Relevance of hazards in exoskeleton applications: a survey-based enquiry.

Exoskeletons are becoming the reference technology for assistance and augmentation of human motor functions in a wide range of application domains. Unfortunately, the exponential growth of this sector has not been accompanied by a rigorous risk assessment (RA) process, which is necessary to identify the major aspects concerning the safety and impact of this new technology on humans. This situation may seriously hamper the market uptake of new products. This paper presents the results of a survey that was circulated to understand how hazards are considered by exoskeleton users, from research and industry perspectives. Our analysis aimed to identify the perceived occurrence and the impact of a sample of generic hazards, as well as to collect suggestions and general opinions from the respondents that can serve as a reference for more targeted RA. Our results identified a list of relevant hazards for exoskeletons. Among them, misalignments and unintended device motion were perceived as key aspects for exoskeletons' safety. This survey aims to represent a first attempt in recording overall feedback from the community and contribute to future RAs and the identification of better mitigation strategies in the field.

Detection thresholds for electrostimulation combined with robotic leg support in sub-acute stroke patients.

Stroke is one of the leading causes of disability in adults in the European Union. It often leads to motor impairments, such as a hemiparetic lower extremity. Research indicates that early task-specific and intensive training promotes neuroplasticity and leads to recovery and/or compensation. One way to provide intensive training early after a stroke is via robot-supported training. A rehabilitation robot was designed by Life Science Robotics (Aalborg, Denmark) that can provide continuous repetitive movements of the hip, knee, and/or ankle in e.g., a lying position. In order to emphasize active contribution by the patient, actively triggered electrical stimulation (via muscle activation) can be combined with robotic assistance. The current study aims to compare different threshold estimation methods for detection of movement intention from muscle activity for actively triggered electrical stimulation during robot-supported leg movement in stroke patients. Three sub-acute stroke patients were included for a single measurement session. They performed knee extension and/or ankle dorsal flexion with four different threshold estimation methods to assess the intention detection threshold to initiate electrostimulation. The thresholds were based on the resting level of muscle activity (of m. rectus femoris or m. tibialis anterior) plus two or three times the standard deviation of the average resting value, or the resting level plus 5% or 10% of the peak muscle activity during a maximal voluntary contraction. The results showed that the method based on the resting muscle activity plus two times the standard deviation was the most stable across the three included stroke patients. This method had a detection success rate of 86.7% and was experienced as moderately comfortable. In conclusion, performing knee extension and/or ankle dorsal flexion with electromyography triggered electrostimulation is feasible in sub-acute stroke patients. Muscle activity-triggered electrostimulation combined with robotic support based on a threshold of resting levels plus two times the standard deviation seems to detect movement initiation most consistently in this small sample of sub-acute stroke patients.

Effect on Hand Function After Six-week Use of a Wearable Soft-Robotic Glove Assisting ADL: Interim Results of an Ongoing Clinical Study.

In an ongoing study, an assistive wearable soft-robotic glove is tested at home for 6 weeks by subjects with decreased handgrip strength, due to different hand injuries or diseases, to assess whether use of this assistive grip-supporting glove will result in improved hand strength/ function. An interim analysis of the available dataset of 46 participants showed that (unsupported) grip strength and hand function improved after using the soft-robotic glove as assistive aid during activities of daily living (ADLs) during 6 weeks at home. After glove use is ended, this is maintained for at least 4 weeks. Considering that in the current situation the analysis is underpowered, these interim results are promising for finding a clinical (therapeutic) effect of using a soft-robotic glove as assistance during ADLs. If this is the case, this might open up entirely new opportunities for extending rehabilitation into people's homes, while also providing them with assistance to directly support performance of daily activities. Such a combination is becoming available with the development of mature and user-friendly wearable soft-robotic devices. This would enable very high doses of training throughout the day, in the most functional, task-specific way possible, and possibly prevention of learned non-use.

Therapeutic Effect of a Soft Robotic Glove for Activities of Daily Living In People With Impaired Hand Strength: Protocol for a Multicenter Clinical Trial (iHand).

