selection criterion to differentiate ankle-foot units for prosthetic users and their bandwidth of walking speeds.

Enhancing functional abilities and cognitive integration of the lower limb prosthesis.

Lower limb amputation (LLA) destroys the sensory communication between the brain and the external world during standing and walking. Current prostheses do not restore sensory feedback to amputees, who, relying on very limited haptic information from the stump-socket interaction, are forced to deal with serious issues: the risk of falls, decreased mobility, prosthesis being perceived as an external object (low embodiment), and increased cognitive burden. Poor mobility is one of the causes of eventual device abandonment. Restoring sensory feedback from the missing leg of above-knee (transfemoral) amputees and integrating the sensory feedback into the sensorimotor loop would markedly improve the life of patients. In this study, we developed a leg neuroprosthesis, which provided real-time tactile and emulated proprioceptive feedback to three transfemoral amputees through nerve stimulation. The feedback was exploited in active tasks, which proved that our approach promoted improved mobility, fall prevention, and agility. We also showed increased embodiment of the lower limb prosthesis (LLP), through phantom leg displacement perception and questionnaires, and ease of the cognitive effort during a dual-task paradigm, through electroencephalographic recordings. Our results demonstrate that induced sensory feedback can be integrated at supraspinal levels to restore functional abilities of the missing leg. This work paves the way for further investigations about how the brain interprets different artificial feedback strategies and for the development of fully implantable sensory-enhanced leg neuroprostheses, which could drastically ameliorate life quality in people with disability.

Sensory feedback restoration in leg amputees improves walking speed, metabolic cost and phantom pain.

Conventional leg prostheses do not convey sensory information about motion or interaction with the ground to above-knee amputees, thereby reducing confidence and walking speed in the users that is associated with high mental and physical fatigue1-4. The lack of physiological feedback from the remaining extremity to the brain also contributes to the generation of phantom limb pain from the missing leg5,6. To determine whether neural sensory feedback restoration addresses these issues, we conducted a study with two transfemoral amputees, implanted with four intraneural stimulation electrodes7 in the remaining tibial nerve (ClinicalTrials.gov identifier NCT03350061). Participants were evaluated while using a neuroprosthetic device consisting of a prosthetic leg equipped with foot and knee sensors. These sensors drive neural stimulation, which elicits sensations of knee motion and the sole of the foot touching the ground. We found that walking speed and self-reported confidence increased while mental and physical fatigue decreased for both participants during neural sensory feedback compared to the no stimulation trials. Furthermore, participants exhibited reduced phantom limb pain with neural sensory feedback. The results from these proof-of-concept cases provide the rationale for larger population studies investigating the clinical utility of neuroprostheses that restore sensory feedback.

Motorized Biomechatronic Upper and Lower Limb Prostheses-Clinically Relevant Outcomes.

People with major limb amputations are severely impaired when it comes to activity, body structure and function, as well as participation. Demographic statistics predict a dramatic increase of this population and additional challenges with their increasing age and higher levels of amputation. Prosthetic use has been shown to have a positive impact on mobility and depression, thereby affecting the quality of life. Biomechatronic prostheses are at the forefront of prosthetic development. Actively powered designs are now regularly used for upper limb prosthetic fittings, whereas for lower limbs the clinical use of actively powered prostheses has been limited to a very low number of applications. Actively powered prostheses enhance restoration of the lost physical functions of an amputee but are yet to allow intuitive user control. This paper provides a review of the status of biomechatronic developments in upper and lower limb prostheses in the context of the various challenges of amputation and the clinically relevant outcomes. Whereas most of the evidence regarding lower limb prostheses addresses biomechanical issues, the evidence for upper limb prostheses relates to activities of daily living (ADL) and instrumental ADL through diverse outcome measures and tools.

The modular socket system in a rural setting in Indonesia.

