Development of an assistive soft exoskeleton : a multistakeholder endeavour

Background As in other areas, digitalization and new technologies become increasingly relevant for physiotherapy. However, often these developments are driven by technological feasibility rather than by clinical demand. In order to grant maximum acceptability and effective implementation of a technology multiple stakeholders i.e. engineers, patients and therapists need to collaborate throughout the planning and development processes. Here, we describe the design and development of three prototype-generations of a soft and modular exoskeleton. Purpose Development of a soft and modular exoskeleton, which incorporates the needs and requirements of future users. Methods Nine research groups including therapists, designers and engineers from seven European countries were involved in this project. As stakeholders we considered patients with gait limitations due to stroke, incomplete spinal cord injury or age-related weakness (primary end-users, PU), therapists with professional experience in the area of the PU’s conditions and non-professional carers (secondary end-users, SU). The perspectives of PU and SU were incorporated into the technical concepts adopting a user-centered design approach. The initial prototype was designed according to the requirements, which were derived from use-cases representing the target populations. Evaluations of all prototypes were performed using semi-structured interviews with both, PU and SU. Functions of the respective prototypes were evaluated with a predefined testing protocol. The conclusions of the evaluations were fed back to the engineers and informed the development of the consecutive prototypes. All data collection procedures were approved by the local ethics committee and participants provided written informed consent. Results In total eight PU and eight SU were recruited. In general, the prototypes were in an early stage of development and the operation required staff with engineering knowledge and an experimental laboratory. In general, PU and SU rated the technology positively. The individually analyzed data from the interviews and functionality tests revealed heterogeneous results indicating the diversity of the PU’s functional impairments and expectations of PU and SU. Conclusions Based on this project’s experience, we are convinced that future PU and SU of a technology must be involved in the development from the very beginning. However, in order to obtain adequate feedback, the choice of individuals (PU and SU) and the level of involvement must be considered carefully. For example, inadequate expectations may draw the attention to irrelevant issues. In our project, research physiotherapists played a key role by bridging PU and SU with engineers. This information exchange was partially challenging because of different areas of interest, different terminology and geographical distance. Implications A common understanding of the project goals among the project teams and adherence to timelines are essential for successful progress such a large project. The project should assure that all stakeholders can acquire basic knowledge and perspectives of the other involved stakeholders, especially from other disciplines. Specifically for physiotherapists, basic and continuing education should incorporate technological knowledge from engineering disciplines in order to enable physiotherapists to contribute to the development of new devices. This opens the chance to participate in the development of technology for clinical applications. Funding acknowledgements This work has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 688175 (XoSoft)

Locomotion in stroke subjects: interactions between unaffected and affected sides

The aim of this study was to evaluate the sensorimotor interactions between unaffected and affected sides of post-stroke subjects during locomotion. In healthy subjects, stimulation of the tibial nerve during the mid-stance phase is followed by electromyography responses not only in the ipsilateral tibialis anterior, but also in the proximal arm muscles of both sides, with larger amplitudes prior to swing over an obstacle compared with normal swing. In post-stroke subjects, the electromyography responses were stronger on both sides when the tibial nerve of the unaffected leg was stimulated compared with stimulation of the affected leg. This difference was more pronounced when stimuli were applied prior to swing over an obstacle than prior to normal swing. This indicates an impaired processing of afferent input from the affected leg resulting in attenuated and little task-modulated reflex responses in the arm muscles on both sides. In contrast, an afferent volley from the unaffected leg resulted in larger electromyography responses, even in the muscles of the affected arm. Arm muscle activations were stronger during swing over an obstacle than during normal swing, with no difference in electromyography amplitudes between the unaffected and affected sides. It is concluded that the deficits of the affected arm are compensated for by influences from the unaffected side. These observations indicate strong mutual influences between unaffected and affected sides during locomotion of post-stroke subjects, which might be used to optimize rehabilitation approache

Camelote et objets précieux – vers une évaluation de la qualité des applications et «wearables» en physiothérapie

Mobile Anwendungen gewinnen auch in therapeutischen Berufen an Popularität. Ihre Qualität zu beurteilen, ist eine Herausforderung

Facilitators and barriers to health enhancing physical activity in individuals with severe functional limitations after stroke: A qualitative study