BACKGROUND: Decline of hand function, especially reduced hand strength, is a common problem that can be caused by many disorders and results in difficulties performing activities of daily living. A wearable soft robotic glove may be a solution, enabling use of the affected arm and hand repeatedly during functional daily activities and providing intensive and task-specific training simultaneously with assistance of hand function. OBJECTIVE: We aim to investigate the therapeutic effect of an assistive soft robotic glove (Carbonhand). METHODS: This multicenter uncontrolled intervention study consists of 3 preassessments (T0, T1, and T2), a postassessment (T3), and a follow-up assessment (T4). Participants are patients who experience hand function limitations. For the intervention, participants will use the glove during activities of daily living at home for 6 weeks, with a recommended use of at least 180 minutes per week. The primary outcome measure is handgrip strength, and secondary outcome measures are related to functional arm and hand abilities, amount of glove use, and quality of life. RESULTS: The first participant was included on June 25, 2019. Currently, the study has been extended due to the COVID-19 pandemic; data collection and analysis are expected to be completed in 2022. CONCLUSIONS: The Carbonhand system is a wearable assistive device, allowing performance of functional activities to be enhanced directly during functional daily activities. At the same time, active movement of the user is encouraged as much as possible, which has potential to provide highly intensive and task-specific training. As such, it is one of the first assistive devices to incorporate assist-as-needed principles. This is the first powered clinical trial that investigates the unique application of an assistive grip-supporting soft robotic glove outside of clinical settings with the aim to have a therapeutic effect. TRIAL REGISTRATION: Netherlands Trial Register NTR NL7561; https://www.trialregister.nl/trial/7561. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34200.

Assessing effects of exoskeleton misalignment on knee joint load during swing using an instrumented leg simulator.

BACKGROUND: Exoskeletons are working in parallel to the human body and can support human movement by exerting forces through cuffs or straps. They are prone to misalignments caused by simplified joint mechanics and incorrect fit or positioning. Those misalignments are a common safety concern as they can cause undesired interaction forces. However, the exact mechanisms and effects of misalignments on the joint load are not yet known. The aim of this study was therefore to investigate the influence of different directions and magnitudes of exoskeleton misalignment on the internal knee joint forces and torques of an artificial leg. METHODS: An instrumented leg simulator was used to quantify the changes in knee joint load during the swing phase caused by misalignments of a passive knee brace being manually flexed. This was achieved by an experimenter pulling on a rope attached to the distal end of the knee brace to create a flexion torque. The extension was not actuated but achieved through the weight of the instrumented leg simulator. The investigated types of misalignments are a rotation of the brace around the vertical axis and a translation in anteroposterior as well as proximal/distal direction. RESULTS: The amount of misalignment had a significant effect on several directions of knee joint load in the instrumented leg simulator. In general, load on the knee joint increased with increasing misalignment. Specifically, stronger rotational misalignment led to higher forces in mediolateral direction in the knee joint as well as higher ab-/adduction, flexion and internal/external rotation torques. Stronger anteroposterior translational misalignment led to higher mediolateral knee forces as well as higher abduction and flexion/extension torques. Stronger proximal/distal translational misalignment led to higher posterior and tension/compression forces. CONCLUSIONS: Misalignments of a lower leg exoskeleton can increase internal knee forces and torques during swing to a multiple of those experienced in a well-aligned situation. Despite only taking swing into account, this is supporting the need for carefully considering hazards associated with not only translational but also rotational misalignments during wearable robot development and use. Also, this warrants investigation of misalignment effects in stance, as a target of many exoskeleton applications.

European evidence-based recommendations for clinical assessment of upper limb in neurorehabilitation (CAULIN): data synthesis from systematic reviews, clinical practice guidelines and expert consensus.

