Roessingh Research and Development

Purpose Amyotrophic Lateral Sclerosis (ALS) is a progressive disease leading to loss of muscle strength and control, and as such limiting patients’ independence. Assistive devices can help individuals with ALS; however, their use by ALS patients is limited. To increase use rates, we expect that devices need to be tailored to ALS patients. The aim of this study was to identify wishes, requirements and values of ALS patients regarding assistive devices for the upper extremity through focus groups involving ALS patients, their relatives and medical professionals. Methods and Materials Four focus groups were conducted, recorded and transcribed. Two focus groups with ALS patients and their relatives contained a “Day in a Life” and “Empathy map” method, while during two focus groups with medical professionals, “Day in the Life” method and “Provoking statements” were used. Activities mentioned were counted and categorized into “Daily activities” and “Elective activities”. Results Qualitative analysis of transcripts yielded three themes: (1) ALS patients’ considerations on use and wishes for assistive devices, (2) external factors influencing the use of assistive devices and (3) change in ALS patients’ needs over time. In addition to maintaining independence in activities of daily living, the results highlight that retaining the ability to perform elective activities such as hobbies, is important. Moreover, there is a clear need for assistive devices designed for ALS patients with limited upper extremity strength, but who are not confined to a wheelchair. Conclusion These findings can guide the development of assistive devices tailored to the needs of ALS patients.

Objective: To map nutritional care provided to people with ALS, PMA and PLS (pwALS) and identify barriers encountered by healthcare professionals and pwALS. Methods: Two online questionnaires, addressing current nutritional management of ALS in the Netherlands, were sent to healthcare professionals of the 36 certified ALS care teams and pwALS drawn from a population-based registry. Topics were: 1) contact between pwALS and their ALS care team, 2) monitoring nutritional status, 3) nutritional advice provided or received, and 4) satisfaction with current nutritional care and barriers encountered. Results: In total, 100 healthcare professionals and 372 pwALS completed the questionnaires. Dietitian responses (n = 36/100) showed that 28% utilized malnutrition screening tools and 17% measured body composition. Dietitians used different predictive equations to estimate energy and protein requirements. Patient responses showed that 50% had contact with a dietitian, 7% indicated body composition had been measured and 25% reported never being weighed or weighing themselves. Healthcare professionals and pwALS highlighted the need for comprehensive, up-to-date information on nutrition and ALS, national consensus on nutritional advice and monitoring methods, patient information material, training for healthcare professionals and personalized nutritional advice for pwALS. Conclusions: Practice variation was observed in the assessment and monitoring of nutritional status and the provision of nutritional advice. Suboptimal monitoring of nutritional status and estimation of nutritional requirements may result in delayed detection of malnutrition and inaccurate dietary recommendations. Further research and national consensus on monitoring methods and nutritional advice is required.

Neurological disorders, such as stroke, can affect the ability to walk and balance. Robotic rehabilitation assists in training walking and balance capabilities of patients with neurological disorders. However, not all participants are good responders when using exoskeletons. This study aims to cluster gait patterns in stroke patients to provide insights into the pathology of stroke patients. Joint angles of the affected lower limb of 45 sub-acute stroke patients from an open access database were clustered based on a principal component analyses, followed by a k-means cluster analysis. A total of eight gait pattern clusters were retrieved and clinically rearranged into four categories. The results can be used in the field of robotic devices as well as a more clinical setting. Future research should focus on validating and using the retrieved clusters as clinical indicators for selecting suitable treatments, such as robotic devices or exoskeletons, to personalize rehabilitation.

