Evaluation of functionality-mobility in patients with skeletal dysplasias. Application of the STEMS tool ("everyday symptoms and mobility screening tool for skeletal dysplasias").

Individuals with differing forms of skeletal dysplasias (SD) frequently report impaired mobility and symptoms. With the objetive to evaluate mobility and associated symptoms in people with SD at an Argentinian pediatric hospital, using an Argentinian version of the Screening Tool for Everyday Mobility and Symptoms (STEMS), a simple questionnaire that allows clinicians to quickly identify the presence of symptoms associated with mobility in people with SD, while considering different environmental settings and the use of assistive devices, an analytical study of a consecutive sample of patients older than 5 years with SD and their affected relatives was carried out.Diagnosis, comorbidities, socioenvironmental, therapeutic, auxological and mobility variables were recorded. The presence and intensity of symptoms was noted through use of both the STEMS and validated scales. Descriptive, association and correlation analyzes were performed. One hundred and nineteen individuals with SD were enrolled in the study and divided into groups: Osteogenesis Imperfecta (OI, n = 55), Achondroplasia (ACH, n = 36) and Other SD resulting in disproportionate short stature (n = 28). Mobility assistive devices were almost exclusively used by individuals with OI. They were more frequently used by individuals with overweight and obesity, more severe form of the disease and in the outdoor settings. Two thirds (66.4%) of the individuals assessed in this study reported pain, 87.4% reported fatigue, and 58.8% reported both pain and fatigue. The intensity of symptoms was similar between groups and correlated with age and auxological variables. The STEMS was clear, easy and quick to use for identifying presence of pain and fatigue in this population group. The STEMS proved to be a simple and useful tool for evaluating functional mobility and associated symptoms in our population of individuals with SD.

Implementation of a unilateral hip flexion exosuit to aid paretic limb advancement during inpatient gait retraining for individuals post-stroke: a feasibility study.

BACKGROUND: During inpatient rehabilitation, physical therapists (PTs) often need to manually advance patients' limbs, adding physical burden to PTs and impacting gait retraining quality. Different electromechanical devices alleviate this burden by assisting a patient's limb advancement and supporting their body weight. However, they are less ideal for neuromuscular engagement when patients no longer need body weight support but continue to require assistance with limb advancement as they recover. The objective of this study was to determine the feasibility of using a hip flexion exosuit to aid paretic limb advancement during inpatient rehabilitation post-stroke. METHODS: Fourteen individuals post-stroke received three to seven 1-hour walking sessions with the exosuit over one to two weeks in addition to standard care of inpatient rehabilitation. The exosuit assistance was either triggered by PTs or based on gait events detected by body-worn sensors. We evaluated clinical (distance, speed) and spatiotemporal (cadence, stride length, swing time symmetry) gait measures with and without exosuit assistance during 2-minute and 10-meter walk tests. Sessions were grouped by the assistance required from the PTs (limb advancement and balance support, balance support only, or none) without exosuit assistance. RESULTS: PTs successfully operated the exosuit in 97% of sessions, of which 70% assistance timing was PT-triggered to accommodate atypical gait. Exosuit assistance eliminated the need for manual limb advancement from PTs. In sessions with participants requiring limb advancement and balance support, the average distance and cadence during 2-minute walk test increased with exosuit assistance by 2.2 ± 3.1 m and 3.4 ± 1.9 steps/min, respectively (p < 0.017). In sessions with participants requiring balance support only, the average speed during 10-meter walk test increased with exosuit by 0.07 ± 0.12 m/s (p = 0.042). Clinical and spatiotemporal measures of independent ambulators were similar with and without exosuit (p > 0.339). CONCLUSIONS: We incorporated a unilateral hip flexion exosuit into inpatient stroke rehabilitation in individuals with varying levels of impairments. The exosuit assistance removed the burden of manual limb advancement from the PTs and resulted in improved gait measures in some conditions. Future work will understand how to optimize controller and assistance profiles for this population.

Shoulder arthroplasty in the upper extremity weight-bearing patient: a systematic review of clinical outcomes and complications.