BACKGROUND: Technology-supported rehabilitation can help alleviate the increasing need for cost-effective rehabilitation of neurological conditions, but use in clinical practice remains limited. Agreement on a core set of reliable, valid and accessible outcome measures to assess rehabilitation outcomes is needed to generate strong evidence about effectiveness of rehabilitation approaches, including technologies. This paper collates and synthesizes a core set from multiple sources; combining existing evidence, clinical practice guidelines and expert consensus into European recommendations for Clinical Assessment of Upper Limb In Neurorehabilitation (CAULIN). METHODS: Data from systematic reviews, clinical practice guidelines and expert consensus (Delphi methodology) were systematically extracted and synthesized using strength of evidence rating criteria, in addition to recommendations on assessment procedures. Three sets were defined: a core set: strong evidence for validity, reliability, responsiveness and clinical utility AND recommended by at least two sources; an extended set: strong evidence OR recommended by at least two sources and a supplementary set: some evidence OR recommended by at least one of the sources. RESULTS: In total, 12 measures (with primary focus on stroke) were included, encompassing body function and activity level of the International Classification of Functioning and Health. The core set recommended for clinical practice and research: Fugl-Meyer Assessment of Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT); the extended set recommended for clinical practice and/or clinical research: kinematic measures, Box and Block Test (BBT), Chedoke Arm Hand Activity Inventory (CAHAI), Wolf Motor Function Test (WMFT), Nine Hole Peg Test (NHPT) and ABILHAND; the supplementary set recommended for research or specific occasions: Motricity Index (MI); Chedoke-McMaster Stroke Assessment (CMSA), Stroke Rehabilitation Assessment Movement (STREAM), Frenchay Arm Test (FAT), Motor Assessment Scale (MAS) and body-worn movement sensors. Assessments should be conducted at pre-defined regular intervals by trained personnel. Global measures should be applied within 24 h of hospital admission and upper limb specific measures within 1 week. CONCLUSIONS: The CAULIN recommendations for outcome measures and assessment procedures provide a clear, simple, evidence-based three-level structure for upper limb assessment in neurological rehabilitation. Widespread adoption and sustained use will improve quality of clinical practice and facilitate meta-analysis, critical for the advancement of technology-supported neurorehabilitation.

Safety Assessment of Rehabilitation Robots: A Review Identifying Safety Skills and Current Knowledge Gaps.

The assessment of rehabilitation robot safety is a vital aspect of the development process, which is often experienced as difficult. There are gaps in best practices and knowledge to ensure safe usage of rehabilitation robots. Currently, safety is commonly assessed by monitoring adverse events occurrence. The aim of this article is to explore how safety of rehabilitation robots can be assessed early in the development phase, before they are used with patients. We are suggesting a uniform approach for safety validation of robots closely interacting with humans, based on safety skills and validation protocols. Safety skills are an abstract representation of the ability of a robot to reduce a specific risk or deal with a specific hazard. They can be implemented in various ways, depending on the application requirements, which enables the use of a single safety skill across a wide range of applications and domains. Safety validation protocols have been developed that correspond to these skills and consider domain-specific conditions. This gives robot users and developers concise testing procedures to prove the mechanical safety of their robotic system, even when the applications are in domains with a lack of standards and best practices such as the healthcare domain. Based on knowledge about adverse events occurring in rehabilitation robot use, we identified multi-directional excessive forces on the soft tissue level and musculoskeletal level as most relevant hazards for rehabilitation robots and related them to four safety skills, providing a concrete starting point for safety assessment of rehabilitation robots. We further identified a number of gaps which need to be addressed in the future to pave the way for more comprehensive guidelines for rehabilitation robot safety assessments. Predominantly, besides new developments of safety by design features, there is a strong need for reliable measurement methods as well as acceptable limit values for human-robot interaction forces both on skin and joint level.

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review.