BackgroundVirtual reality (VR) could possibly alleviate complaints related to chronic musculoskeletal pain (CMP); however, little is known about how it affects pain-related variables on an individual level and how patients experience this intervention.ObjectiveThis study aimed to gain detailed insight into the influence of an at-home VR intervention for pain education and management on pain-related variables, and to explore its feasibility and general experience.MethodsThe study applied a single-case experimental design in which an at-home VR intervention was used for 4 weeks by patients with CMP who were on a waiting list for regular pain treatment. Outcome measures included pain-related variables, functioning, and objectively measured outcomes (ie, stress, sleep, and steps). Outcomes were analyzed using data visualization (based on line plots) and statistical methods (ie, Tau-U and reliable change index) on an individual and group level. In addition, a focus group was conducted to assess feasibility and general experience to substantiate findings from the single-case experimental design study. This focus group was analyzed using inductive thematic analysis.ResultsA total of 7 participants (female: n=6, 86%) with a median age of 45 (range 31‐61) years participated in this study. A dataset with 42 measurement moments was collected with a median of 280 (range 241‐315) data points per participant. No statistically significant or clinically relevant differences between the intervention and no-intervention phases were found. Results of the visual analysis of the diary data showed that patients responded differently to the intervention. Results of the focus group with 3 participants showed that the VR intervention was perceived as a feasible and valued additional intervention.ConclusionsAlthough patients expressed a positive perspective on this VR intervention, it did not seem to influence pain-related outcomes. Individual patients responded differently to the intervention, which implies that this intervention might not be suitable for all patients. Future studies should examine which CMP patients VR is effective for and explore its working mechanisms. In addition, future larger trials should be conducted to complement this study’s findings on the effectiveness of this intervention for patients with CMP and whether VR prevents deterioration on the waiting list compared with a control group.

BackgroundArtificial intelligence (AI) tools hold much promise for mental health care by increasing the scalability and accessibility of care. However, current development and evaluation practices of AI tools limit their meaningfulness for health care contexts and therefore also the practical usefulness of such tools for professionals and clients alike.ObjectiveThe aim of this study is to demonstrate the evaluation of an AI monitoring tool that detects the need for more intensive care in a web-based grief intervention for older mourners who have lost their spouse, with the goal of moving toward meaningful evaluation of AI tools in e-mental health.MethodWe leveraged the insights from three evaluation approaches: (1) the F1-score evaluated the tool’s capacity to classify user monitoring parameters as either in need of more intensive support or recommendable to continue using the web-based grief intervention as is; (2) we used linear regression to assess the predictive value of users’ monitoring parameters for clinical changes in grief, depression, and loneliness over the course of a 10-week intervention; and (3) we collected qualitative experience data from e-coaches (N=4) who incorporated the monitoring in their weekly email guidance during the 10-week intervention.ResultsBased on n=174 binary recommendation decisions, the F1-score of the monitoring tool was 0.91. Due to minimal change in depression and loneliness scores after the 10-week intervention, only 1 linear regression was conducted. The difference score in grief before and after the intervention was included as a dependent variable. Participants’ (N=21) mean score on the self-report monitoring and the estimated slope of individually fitted growth curves and its standard error (ie, participants’ response pattern to the monitoring questions) were used as predictors. Only the mean monitoring score exhibited predictive value for the observed change in grief (R2=1.19, SE 0.33; t16=3.58, P=.002). The e-coaches appreciated the monitoring tool as an opportunity to confirm their initial impression about intervention participants, personalize their email guidance, and detect when participants’ mental health deteriorated during the intervention.ConclusionsThe monitoring tool evaluated in this paper identified a need for more intensive support reasonably well in a nonclinical sample of older mourners, had some predictive value for the change in grief symptoms during a 10-week intervention, and was appreciated as an additional source of mental health information by e-coaches who supported mourners during the intervention. Each evaluation approach in this paper came with its own set of limitations, including (1) skewed class distributions in prediction tasks based on real-life health data and (2) choosing meaningful statistical analyses based on clinical trial designs that are not targeted at evaluating AI tools. However, combining multiple evaluation methods facilitates drawing meaningful conclusions about the clinical value of AI monitoring tools for their intended mental health context.

Stakeholder involvement is crucial to ensure health technologies meet stakeholders’ needs and values. A method to elicit these values is the patient journey value map (PJVM). A disadvantage of this method is its high burden for participants. In this paper, we adapted the PJVM method to minimise the burden and evaluated whether with this adaptation, values of stroke survivors can be elicited. We conducted interviews (N=6) and an interactive session with seven stroke survivors. Our approach showed that this adaptation in PJVM still allows to elicit end-users’ values throughout the patient journey, but in a less time-consuming manner and with less effort for participants. The method enabled stroke survivors to identify and articulate their values. This study contributes by showing that the adapted PJVM method is a useful and flexible method when investigating values in healthcare in the real world.