BACKGROUND: Patients who rely on their upper extremities for ambulation, or upper extremity ambulators (UEAs), place considerable stress on their shoulders through the use of assistive devices like walkers, crutches, canes, and wheelchairs. It has been postulated that UEAs may be at increased risk for complications following shoulder arthroplasty. This study aimed to systematically review the literature related to (1) patient-reported outcomes measures (PROMs), (2) functional outcomes, and (3) complications in UEAs who undergo shoulder arthroplasty. METHODS: A systematic review of the PubMed/MEDLINE, Embase, and Cochrane databases was performed to identify studies reporting clinical outcomes of shoulder arthroplasty in UEAs. Patient demographics, clinical characteristics, patient-reported outcomes measures, radiographic outcomes, and postoperative range of motion were collected and compared to control patients (ie bipedal ambulators) from the constituent studies. RESULTS: A total of eight studies evaluating 248 UEA cases and 206 control cases were included for review. Ambulatory assistive devices utilized by UEAs included walkers (39%), wheelchairs (38%), canes (22%), and a crutch (<1%). Among UEA cases, 197 (79%) reverse total shoulder arthroplasty (TSA), 37 (15%) anatomic TSA, and 14 (6%) hemiarthroplasty were performed. Overall, patients exhibited significant improvements in mean American Shoulder and Elbow Surgeons scores, Constant-Murley scores, Simple Shoulder Test scores, and Visual Analog Scale scores postoperatively. Among 3 studies that included comparison with control groups of bipedal ambulators, no significant differences in outcomes were identified. The overall clinical complication rate was 17% for UEAs compared to 9.1% for controls. The rate of revision surgery was 7.7% for UEAs and 4.9% for bipedal ambulators. CONCLUSIONS: UEAs experience satisfactory pain relief, functional improvements, and good subjective outcomes following shoulder arthroplasty. However, complication and revision rates are higher compared to those for bipedal ambulators, and the majority of UEAs undergo reverse shoulder arthroplasty compared to anatomic TSA.

Assistive device utilization among disabled elderly in China: A cross-sectional study.

OBJECTIVE: This study aimed to examine the characteristics of assistive device users and influencing factors among disabled elderly in China. METHODS: A total of 13,510 disabled elderly in Sichuan Province were surveyed. Disability was assessed using the Barthel Activities of Daily Living Scale, mental status, sensory perception, and social engagement evaluation. Univariate analysis and logistic regression analysis were employed to identify the impact factors. RESULTS: The prevalence of assistive device utilization among participants was 79.2% (10,700/13,510, 95% CI 78.5%-79.9%), with the wheelchair being the most commonly used device. Various factors were found to influence the usage of the device, including disability level, somatic disability, age, caregivers, income, caregiver fees, and living situation (p < .05). Additionally, several factors were identified associated with the frequency of device usage, such as somatic disability, education background, income, caregiver fees, living situation, access to acquire assistive devices, duration of assistive device usage, education on assistive devices, and satisfaction level (p < .05). CONCLUSIONS: The use of assistive devices among elderly individuals in China is prevalent. There are many factors that affect the use of assistive devices, which can provide a reference for the formulation of policies in the field of assistive devices.

The impact of an active and passive industrial back exoskeleton on functional performance.

Due to differences in actuation and design, active and passive industrial back exoskeletons could influence functional performance, i.e., work performance, perceived task difficulty, and discomfort, differently. Therefore, this study investigated and compared the impact of the active CrayX (7 kg) and passive Paexo Back (4.5 kg) on functional performance. Eighteen participants performed twelve work-related tasks with both types of exoskeletons and without (NoExo). The CrayX hindered work performance up to 22% in multiple tasks, compared to the Paexo Back and NoExo, while work performance between NoExo and the Paexo Back condition was more comparable, except for stair climbing (13% hindrance). Perceived task difficulty and discomfort seldomly varied between both exoskeletons. Although the CrayX shows promise to benefit workers, limitations in hindrance and comfort should first be addressed. The Paexo Back has demonstrated an advantage in certain static tasks. However, increasing its potential across a broader range of tasks seems warranted.Practitioner Summary: Differences between industrial back exoskeletons with regard to functional performance, i.e. work performance, discomfort and perceived task difficulty, were investigated by evaluating the active CrayX and passive Paexo Back back exoskeletons. The CrayX significantly hindered functional performance, while the Paexo Back seldomly affected functional performance.Abbreviations: WMSD: Work-related musculoskeletal disorder; NoExo: No Exoskeleton; GD: General discomfort; PTD: Perceived task difficulty; BMI: Body Mass Index.