Robot-assisted gait training (RAGT) devices are used in rehabilitation to improve patients' walking function. While there are some reports on the adverse events (AEs) and associated risks in overground exoskeletons, the risks of stationary gait trainers cannot be accurately assessed. We therefore aimed to collect information on AEs occurring during the use of stationary gait robots and identify associated risks, as well as gaps and needs, for safe use of these devices. We searched both bibliographic and full-text literature databases for peer-reviewed articles describing the outcomes of stationary RAGT and specifically mentioning AEs. We then compiled information on the occurrence and types of AEs and on the quality of AE reporting. Based on this, we analyzed the risks of RAGT in stationary gait robots. We included 50 studies involving 985 subjects and found reports of AEs in 18 of those studies. Many of the AE reports were incomplete or did not include sufficient detail on different aspects, such as severity or patient characteristics, which hinders the precise counts of AE-related information. Over 169 device-related AEs experienced by between 79 and 124 patients were reported. Soft tissue-related AEs occurred most frequently and were mostly reported in end-effector-type devices. Musculoskeletal AEs had the second highest prevalence and occurred mainly in exoskeleton-type devices. We further identified physiological AEs including blood pressure changes that occurred in both exoskeleton-type and end-effector-type devices. Training in stationary gait robots can cause injuries or discomfort to the skin, underlying tissue, and musculoskeletal system, as well as unwanted blood pressure changes. The underlying risks for the most prevalent injury types include excessive pressure and shear at the interface between robot and human (cuffs/harness), as well as increased moments and forces applied to the musculoskeletal system likely caused by misalignments (between joint axes of robot and human). There is a need for more structured and complete recording and dissemination of AEs related to robotic gait training to increase knowledge on risks. With this information, appropriate mitigation strategies can and should be developed and implemented in RAGT devices to increase their safety.

The effect of a wearable soft-robotic glove on motor function and functional performance of older adults.

Reduced grip strength, resulting in difficulties in performing daily activities, is a common problem in the population of older adults. Newly developed soft-robotic devices have the potential to support older adults with reduced grip in daily activities. The objective of this study was to evaluate the direct, assistive effect of grip support from the wearable, soft-robotic ironHand glove.In total, 65 older adults with self-reported decline of hand function resulting from various disorders participated in this cross-sectional study. They performed various hand function tests with and without the glove during a single session. At the end, usability was scored.Participants were able to produce more pinch strength with the glove compared to without glove (p ≤ 0.001) and usability was rated very positively. However, this was not reflected in improved functional performance with the glove, as measured with timed tasks (p < 0.001). Furthermore, no correlation was found between baseline handgrip strength and changes in performance (between without and with glove) of all assessments (ρ ≤ 0.137, p ≥ 0.288).Further design adaptations are desired and more research is needed to investigate if performance with the glove can improve, when taking quality of task performance into account, or when applying a longer acquaintance period with the glove.

Home rehabilitation supported by a wearable soft-robotic device for improving hand function in older adults: A pilot randomized controlled trial.

BACKGROUND: New developments, based on the concept of wearable soft-robotic devices, make it possible to support impaired hand function during the performance of daily activities and intensive task-specific training. The wearable soft-robotic ironHand glove is such a system that supports grip strength during the performance of daily activities and hand training exercises at home. DESIGN: This pilot randomized controlled clinical study explored the effect of prolonged use of the assistive ironHand glove during daily activities at home, in comparison to its use as a trainings tool at home, on functional performance of the hand. METHODS: In total, 91 older adults with self-perceived decline of hand function participated in this study. They were randomly assigned to a 4-weeks intervention of either assistive or therapeutic ironHand use, or control group (received no additional exercise or treatment). All participants performed a maximal pinch grip test, Box and Blocks test (BBT), Jebsen-Taylor Hand Function Test (JTHFT) at baseline and after 4-weeks of intervention. Only participants of the assistive and therapeutic group completed the System Usability Scale (SUS) after the intervention period. RESULTS: Participants of the assistive and therapeutic group reported high scores on the SUS (mean = 73, SEM = 2). The therapeutic group showed improvements in unsupported handgrip strength (mean Δ = 3) and pinch strength (mean Δ = 0.5) after 4 weeks of ironHand use (p≤0.039). Scores on the BBT and JTHFT improved not only after 4 weeks of ironHand use (assistive and therapeutic), but also in the control group. Only handgrip strength improved more in the therapeutic group compared to the assistive and control group. No significant correlations were found between changes in performance and assistive or therapeutic ironHand use (p≥0.062). CONCLUSION: This study showed that support of the wearable soft-robotic ironHand system either as assistive device or as training tool may be a promising way to counter functional hand function decline associated with ageing.

Prototype Measuring Device for Assessing Interaction Forces between Human Limbs and Rehabilitation Robots - A Proof of Concept Study.