Background:Although early rehabilitation is important following a stroke, severely affected patients have limited options for intensive rehabilitation as they are often bedridden. To create a system for early rehabilitation of lower extremities in these patients, we combined the robotic manipulator ROBERT® with electromyography (EMG)-triggered functional electrical stimulation (FES) and developed a novel user-driven Assist-As-Needed (AAN) control. The method is based on a state machine able to detect user movement capability, assessed by the presence of an EMG-trigger and the movement velocity, and provide different levels of assistance as required by the patient (no support, FES only, and simultaneous FES and mechanical assistance). Methods:To technically validate the system, we tested 10 able-bodied participants who were instructed to perform specific behaviors to test the system states while conducting knee extension and ankle dorsal flexion exercises. The system was also tested on two stroke patients to establish its clinical feasibility. Results:The technical validation showed that the state machine correctly detected the participants’ behavior and activated the target AAN state in more than 96% of the exercise repetitions. The clinical feasibility test showed that the system successfully recognized the patients’ movement capacity and activated assistive states according to their needs providing the minimal level of support required to exercise successfully. Conclusions:The system was technically validated and preliminarily proved clinically feasible. The present study shows that the novel system can be used to deliver exercises with a high number of repetitions while engaging the participants’ residual capabilities through the AAN strategy.

After an ACL injury, rehabilitation consists of multiple phases, and progress between these phases is guided by subjective visual assessments of activities such as running, hopping, jump landing, etc. Estimation of objective kinetic measures like knee joint moments and GRF during assessment can help physiotherapists gain insights on knee loading and tailor rehabilitation protocols. Conventional methods deployed to estimate kinetics require complex, expensive systems and are limited to laboratory settings. Alternatively, multiple algorithms have been proposed in the literature to estimate kinetics from kinematics measured using only IMUs. However, the knowledge about their accuracy and generalizability for patient populations is still limited. Therefore, this article aims to identify the available algorithms for the estimation of kinetic parameters using kinematics measured only from IMUs and to evaluate their applicability in ACL rehabilitation through a comprehensive systematic review. The papers identified through the search were categorized based on the modelling techniques and kinetic parameters of interest, and subsequently compared based on the accuracies achieved and applicability for ACL patients during rehabilitation. IMUs have exhibited potential in estimating kinetic parameters with good accuracy, particularly for sagittal movements in healthy cohorts. However, several shortcomings were identified and future directions for improvement have been proposed, including extension of proposed algorithms to accommodate multiplanar movements and validation of the proposed techniques in diverse patient populations and in particular the ACL population.

Abstract Study design: multiphase single arm intervention study Objectives: The primary goal is to establish the safety of cervical infusion of intrathecal baclofen (ITB) on pulmonary and respiratory functions and sleep related disorders in persons with spinal cord injury (SCI). The secondary goal is to explore the effect of cervical ITB on reduction of spasticity and improvement at the level of functions and activities. Settings: General hospital and rehabilitation centre, The Netherlands Methods: The first phase involves a safety study in persons with SCI with functionally hindering spasticity of the upper extremity. In this phase an extracorporeal pump will be used to investigate whether cervical ITB leads to reduction of spasticity without an adverse effect on respiratory function and sleep related disorders. In case of a safe (no adverse effects) and positive (reduction of spasticity) result of the test, a baclofen pump will be implanted in the second phase of the study. The dosage of ITB will be slowly increased and oral spasmolytics phased out. At 3, 6, and 12 months after discharge, a pulse-oximetry will be performed and pulmonary function, respiratory function, level of spasticity and the level of function and activities will be assessed. Conclusion: Little is known, at present, about safety and effectiveness of cervical ITB for the treatment of upper extremity spasticity. We aim to establish the safety and efficacy of this procedure. This paper describes the protocol of this safety study.