The-state-of-the-art of soft robotics to assist mobility: a review of physiotherapist and patient identified limitations of current lower-limb exoskeletons and the potential soft-robotic solutions.

BACKGROUND: Soft, wearable, powered exoskeletons are novel devices that may assist rehabilitation, allowing users to walk further or carry out activities of daily living. However, soft robotic exoskeletons, and the more commonly used rigid exoskeletons, are not widely adopted clinically. The available evidence highlights a disconnect between the needs of exoskeleton users and the engineers designing devices. This review aimed to explore the literature on physiotherapist and patient perspectives of the longer-standing, and therefore greater evidenced, rigid exoskeleton limitations. It then offered potential solutions to these limitations, including soft robotics, from an engineering standpoint. METHODS: A state-of-the-art review was carried out which included both qualitative and quantitative research papers regarding patient and/or physiotherapist perspectives of rigid exoskeletons. Papers were themed and themes formed the review's framework. RESULTS: Six main themes regarding the limitations of soft exoskeletons were important to physiotherapists and patients: safety; a one-size-fits approach; ease of device use; weight and placement of device; cost of device; and, specific to patients only, appearance of the device. Potential soft-robotics solutions to address these limitations were offered, including compliant actuators, sensors, suit attachments fitting to user's body, and the use of control algorithms. CONCLUSIONS: It is evident that current exoskeletons are not meeting the needs of their users. Solutions to the limitations offered may inform device development. However, the solutions are not infallible and thus further research and development is required.

A bidirectional fabric-based soft robotic glove for hand function assistance in patients with chronic stroke.

BACKGROUND: Chronic stroke patients usually experience reduced hand functions, impeding their ability to perform activities of daily living (ADLs) independently. Additionally, improvements in hand functions by physical therapy beyond six months after the initial onset of stroke are much slower than in the earlier months. As such, chronic stroke patients could benefit from an assistive device to enhance their hand functions, allowing them to perform ADLs independently daily. In recent years, soft robotics has provided a novel approach to assistive devices for motor impaired individuals, offering more compliant and lightweight alternatives to traditional robotic devices. The scope of this study is to demonstrate the viability of a fabric-based soft robotic (SR) glove with bidirectional actuators in assisting chronic stroke study participants with hand impairments in performing ADLs. METHODS: Force and torque measurement tests were conducted to characterize the SR Glove, and hand functional tasks were given to eight chronic stroke patients to assess the efficacy of the SR Glove as an assistive device. The tasks involved object manipulation tasks that simulate ADLs, and the series of tasks was done by the participants once without assistance for baseline data, and once while using the SR Glove. A usability questionnaire was also given to each participant after the tasks were done to gain insight into how the SR Glove impacts their confidence and reliance on support while performing ADLs. RESULTS: The SR Glove improved the participants' manipulation of objects in ADL tasks. The difference in mean scores between the unassisted and assisted conditions was significant across all participants. Additionally, the usability questionnaire showed the participants felt more confident and less reliant on support while using the SR Glove to perform ADLs than without the SR Glove. CONCLUSIONS: The results from this study demonstrated that the SR Glove is a viable option to assist hand function in chronic stroke patients who suffer from hand motor impairments.

A Hand-Held Device Presenting Haptic Directional Cues for the Visually Impaired.