BACKGROUND: Prosthetic services are inaccessible to people living in rural areas. Systems like the modular socket system have the potential to be fabricated outside of the prosthetic workshop. OBJECTIVES: This study aimed to evaluate the patient's performance and satisfaction with the use of the modular socket system, and the technical feasibility of its implementation in a rural setting. STUDY DESIGN: A quantitative longitudinal descriptive study design was followed. METHODS: A total of 15 persons with a lower limb amputation were fitted with the modular socket system and followed over 4-6 months. Performance was measured using a 2-min walk test, 10-m walk test and mobility and function questionnaire. Satisfaction was measured by the Socket Fit Comfort Score, Prosthesis Evaluation Questionnaire and EuroQoL 5 Dimensions 5 Levels. Notes on technical feasibility were taken at the moment of fitting ( t0), at 1-3 months post fitting ( t1) and at the end evaluation at 4-6 months post fitting ( t2). RESULTS: Performance did not change between t0 and t2. The comfort of the socket fit reduced between t0 and t2. Satisfaction with prosthesis and general health status stayed constant over time. The average fitting-time for the modular socket system was 6.4 h. CONCLUSION: The modular socket system can be considered a useful alternative for use in rural settings. Clinical relevance The use of the modular socket system is feasible and can improve accessibility to prosthetic technology in rural areas. Experienced prosthetic users were satisfied with the performance and the device. The shorter manufacturing time and use of only hand-held tools makes it an ideal alternative for use in remote and rural settings.

Prosthesis donning and doffing questionnaire: Development and validation.

OBJECTIVES: To develop a questionnaire that specifically evaluates the ability of trans-tibial amputees to don and doff a prosthesis and to investigate the psychometric properties of the newly developed questionnaire. BACKGROUND: Prosthesis should be donned and doffed few times during the day and night; thus, it is important to measure ease of donning and doffing. STUDY DESIGN: A cross-sectional study. METHODS: The questionnaire was designed and evaluated by a group of experts. The final questionnaire was administered to 50 individuals with trans-tibial amputation. A test-retest study was also conducted on 20 amputees to assess the repeatability of questionnaire items. RESULTS: The prosthesis donning and doffing questionnaire was developed and tested through a pilot study. Based on Kappa index, the questionnaire items showed correlation coefficients greater than 0.7, which indicate good reliability and repeatability. The majority of the participants had good hand dexterity (80%) and could perform all types of grasps. The mean satisfaction scores with donning and doffing were 69.9 and 81.4, respectively. Most of the respondents needed to don and doff the prosthesis 3.44 times per day. Based on a 7-point score, the total scores ranged between 3 and 7. CONCLUSION: The prosthesis donning and doffing questionnaire items showed good psychometric properties. A scoring method was suggested based on the pilot sample, which requires further evaluation to be able to differentiate between more suspension types. A larger international multicenter evaluation is required in the future to measure the responsiveness of the scales. This questionnaire will be useful in the evaluation of the ability of amputees to don and doff a trans-tibial limb prosthesis. Clinical relevance Donning and doffing of prostheses are challenging tasks for many lower limb amputees. The prosthesis donning and doffing questionnaire, on its own or combined with other prosthetic evaluation questionnaires, has the potential to help manufacturers, clinicians, and researchers gain knowledge and improve the donning and doffing qualities of prostheses.

Assessment of transfemoral amputees using a passive microprocessor-controlled knee versus an active powered microprocessor-controlled knee for level walking.

BACKGROUND: In transfemoral (TF) amputees, the forward propulsion of the prosthetic leg in swing has to be mainly carried out by hip muscles. With hip strength being the strongest predictor to ambulation ability, an active powered knee joint could have a positive influence, lowering hip loading and contributing to ambulation mobility. To assess this, gait of four TF amputees was measured for level walking, first while using a passive microprocessor-controlled prosthetic knee (P-MPK), subsequently while using an active powered microprocessor-controlled prosthetic knee (A-MPK). Furthermore, to assess long-term effects of the use of an A-MPK, a 4-weeks follow-up case study was performed. METHODS: The kinetics and kinematics of the gait of four TF amputees were assessed while walking with subsequently the P-MPK and the A-MPK. For one amputee, a follow-up study was performed: he used the A-MPK for 4 weeks, his gait was measured weekly. RESULTS: The range of motion of the knee was higher on both the prosthetic and the sound leg in the A-MPK compared to the P-MPK. Maximum hip torque (HT) during early stance increased for the prosthetic leg and decreased for the sound leg with the A-MPK compared to the P-MPK. During late stance, the maximum HT decreased for the prosthetic leg. The difference between prosthetic and sound leg for HT disappeared when using the A-MPK. Also, an increase in stance phase duration was observed. The follow-up study showed an increase in confidence with the A-MPK over time. CONCLUSIONS: Results suggested that, partially due to an induced knee flexion during stance, HT can be diminished when walking with the A-MPK compared to the P-MPK. The single case follow-up study showed positive trends indicating that an adaptation time is beneficial for the A-MPK.