Rehabilitation robots can provide high intensity and dosage training or assist patients in activities of daily living and decrease physical strain on clinicians. However, the physical human robot interaction poses a major safety issue, as the close physical contact between user and robot can lead to injuries. Moreover, the magnitude of forces as well as best practices for measuring them, are widely unknown. Therefore, a measurement setup was developed to assess normal and tangential forces that occur in the contact area between an arm and a splint. Force sensitive resistors and a force / torque sensor were combined with two different splint shapes. Initial experiments indicated that the setup gives some insight into magnitudes and distribution of normal forces on the splint-forearm-interface. Experiment results show a dependency of force distributions on the splint shape and sensor locations. Based on these outcomes, we proposed an improved setup for subsequent investigations.

Quantifying upper extremity performance with and without assistance of a soft-robotic glove in elderly patients: A kinematic analysis.

OBJECTIVE: To explore the direct influence of a soft-robotic glove on movement duration and movement execution in elderly people with decreased hand function during a reach-and-grasp task. DESIGN: Cross-sectional study. PATIENTS: Eight subjects, aged 55+ years, with decreased hand function. METHODS: The direct effect of the glove was explored using kinematic analysis during a reach-and-grasp task with a light (100 g) and heavy (1,000/2,500 g) cylindrical object, performed with and without the soft-robotic glove. RESULTS: There was no difference in total movement time between performance with and without the glove. With the glove, the relative time needed to transport the heavy object was shorter, while the relative time needed to grasp the heavy object was longer. In addition, transporting light objects involved a lower peak velocity and larger elbow extension, and grasping the object involved a larger hand opening compared with without glove. CONCLUSION: As expected, no positive influence of the soft-robotic glove was found on total movement duration in elderly subjects. The influence of the glove on movement execution varied with movement phase. The positive and negative effects found may be due to a perceived confidence while carrying heavy objects with the glove, or compensation for loss of sensation, respectively. This information can be used to improve the glove design.

Assistive Technology for the Upper Extremities After Stroke: Systematic Review of Users' Needs.

BACKGROUND: Technical innovations have the potential to compensate for loss of upper-limb motor functions after stroke. However, majority of the designs do not completely meet the needs and preferences of the end users. User-centered design methods have shown that the attention to user perspectives during development of assistive technology leads to devices that better suit the needs of the users. OBJECTIVE: To get more insight into the factors that can bring the design of assistive technology to higher levels of satisfaction and acceptance, studies about user perspectives on assistive technology for the upper limb after stroke are systematically reviewed. METHODS: A database search was conducted in PubMed, EMBASE, CINAHL, PsycINFO, and Scopus from inception to August 2017, supplemented with a search of reference lists. Methodological quality of the included studies was appraised. User perspectives of stroke survivors, carers, and health care professionals were extracted. A total of 35 descriptive themes were identified, from which 5 overarching themes were derived. RESULTS: In total, 9 studies with information gathered from focus groups, questionnaires, and interviews were included. Barriers and enablers influencing the adoption of assistive technology for the upper limb after stroke emerged within 5 overarching but highly interdependent themes: (1) promoting hand and arm performance; (2) attitude toward technology; (3) decision process; (4) usability; and (5) practical applicability. CONCLUSIONS: Expected use of an assistive technology is facilitated when it has a clear therapeutic base (expected benefit in enhancing function), its users (patients and health care professionals) have a positive attitude toward technology, sufficient information about the assistive technology is available, and usability and practical applicability have been addressed successfully in its design. The interdependency of the identified themes implies that all aspects influencing user perspectives of assistive technology need to be considered when developing assistive technology to enhance its chance of acceptance. The importance of each factor may vary depending on personal factors and the use context, either at home as an assistive aid or for rehabilitation at a clinic.

Feasibility of a wearable soft-robotic glove to support impaired hand function in stroke patients.