Haptic information is essential in everyday activities, especially for visually impaired people in terms of real-world navigation. Since human haptic sensory processing is nonlinear, asymmetric vibrations have been widely studied to create a pulling sensation for the delivery of directional haptic cues. However, the design of an input control signal that generates asymmetric vibrations has not yet been parameterised. In particular, it is unclear how to quantify the asymmetry of the output vibrations to create a better pulling sensation. To better understand the design of an input control signal that generates haptic directional cues, we evaluated the effect of the pulling sensations corresponding to the three adjustable parameters (i.e., delay time, ramp-down step length, and cut-off voltage) in a commonly applied step-ramp input signal. The results of a displacement measurement and a psychophysical experiment demonstrate that when the quantified asymmetry ratio is in a range of 0.3430-0.3508 with an optimised cut-off voltage for our hand-held device, the haptic directional cues are better perceived by participants. Additionally, the results also showed a superior performance in haptic delivery by shear forces than normal forces.

Outdoor Navigation Assistive System Based on Robust and Real-Time Visual-Auditory Substitution Approach.

Blindness affects millions of people worldwide, leading to difficulties in daily travel and a loss of independence due to a lack of spatial information. This article proposes a new navigation aid to help people with severe blindness reach their destination. Blind people are guided by a short 3D spatialised sound that indicates the target point to follow. This sound is combined with other sonified information on potential obstacles in the vicinity. The proposed system is based on inertial sensors, GPS data, and the cartographic knowledge of pedestrian paths to define the trajectory. In addition, visual clues are used to refine the trajectory with ground floor information and obstacle information using a camera to provide 3D spatial information. The proposed method is based on a deep learning approach. The different neural networks used in this approach are evaluated on datasets that regroup navigations from pedestrians' point-of-view. This method achieves low latency and real-time processing without relying on remote connections, instead using a low-power embedded GPU target and a multithreaded approach for video processing, sound generation, and acquisition. This system could significantly improve the quality of life and autonomy of blind people, allowing them to reliably and efficiently navigate in their environment.

Using a Back Exoskeleton During Industrial and Functional Tasks-Effects on Muscle Activity, Posture, Performance, Usability, and Wearer Discomfort in a Laboratory Trial.

OBJECTIVE: To investigate the effect of using a passive back-support exoskeleton (Laevo V2.56) on muscle activity, posture, heart rate, performance, usability, and wearer comfort during a course of three industrial tasks (COU; exoskeleton worn, turned-on), stair climbing test (SCT; exoskeleton worn, turned-off), timed-up-and-go test (TUG; exoskeleton worn, turned-off) compared to no exoskeleton. BACKGROUND: Back-support exoskeletons have the potential to reduce work-related physical demands. METHODS: Thirty-six men participated. Activity of erector spinae (ES), biceps femoris (BF), rectus abdominis (RA), vastus lateralis (VL), gastrocnemius medialis (GM), trapezius descendens (TD) was recorded by electromyography; posture by trunk, hip, knee flexion angles; heart rate by electrocardiography; performance by time-to-task accomplishment (s) and perceived task difficulty (100-mm visual analogue scale; VAS); usability by the System Usability Scale (SUS) and all items belonging to domains skepticism and user-friendliness of the Technology Usage Inventory; wearer comfort by the 100-mm VAS. RESULTS: During parts of COU, using the exoskeleton decreased ES and BF activity and trunk flexion, and increased RA, GM, and TD activity, knee and hip flexion. Wearing the exoskeleton increased time-to-task accomplishment of SCT, TUG, and COU and perceived difficulty of SCT and TUG. Average SUS was 75.4, skepticism 11.5/28.0, user-friendliness 18.0/21.0, wearer comfort 31.1 mm. CONCLUSION: Using the exoskeleton modified muscle activity and posture depending on the task applied, slightly impaired performance, and was evaluated mildly uncomfortable. APPLICATION: These outcomes require investigating the effects of this passive back-supporting exoskeleton in longitudinal studies with longer operating times, providing better insights for guiding their application in real work settings.

