MECO-FNR-Luxinnovation: Results of the first joint call for projects on health technologies

This project is proposing the development and validation of an early-stage development intervention, delivered by an expressive robot, QTrobot, as a novel digital therapeutic for at-home therapy of children with autism. The approach taken to validate the clinical effectiveness of the solution is a long-term, large scale and multinational clinical study which is one of its kind globally. The study compares the progress of children who receive the robot-based therapy at home, in addition to the usual care they are already receiving, in terms of social, cognitive, language and communication development as well as reduction of the autism symptomatology with progress of the children who only receive the usual care.

Autism spectrum disorder (ASD) is a childhood neurodevelopmental disorder affecting 1 in every 54 children and is presented with difficulties in social interaction and communication, restricted behaviours and interest and often delayed development in the areas of language, motor and cognitive among others.

Having no cure, life skills and autonomy of children with autism can be improved through early, intensive, and one-to-ne interventions, proven to be effective in reducing the needs for long term care and resulting in average cost saving of €1.1 million per person. However, due to the shortage of autism professionals and the high investments needed for delivering such interventions, children often do not receive sufficient interventions, if any.

QT can address the shortage of autism professionals by empowering parents to deliver standard and evidence-based therapies at home, providing effective, scalable, and affordable therapy for autistic children. In this project we are evaluating the effectiveness of this novel approach to early interventions for autism, delivered through a robot and in at-home setting. Furthermore, we are developing the necessary tools that can facilitate the delivery of the intervention with high level of fidelity, empowering parents of children with autism to create and optimise an individualized therapy plan for their children, to monitor their progress and contribute in their child’s development by playing an active role in the intervention, providing necessary prompts, reinforcements and interactions that are geared toward increasing the child’s ability to genialize the learnt skills from the robot to their natural social environment.

The project is a collaboration between the Luxembourg based company LuxAI, developer and manufacturer of QT and the Luxembourg Institute of Health, bringing together the specialties required for developing and clinically validating the QT as a medical device for at-home therapy of autistic children. The project also brings together autism scientists and clinicians from LU, DE, FR, IT and UK, proposing a novel and unique clinical study in terms of its scope, scale (190 participants in 5 countries) and duration (10-month intervention). By developing and validating a solution for an at-home robot-assisted therapy by parents, the project’s results are expected to provide considerable benefits in improving the health and well-being of autistic children and their families as well as to offer considerable reductions of autism costs for the public payers.

Asthma is one of the most common chronic diseases in children, and its prevalence has been rising globally during the past thirty years, touching up to 10% of the young population. Diagnosis and treatment are hampered by the fact that it is a heterogenous inflammatory disease with distinct underlying pathophysiological mechanisms. There is a medical need for non-invasive clinically applicable biomarkers to improve patient diagnosis and care. For children undergoing inhaled corticosteroid therapy, poor administration techniques and low compliance further influence therapy success.

In this project, we propose to combine biomarker research with a digital and easy to use technology monitoring administration of medication and quality of life of treated patients, aiming at an optimized and personalized medical care for children with chronic respiratory disease.

The medical unmet need – Patients with common orthopaedic conditions such as musculoskeletal injuries (e.g. bone trauma), arthrosis, and/or following surgical procedures (e.g., anterior cruciate ligament reconstructions, osteotomies or knee prosthesis) require long medical follow-up with regular medical visits and many rehabilitation sessions. These represent standardised examination in a controlled environment, and unfortunately, do not ensure the patient for a safe and normal return to daily activities without any complaints or functional impairment in the short, medium or long term. Indeed, patients may experience impairments, alterations of their gait pattern, changes in physical activity behaviour and inappropriate loading for their respective pathology during their daily life activities. This would put them at risk of suffering from long-term consequences (i.e., arthrosis, secondary injuries). The possibility to remotely monitor gait patterns in patients would help clinicians in many ways such as detecting gait metrics that are out of normal range, avoiding load in the injured/operated limb, or controlling progressive load on it. Thus, monitoring the patient’s progress in daily living conditions is essential for proper adjustment of their treatment as well as to avoid long-term consequences.

The digital health solution – The WalkinSense system consists of pressure-sensitive insoles combined with inertial measurement units and comprises both the hardware and digital environment for the analysis and management of patient’s data. This new digital health solution will provide healthcare professionals with important and relevant information on the progress of their patients in their natural environment by detailing aspects of both movement quality (e.g., step cadence, contact time, symmetry in lower limbs loading) and quantity (e.g., number of steps, stairs climbed per day).

The research project – The main purpose of this project is to develop and validate a new digital health solution (i.e., the WalkinSense system) for remote monitoring of gait patterns in patients with orthopaedic conditions during daily life activities. We will first collect feedback from healthcare professionals to help identify the most critical gait features needed to evaluate the status and progress of their patients. Then, we will assess the safety and performance of the new digital health solution in the laboratory. In a third step, we will test the device in the real world in patients with orthopaedic conditions. This feasibility study will provide valuable information on the possibility to recruit patients for future trials, the compliance of patients using such a digital health solution, comfort and ease-of-use of the system. In parallel to these studies, the WalkinSense software environment will be developed and permanently improved based on the feedback from the studies. The validation against gold standards will result in a set of improved gait metrics algorithms of WalkinSense. We will use surveys to collect feedback from both patients and healthcare professionals, which will help develop the digital environment to meet the end-user’s expectations.

Impact – The proposed project will enable us to make important steps toward bringing the new digital health solution to the market by validating the WalkinSense against the current gold standard for gait related applications, while following the regulatory path toward medical certification of the device.

The persistence of the COVID-19 disease symptoms, such as extreme fatigue, shortness of breath, cardiovascular complications, depression and anxiety, pain, brain fog, loss of taste/smell, headaches as well as loss of memory has been evoked in many studies. This project aims at approaching the persistent symptomatology on cognition, more than 1 year after the infection.

When we refer to cognition, we refer to everything associated with knowledge, that is, the accumulation of information we have acquired through learning or from our experience. We can define cognitive processes as the processes we use to incorporate new knowledge and make decisions based on it. Through these processes several cognitive functions intervene: perception, attention, memory, reasoning, language, learning, decision-making. All of these cognitive functions work together to integrate knowledge as a whole and create an interpretation of the world around us. Usually neuropsychological tests are used to evaluate cognitive problems, they consist in different exercises sometimes with words, figures to draw, images to remember, movement to repeat, numbers to link together etc.

The DigiCog project here propose

1) to test and validate a very novel device, which uses the eyes movement during tasks to evaluate very quickly the cognitive functioning;

2) to study potential cognitive problems long-term after COVID-19; and

3) to explore how cognition could be preserved.

Finally, this project will also help to bring the innovative device tested to the market, for accurately monitoring people with long COVID.