OBJECTIVE: To investigate the feasibility of a wear-able, soft-robotic glove system developed to combine assistive support in daily life with performing therapeutic exercises on a computer at home (the HandinMind system). DESIGN: Feasibility study. PATIENTS: Five chronic stroke patients with limitations in activities of daily living due to impaired hand function. METHODS: Participants performed a usability test and several functional tasks with the HandinMind system across 2 sessions. Feasibility was measured using the System Usability Scale (SUS), Intrinsic Motivation Inventory (IMI) and performance times of the functional tasks. RESULTS: User acceptance measured by the SUS and IMI was scored high. The median SUS scores of sessions 1 and 2 were 80.0 (interquartile range (IQR) 70.0-88.8) and 77.5 (IQR 75.0-87.5), respectively, and the median IMI score was 6.3 points out of 7 points (IQR 6.2-6.3). Functional task performance was initially slower with the HandinMind glove compared with performance without the glove, but improved up to the level of performance without the glove across no more than 3 repetitions. CONCLUSION: Chronic stroke patients with impaired hand function were positive about the feasibility of the first prototype of the HandinMind system. How-ever, performance and ease of use of the system should be improved further in future development phases.

Strong relations of elbow excursion and grip strength with post-stroke arm function and activities: Should we aim for this in technology-supported training?

OBJECTIVE: To investigate the relationships between an extensive set of objective movement execution kinematics of the upper extremity and clinical outcome measures in chronic stroke patients: at baseline and after technology-supported training at home. METHODS: Twenty mildly to severely affected chronic stroke patients participated in the baseline evaluation, 15 were re-evaluated after six weeks of intensive technology-supported or conventional arm/hand training at home. Grip strength, 3D motion analysis of a reach and grasp task, and clinical scales (Fugl-Meyer assessment (FM), Action Research Arm Test (ARAT) and Motor Activity Log (MAL)) were assessed pre- and post-training. RESULTS: Most movement execution parameters showed moderate-to-strong relationships with FM and ARAT, and to a smaller degree with MAL. Elbow excursion explained the largest amount of variance in FM and ARAT, together with grip strength. The only strong association after training was found between changes in ARAT and improvements in hand opening (conventional) or grip strength (technology-supported). CONCLUSIONS: Elbow excursion and grip strength showed strongest association with post-stroke arm function and activities. Improved functional ability after training at home was associated with increased hand function. Addressing both reaching and hand function are indicated as valuable targets for (technological) treatment applications to stimulate functional improvements after stroke.

Applying a soft-robotic glove as assistive device and training tool with games to support hand function after stroke: Preliminary results on feasibility and potential clinical impact.

Recent technological developments regarding wearable soft-robotic devices extend beyond the current application of rehabilitation robotics and enable unobtrusive support of the arms and hands during daily activities. In this light, the HandinMind (HiM) system was developed, comprising a soft-robotic, grip supporting glove with an added computer gaming environment. The present study aims to gain first insight into the feasibility of clinical application of the HiM system and its potential impact. In order to do so, both the direct influence of the HiM system on hand function as assistive device and its therapeutic potential, of either assistive or therapeutic use, were explored. A pilot randomized clinical trial was combined with a cross-sectional measurement (comparing performance with and without glove) at baseline in 5 chronic stroke patients, to investigate both the direct assistive and potential therapeutic effects of the HiM system. Extended use of the soft-robotic glove as assistive device at home or with dedicated gaming exercises in a clinical setting was applicable and feasible. A positive assistive effect of the soft-robotic glove was proposed for pinch strength and functional task performance 'lifting full cans' in most of the five participants. A potential therapeutic impact was suggested with predominantly improved hand strength in both participants with assistive use, and faster functional task performance in both participants with therapeutic application.

Effects of training with a passive hand orthosis and games at home in chronic stroke: a pilot randomised controlled trial.