A Statistical Parametric Mapping Analysis Approach for the Evaluation of a Passive Back Support Exoskeleton on Mechanical Loading During a Simulated Patient Transfer Task.

This study assessed the effectiveness of a passive back support exoskeleton during a mechanical loading task. Fifteen healthy participants performed a simulated patient transfer task while wearing the Laevo (version 2.5) passive back support exoskeleton. Collected metrics encompassed L5-S1 joint moments, back and abdominal muscle activity, lower body and back kinematics, center of mass displacement, and movement smoothness. A statistical parametric mapping analysis approach was used to overcome limitations from discretization of continuous data. The exoskeleton reduced L5-S1 joint moments during trunk flexion, but wearing the device restricted L5-S1 joint flexion when flexing the trunk as well as hip and knee extension, preventing participants from standing fully upright. Moreover, wearing the device limited center of mass motion in the caudal direction and increased its motion in the anterior direction. Therefore, wearing the exoskeleton partly reduced lower back moments during the lowering phase of the patient transfer task, but there were some undesired effects such as altered joint kinematics and center of mass displacement. Statistical parametric mapping analysis was useful in determining the benefits and hindrances produced by wearing the exoskeleton while performing the simulated patient transfer task and should be utilized in further studies to inform design and appropriate usage.

Spine-like Joint Link Mechanism to Design Wearable Assistive Devices.

When we develop wearable assistive devices, comfort and support are two main issues that need to be considered. In conventional design approaches, the degree of freedom of the wearer's joint movements tends to be oversimplified. Accordingly, the wearer's motion becomes restrained and bone/ligament injuries might occur in case of an unexpected fall. To mitigate these issues, this paper proposes a novel joint link mechanism inspired by a human spine structure as well as functionalities. The key feature of the proposed spine-like joint link mechanism is that hemispherical blocks are concatenated via flexible synthetic fiber lines so that their concatenation stiffness can be adjusted according to a tensile force. This feature has a great potentiality for designing a wearable assistive device that can support aged people's sit-to-stand action or augment spinal motion by regulating the concatenation stiffness. In addition, the concatenated hemispherical blocks enable the wearer to move his/her joint with full freedom, which in turn increases the wearer's mobility and prevents joint misalignment. The experimental results with a testbed and a pilot wearer substantiated that the spine-like joint link mechanism can serve as a key component in the design of wearable assistive devices for better mobility.

Postural Control When Using an Industrial Lower Limb Exoskeleton: Impact of Reaching for a Working Tool and External Perturbation.

OBJECTIVE: To investigate postural control related to a lower limb exoskeleton (Chairless Chair) when (a) reaching for a working tool, and (b) an external perturbation occurs. BACKGROUND: Lower limb exoskeletons aiming to reduce physical load associated with prolonged standing may impair workers' postural control and increase the risk of falling. METHOD: Forty-five males were reaching for an object (3-kg dumbbell) at the lateral end of their reaching area without the exoskeleton in upright standing (STAND) and with the exoskeleton at a high (EXOHIGH.SEAT) and low sitting position (EXOLOW.SEAT). The task was performed with the object placed in three different angles (120°, 150°, and 180°) in the transversal plane. The minimum absolute static postural stability (SSABS.MIN) as the shortest distance (mm) of the center of pressure to the base of support border was measured (zero indicates risk of falling). Additionally, eight subjects were standing without the exoskeleton or sitting on it (EXOHIGH.SEAT and EXOLOW.SEAT) while being pulled backward. The tilting moment when subjects lost their balance was assessed. RESULTS: SSABS.MIN was lower when using the exoskeleton (p < .05) but still about 17 mm. The location of the object to be reached had no influence. Tilting moments of less than 30 nm were sufficient to let people fall backward when sitting on the exoskeleton (50 nm for STAND). CONCLUSION: Impairments in postural control by the exoskeleton may not be relevant when reaching laterally for objects up to 3 kg. When an external perturbation occurs, the risk of falling may be much higher; irrespective of factors like uneven or slippery flooring. APPLICATION: The risk of falling using the exoskeleton seems to be low when reaching laterally for an object of up to 3 kg. In situations where, for example, a collision with coworkers is likely, this exoskeleton is not recommended.