Background: Patients with chronic conditions are less physically active than the general population despite knowledge of positive effects on physical and mental health. There is a variety of reasons preventing people with disabilities from achieving levels of physical activities resulting in health benefits. However, less is known about potential facilitators and barriers for physical activity (PA) in people with severe movement impairments. The aim of this study was to identify obstacles and facilitators of PA in individuals with severe disabilities. Materials and methods: Using a qualitative approach to explore individuals’ subjective perspectives in depth, five community-dwelling adults (age 52–72, 2 female, 3 male) living with chronic mobility impairments after stroke that restrict independent PA were interviewed. A semi structured topic guide based on the theoretical domains framework was utilized. The interview data was analyzed thematically, and the theoretical domains framework constructs were mapped onto the main and sub-categories. Results: The six main categories of facilitators and barriers along the capability, opportunity, motivation–behavior (COM-B) framework were: (1) physical capabilities, (2) psychological capabilities, (3) motivation reflective, (4) motivation automatic, (5) opportunity physical, and (6) opportunity social. The physical capabilities to independently perform PA were variable between participants but were not necessarily perceived as a barrier. Participants were highly motivated to maintain and/or increase their abilities to master their everyday lives as independently as possible. It became clear that a lack of physical opportunities, such as having access to adequate training facilities can present a barrier. Social opportunities in the form of social support, social norms, or comparisons with others can act as both facilitators and barriers. Conclusion: While confirming known barriers and facilitators that impact the ability of individuals with functional limitations to be active, the findings highlight the need and opportunities for comprehensive service models based on interdisciplinary collaborations

Dose-response relationship of locomotor training in patients with spinal cord injury : preliminary results

Background: A large proportion of patients with spinal cord injury (SCI) regain ambulatory function. However, during the first 3 months most patients are unable to walk without support. To enable ambulatory training at such an early stage the body weight is partially relieved and leg movement assisted by two therapists. A more recent approach is the application of robotic-based assistance, which allows for longer training duration. From the science of motor learning and studies including patients with stroke, it is known that training effects depend on the duration of the training. Longer training results in a better walking function. Purpose: The aim of the present study is to evaluate whether prolonged robot-assisted walking training leads to a better walking outcome in patients with incomplete SCI, who are initially unable to walk independently (i.e. B and C according to the International Standards for Neurological Classification of SCI-ISNCSCI), and whether such training is feasible or is associated with undesirable effects. Methods: Patients from three sites with an acute incomplete SCI (within 60 days after injury) were randomized to either standard training (session duration 25 minutes) or intensive training (session duration 50 minutes). After 8 weeks of training walking ability (Walking Index for SCI-WISCI, scale 0-20: 0=not able to walk, 20= able to walk independently), the occurrence of adverse events and the rate of perceived exertion (RPE, scale 1-10: 1=very light, 10= very, very hard), as well as patients’ global impression of change (PGIC, scale 0 -10: 0= much better, 5= no change, 10= much worse) were compared between groups. Results: Seventeen patients with incomplete SCI were randomly assigned either to standard training (ISNCSCI B: n=6; C: n=2) or to intensive training (B: n=3; C: n=6). The average duration of training of the standard group was half the length of the intensive group (24.9±0.6 minutes vs. 48.3±3.2 minutes; p=0.01). Both groups performed an equal number of training sessions within 8 weeks (33.8±6.8 and 34.9±6.0; n.s.). The median WISCI changed from 0 to 4 in the standard group (n.s.) and from 0 to 10.5 (p<0.05) in the intensive group. However, the group difference after training did not reach statistical significance. The median RPE (standard: 6.5, range 1-10 and intensive: 6, range 1-10; n.s.) and the PGIC (standard: 3.5, range 0-5; intensive: 2.5, range 1-4; n.s.) did not differ between the standard and intensive training groups. Conclusions: Longer training using a robotic device is feasible and is not associated with undesirable effects in patients with incomplete SCI. Results show a trend towards a positive dose-response relationship. However, there was a larger proportion of patients with a motor incomplete SCI (i.e. ISNCSCI: C) in the intensive training group. Implications: The duration of a standard training session needs to be re-addressed. Results indicate that more intensive training leads to a better outcome

Feasibility and cost description of highly intensive rehabilitation involving new technologies in patients with post-acute stroke-a trial of the Swiss RehabTech Initiative