OBJECTIVES: To compare user acceptance and arm and hand function changes after technology-supported training at home with conventional exercises in chronic stroke. Secondly, to investigate the relation between training duration and clinical changes. DESIGN: A randomised controlled trial. SETTING: Training at home, evaluation at research institute. SUBJECTS: Twenty chronic stroke patients with severely to mildly impaired arm and hand function. INTERVENTIONS: Participants were randomly assigned to six weeks (30 minutes per day, six days a week) of self-administered home-based arm and hand training using either a passive dynamic wrist and hand orthosis combined with computerised gaming exercises (experimental group) or prescribed conventional exercises from an exercise book (control group). MAIN MEASURES: Main outcome measures are the training duration for user acceptance and the Action Research Arm Test for arm and hand function. Secondary outcomes are the Intrinsic Motivation Inventory, Fugl-Meyer assessment, Motor Activity Log, Stroke Impact Scale and grip strength. RESULTS: The control group reported a higher training duration (189 versus 118 minutes per week, P = 0.025). Perceived motivation was positive and equal between groups ( P = 0.935). No differences in clinical outcomes over training between groups were found (P ⩾ 0.165). Changes in Box and Block Test correlated positively with training duration ( P = 0.001). CONCLUSIONS: Both interventions were accepted. An additional benefit of technology-supported arm and hand training over conventional arm and hand exercises at home was not demonstrated. Training duration in itself is a major contributor to arm and hand function improvements.

Evaluation of upper extremity neurorehabilitation using technology: a European Delphi consensus study within the EU COST Action Network on Robotics for Neurorehabilitation.

BACKGROUND: The need for cost-effective neurorehabilitation is driving investment into technologies for patient assessment and treatment. Translation of these technologies into clinical practice is limited by a paucity of evidence for cost-effectiveness. Methodological issues, including lack of agreement on assessment methods, limit the value of meta-analyses of trials. In this paper we report the consensus reached on assessment protocols and outcome measures for evaluation of the upper extremity in neurorehabilitation using technology. The outcomes of this research will be part of the development of European guidelines. METHODS: A rigorous, systematic and comprehensive modified Delphi study incorporated questions and statements generation, design and piloting of consensus questionnaire and five consensus experts groups consisting of clinicians, clinical researchers, non-clinical researchers, and engineers, all with working experience of neurological assessments or technologies. For data analysis, two major groups were created: i) clinicians (e.g., practicing therapists and medical doctors) and ii) researchers (clinical and non-clinical researchers (e.g. movement scientists, technology developers and engineers). RESULTS: Fifteen questions or statements were identified during an initial ideas generation round, following which the questionnaire was designed and piloted. Subsequently, questions and statements went through five consensus rounds over 20 months in four European countries. Two hundred eight participants: 60 clinicians (29 %), 35 clinical researchers (17 %), 77 non-clinical researchers (37 %) and 35 engineers (17 %) contributed. At each round questions and statements were added and others removed. Consensus (≥69 %) was obtained for 22 statements on i) the perceived importance of recommendations; ii) the purpose of measurement; iii) use of a minimum set of measures; iv) minimum number, timing and duration of assessments; v) use of technology-generated assessments and the restriction of clinical assessments to validated outcome measures except in certain circumstances for research. CONCLUSIONS: Consensus was reached by a large international multidisciplinary expert panel on measures and protocols for assessment of the upper limb in research and clinical practice. Our results will inform the development of best practice for upper extremity assessment using technologies, and the formulation of evidence-based guidelines for the evaluation of upper extremity neurorehabilitation.

A wearable soft-robotic glove enables hand support in ADL and rehabilitation: A feasibility study on the assistive functionality.

BACKGROUND: Elderly people frequently experience a decline in hand function, due to ageing or diseases. This leads to decreased independence in activities of daily living (ADL). Assistive technology may enhance independence. OBJECTIVES: The objective of this paper was to explore user acceptance of an affordable wearable soft-robotic glove (ironHand (iH) system), that supports grip and hand opening in ADL. In addition, functional performance with the iH system was explored. METHODS: For this study 28 elderly people used the iH system across two sessions. During these sessions, participants performed six functional tasks with and without the iH system. Outcome measures were System Usability Scale (SUS), Intrinsic Motivation Inventory (IMI) and performance time of the functional tasks. RESULTS: User acceptance scored highly, with a mean SUS score of at least 63.4 (SD = 19.0) and a mean IMI score of 5.1 points (SD = 0.97 points). Functional task performance improved across repetitions both with and without the glove (p ≤ 0.017), but all functional tasks were performed faster without the glove (p ≤ 0.032). CONCLUSION: Participants perceived the iH system as useful, pleasant and meaningful. The learning curve in functional performance time (improvements across repetitions) is promising, since it suggests there is room for improved performance when a longer acquaintance period is applied.