Using a Passive Back Exoskeleton During a Simulated Sorting Task: Influence on Muscle Activity, Posture, and Heart Rate.

OBJECTIVE: To evaluate using a back exoskeleton in a simulated sorting task in a static forward bent trunk posture on muscle activity, posture, and heart rate (HR). BACKGROUND: Potentials of exoskeletons for reducing musculoskeletal demands in work tasks need to be clarified. METHODS: Thirty-six healthy males performed the sorting task in 40°-forward bent static trunk posture for 90 seconds, in three trunk orientations, with and without exoskeleton. Muscle activity of the erector spinae (ES), biceps femoris (BF), trapezius descendens (TD), rectus abdominis (RA), vastus laterals (VL), and gastrocnemius medialis was recorded using surface electromyography normalized to a submaximal or maximal reference electrical activity (%RVE (reference voluntary electrical activity)/%MVE). Spine and lower limb postures were assessed by gravimetric position sensors, and HR by electrocardiography. RESULTS: Using the exoskeleton resulted in decreased BF muscle activity [-8.12%RVE], and minor changes in ES [-1.29%MVE], RA [-0.28%RVE], VL [-0.49%RVE], and TD [+1.13%RVE] muscle activity. Hip and knee flexion increased [+8.1°; +6.7°]. Heart rate decreased by 2.1 bpm. Trunk orientation had an influence on BF muscle activity. CONCLUSION: Using the back exoskeleton in a short sorting task with static trunk posture mainly reduced hip extensor muscle activity and changed lower limb but not spine posture. Implications of using a back exoskeleton for workers' musculoskeletal health need further clarification. APPLICATION: The detected changes by using the Laevo® illustrate the need for further investigation prior to practical recommendations of using exoskeletons in the field. Investigating various work scenarios in different kind of workers and long-term applications would be important elements.

Effect of upper extremity load on pelvic movements during wheeled upright walker use.

[Purpose] This study aimed to elucidate the effects of upper extremity loading on pelvic movements during wheeled upright walker use. [Participants and Methods] Thirteen healthy male adults participated in this intervention study. Participants walked under five conditions with targeted loads on their upper extremities of 0%, 10%, 20%, 30%, and 40% of their body weights using a wheeled upright walker with armrests. Measured items included gait velocity and stride length; the angle of the maximum trunk anterior tilt; the range of motion of the trunk and pelvis in the movements of obliquity, tilt, and rotation; and the amplitude of the center of mass in the vertical and lateral directions captured and calculated using a three-dimensional motion analysis system. [Results] Increasing the load on the upper extremities did not shorten the stride or restrict pelvic movement during gait using upright walker use. The range of pelvic rotation with walker use increased versus that of the standard gait. [Conclusion] The pelvis showed quantitative movements during gait using the wheeled upright walker with armrests. These results could be helpful in the development of robotic assistive devices.

Digital personal assistants are smart ways for assistive technology to aid the health and wellbeing of patients and carers.

BACKGROUND: Digital health solutions such as assistive technologies create significant opportunities to optimise the effectiveness of both health and social care delivery. Assistive technologies include 'low-tech' items, such as memory aids and digital calendars or 'high-tech' items, like health tracking devices and wearables. Depending on the type of assistive devices, they can be used to improve quality of life, effect lifestyle improvements and increase levels of independence. Acceptance of technology among patients and carers depends on various factors such as perceived skills and competencies in using the device, expectations, trust and reliability. This service evaluation explored the impact of a pilot service redesign focused on improving health and wellbeing by the use of a voice-activated device 'smart speaker', Alexa Echo Show 8. METHODS: A service evaluation/market research was conducted for a pilot service redesign programme. Data were collected via a survey in person or telephone and from two focus groups of patients (n = 44) and informal carers (n = 7). The age of the study participants ranged from 50 to 90 years. Also, the participants belonged to two types of cohort: one specifically focused on diabetes and the other on a range of long-term health conditions such as multiple sclerosis, dementia, depression and others. RESULTS: The device had a positive impact on the health and social well-being of the users; many direct and indirect benefits were identified. Both patients and carers had positive attitudes towards using the device. Self-reported benefits included: reminders for medications and appointments improved adherence and disease control; increased independence and productivity; and for those living alone, the device helped combat their loneliness and low mood. CONCLUSION: The findings from the study help to realise the potential of assistive technology for empowering supporting health/social care. Especially, the season of COVID-19 pandemic has highlighted the need for remote management of health, the use of assistive technology could have a pivotal role to play with the sustainability of health/social care provision by promoting shared care between the care provider and service user. Further evaluation can explore the key drivers and barriers for implementing assistive technologies, especially in people who are ageing and with long-term health conditions.