BACKGROUND There is a need to provide highly repetitive and intensive therapy programs for patients after stroke to improve sensorimotor impairment. The employment of technology-assisted training may facilitate access to individualized rehabilitation of high intensity. The purpose of this study was to evaluate the safety and acceptance of a high-intensity technology-assisted training for patients after stroke in the subacute or chronic phase and to establish its feasibility for a subsequent randomized controlled trial. METHODS A longitudinal, multi-center, single-group study was conducted in four rehabilitation clinics. Patients participated in a high-intensity 4-week technology-assisted trainings consisting of 3 to 5 training days per week and at least 5 training sessions per day with a duration of 45 min each. Feasibility was evaluated by examining recruitment, intervention-related outcomes (adherence, subjectively perceived effort and effectiveness, adverse events), patient-related outcomes, and efficiency gains. Secondary outcomes focused on all three domains of the International Classification of Functioning Disability and Health. Data were analyzed and presented in a descriptive manner. RESULTS In total, 14 patients after stroke were included. Participants exercised between 12 and 21 days and received between 28 and 82 (mean 46 ± 15) technology-assisted trainings during the study period, which corresponded to 2 to 7 daily interventions. Treatment was safe. No serious adverse events were reported. Minor adverse events were related to tiredness and exertion. From baseline to the end of the intervention, patients improved in several functional performance assessments of the upper and lower extremities. The efficiency gains of the trainings amounted to 10% to 58%, in particular for training of the whole body and for walking training in severely impaired patients. CONCLUSIONS Highly intensive technology-assisted training appears to be feasible for in- and outpatients in the subacute or chronic phase after stroke. Further clinical trials are warranted in order to define the most comprehensive approach to highly intensive technology-assisted training and to investigate its efficacy in patients with neurological disorders. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03641651 at August 31st 2018

Assessing usability of a prototype soft exoskeleton by involving people with gait impairments

Background: Gait impairment is prevalent among many growing clinical populations e.g. people with stroke, incomplete spinal cord injury (iSCI), older adults etc. Such populations may benefit from assistive devices such as exoskeletons to improve their walking ability. XoSoft (www.xosoft.eu) is a soft exoskeleton that is being developed for people with mild to moderate gait impairments to support their mobility by providing physical actuation across joints of the lower extremities. During the design and development of a device like XoSoft, it is crucial that Primary Users (PUs, e.g. patients) are involved and provide insight into their experiences and expectations regarding device usability. However, it is still not standard practice to include PUs in rigorous testing of highly technical exoskeletons. The XoSoft consortium took an iterative design approach to the development of the XoSoft prototypes. Data from usability testing with PUs are informing next iterations of the XoSoft concepts. Purpose: The purpose of this study was to assess the PU experiences of the usability of a XoSoft prototype. This study should also highlight the importance of including PUs during the development of assistive devices. Methods: Eleven participants were recruited (mean age: 73 years, mean height: 166 cm, mean mass: 65 kg). There were three categories of PUs: frail (n=5), stroke (n=1), iSCI (n=5). Participants had no cognitive impairment (Mini Mental State Examination score > 24). The prototype consisted of a leggings-style garment with Velcro straps as anchor points for actuators across the relevant joints (hip, knee, ankle). Actuation and control was provided by a modular pneumatic/sensor controlled system, which was added to the garment in modular fashion based on the PU needs. After independent donning and doffing by the participant, the garment was donned and the Velcro straps placed and secured by a researcher to ensure proper placement. Participants then performed walking tasks with active actuation followed by completion of the System Usability Scale (SUS, Brooke 1996, maximum score = 100). Results: The scores for the SUS ranged from zero to 95 with a median rating of 52.5. The median rating corresponds to an “okay” score. According to the acceptability ranges by Bangor et al. (2008), 3 participants rated the prototype as acceptable, 3 as marginal, and 5 as not acceptable. Conclusions: The scores indicate the need for improvement in the design of future XoSoft prototypes. The large variability in SUS scores indicated that the same device may be rated considerably differently by different users. This highlights the importance of including a variety of potential users of assistive devices during development. Implications: Secondary Users (SUs) such as physical therapists are also involved in the development of XoSoft, providing insight into their own needs and the needs of their patients. The therapists also play a key role in motivating their patients to participate in research and development projects. To ensure that such assistive devices can be integrated into users’ lives and practices, it is essential to have both PUs and SUs actively involved in the technical development

Effect of counselling during pulmonary rehabilitation on self-determined motivation towards physical activity in people with chronic obstructive pulmonary disease – protocol of a mixed methods study

Background: Physical activity promotion in people with Chronic Obstructive Pulmonary Disease (COPD) is focus of research and public health. Patient-centred interventions like counselling are promising approaches to help patients reducing sedentary behaviour. Aim of the present study is to investigate if a physical activity counselling program during pulmonary rehabilitation increases physical activity level in daily life in people with COPD. Methods: A two-armed, single blind randomised controlled trial including 56 people with COPD will be conducted in an outpatient pulmonary rehabilitation. Patients will participate in a 12-week-rehabilitation program; individuals randomized to the interventional group will additionally participate in five counselling sessions with a physiotherapist, based on the principles of motivational interviewing. The participants’ physical activity level will be measured using an accelerometer (SenseWear Pro®) before, directly and 3 months after pulmonary rehabilitation. Semi-structured interviews will be conducted to learn more about barriers and facilitators regarding daily physical activity. Discussion: If the strategy successfully improves the physical activity level in people with COPD, counselling might be implemented in pulmonary rehabilitation