The ethics of explantation.

BACKGROUND: With the increased use of implanted medical devices follows a large number of explantations. Implants are removed for a wide range of reasons, including manufacturing defects, recovery making the device unnecessary, battery depletion, availability of new and better models, and patients asking for a removal. Explantation gives rise to a wide range of ethical issues, but the discussion of these problems is scattered over many clinical disciplines. METHODS: Information from multiple clinical disciplines was synthesized and analysed in order to provide a comprehensive approach to the ethical issues involved in the explantation of medical implants. RESULTS: Discussions and recommendations are offered on pre-implantation information about a possible future explantation, risk-benefit assessments of explantation, elective explantations demanded by the patient, explantation of implants inserted for a clinical trial, patient registers, quality assurance, routines for investigating explanted implants, and demands on manufacturers to prioritize increased service time in battery-driven implants and to market fewer but more thoroughly tested models of implants. CONCLUSION: Special emphasis is given to the issue of control or ownership over implants, which underlies many of the ethical problems concerning explantation. It is proposed that just like transplants, implants that fulfil functions normally carried out by biological organs should be counted as supplemented body parts. This means that the patient has a strong and inalienable right to the implant, but upon explantation it loses that status.

User-centred assistive SystEm for arm Functions in neUromuscuLar subjects (USEFUL): a randomized controlled study.

BACKGROUND: Upper limb assistive devices can compensate for muscular weakness and empower the user in the execution of daily activities. Multiple devices have been recently proposed but there is still a lack in the scientific comparison of their efficacy. METHODS: We conducted a cross-over multi-centric randomized controlled trial to assess the functional improvement at the upper limb level of two arms supports on 36 patients with muscular dystrophy. Participants tested a passive device (i.e., Wrex by Jaeco) and a semi-active solution for gravity compensation (i.e., Armon Ayura). We evaluated devices' effectiveness with an externally-assessed scale (i.e., Performance of the Upper Limb-PUL-module), a self-perceived scale (i.e., Abilhand questionnaire), and a usability scale (i.e., System Usability Scale). Friedman's test was used to assess significant functional gain for PUL module and Abilhand questionnaire. Moreover, PUL changes were compared by means of the Friedman's test. RESULTS: Most of the patients improved upper limb function with the use of arm supports (median PUL scores increase of 1-3 points). However, the effectiveness of each device was related to the level of residual ability of the end-user. Slightly impaired patients maintained the same independence without and with assistive devices, even if they reported reduced muscular fatigue for both devices. Moderately impaired patients enhanced their arm functionality with both devices, and they obtained higher improvements with the semi-active one (median PUL scores increase of 9 points). Finally, severely impaired subjects benefited only from the semi-active device (median PUL scores increase of 12 points). Inadequate strength was recognized as a barrier to passive devices. The usability, measured by the System Usability Scale, was evaluated by end-users "good" (70/100 points) for the passive, and "excellent" (80/100 points) for the semi-active device. CONCLUSIONS: This study demonstrated that assistive devices can improve the quality of life of people suffering from muscular dystrophy. The use of passive devices, despite being low cost and easy to use, shows limitations in the efficacy of the assistance to daily tasks, limiting the assistance to a predefined horizontal plane. The addition of one active degree of freedom improves efficacy and usability especially for medium to severe patients. Further investigations are needed to increase the evidence on the effect of arm supports on quality of life and diseases' progression in subjects with degenerative disorders. Trial registration clinicaltrials.gov, NCT03127241, Registered 25th April 2017. The clinical trial was also registered as a post-market study at the Italian Ministry of Health.

Reducing the energy cost of running using a lightweight, low-profile elastic exosuit.

BACKGROUND: Human beings can enhance their distance running performance with the help of assistive devices. Although several such devices are available, they are heavy and bulky, which limits their use in everyday activities. In this study, we developed a lightweight running assistive device with a low-profile design. The device applies a flexion moment to the hip according to the hip extension within a specific range of motion to assist running. METHODS: A passive exosuit was fabricated using textile materials and elastic bands. The deformation of the suit was measured and compensated for in the design. The fabricated suit was tested on eight participants (age: 24.4 ± 3.8 y; height: 1.72 ± 0.05 m; weight: 74.5 ± 6.1 kg) who were instructed to run on a treadmill at a speed of 2.5 m/s. Through indirect calorimetry, the metabolic rate was measured for the no-suit condition and three band conditions. Variations in the spatiotemporal parameters were measured using a motion capture system and force-sensing resistors (FSRs). RESULTS: When using the fabricated device, seven out of the eight participants exhibited a reduced metabolic rate in at least one of the three band conditions. An average reduction of - 4.7 ± 1.4% (mean ± standard error of the mean (s.e.m.), two-sided paired t-test, p = 0.017) was achieved when using the best-fitting bands compared to the average of the two no-suit conditions. No statistically significant changes were observed in the spatiotemporal parameters, except for the stance duration in the medium assistance force condition. CONCLUSIONS: The proposed passive exosuit, which has a low weight of 609 g and small extrusion of 2.5 cm from the body in standing posture, can reduce the metabolic rate during running. The proposed device can potentially be used every day owing to its low-profile design and low weight, thereby overcoming the limitations of existing portable devices targeting the hip joints.

Using a simple rope-pulley system that mechanically couples the arms, legs, and treadmill reduces the metabolic cost of walking.

BACKGROUND: Emphasizing the active use of the arms and coordinating them with the stepping motion of the legs may promote walking recovery in patients with impaired lower limb function. Yet, most approaches use seated devices to allow coupled arm and leg movements. To provide an option during treadmill walking, we designed a rope-pulley system that physically links the arms and legs. This arm-leg pulley system was grounded to the floor and made of commercially available slotted square tubing, solid strut channels, and low-friction pulleys that allowed us to use a rope to connect the subject's wrist to the ipsilateral foot. This set-up was based on our idea that during walking the arm could generate an assistive force during arm swing retraction and, therefore, aid in leg swing. METHODS: To test this idea, we compared the mechanical, muscular, and metabolic effects between normal walking and walking with the arm-leg pulley system. We measured rope and ground reaction forces, electromyographic signals of key arm and leg muscles, and rates of metabolic energy consumption while healthy, young subjects walked at 1.25 m/s on a dual-belt instrumented treadmill (n = 8). RESULTS: With our arm-leg pulley system, we found that an assistive force could be generated, reaching peak values of 7% body weight on average. Contrary to our expectation, the force mainly coincided with the propulsive phase of walking and not leg swing. Our findings suggest that subjects actively used their arms to harness the energy from the moving treadmill belt, which helped to propel the whole body via the arm-leg rope linkage. This effectively decreased the muscular and mechanical demands placed on the legs, reducing the propulsive impulse by 43% (p < 0.001), which led to a 17% net reduction in the metabolic power required for walking (p = 0.001). CONCLUSIONS: These findings provide the biomechanical and energetic basis for how we might reimagine the use of the arms in gait rehabilitation, opening the opportunity to explore if such a method could help patients regain their walking ability. TRIAL REGISTRATION: Study registered on 09/29/2018 in ClinicalTrials.gov (ID-NCT03689647).