Bringing rehabilitation home with an e-health platform to treat stroke patients: study protocol of a randomized clinical trial (RGS@home).
Por:
Mura A, Maier M, Ballester BR, De la Torre Costa J, Lopez J, Gelineau A, Mandigout S, Ghatan PH, Raffaele Fiorillo, Antenucci F, Coolen T, Chivite I, Callen A, Landais H, Gómez OI, Melero C, Brandi S, Domenech M, Daviet JC, Zucca R and Verschure PFMJ
Publicada:
20 jun 2022
Ahead of Print:
20 jun 2022
Resumen:
BACKGROUND: There is a pressing need for scalable healthcare solutions and a shift in the rehabilitation paradigm from hospitals to homes to tackle the increase in stroke incidence while reducing the practical and economic burden for patients, hospitals, and society. Digital health technologies can contribute to addressing this challenge; however, little is known about their effectiveness in at-home settings. In response, we have designed the RGS@home study to investigate the effectiveness, acceptance, and cost of a deep tech solution called the Rehabilitation Gaming System (RGS). RGS is a cloud-based system for delivering AI-enhanced rehabilitation using virtual reality, motion capture, and wearables that can be used in the hospital and at home. The core principles of the brain theory-based RGS intervention are to deliver rehabilitation exercises in the form of embodied, goal-oriented, and task-specific action. METHODS: The RGS@home study is a randomized longitudinal clinical trial designed to assess whether the combination of the RGS intervention with standard care is superior to standard care alone for the functional recovery of stroke patients at the hospital and at home. The study is conducted in collaboration with hospitals in Spain, Sweden, and France and includes inpatients and outpatients at subacute and chronic stages post-stroke. The intervention duration is 3 months with assessment at baseline and after 3, 6, and 12 months. The impact of RGS is evaluated in terms of quality of life measurements, usability, and acceptance using standardized clinical scales, together with health economic analysis. So far, one-third of the patients expected to participate in the study have been recruited (N = 90, mean age 60, days after stroke = 30 days). The trial will end in July 2023. DISCUSSION: We predict an improvement in the patients' recovery, high acceptance, and reduced costs due to a soft landing from the clinic to home rehabilitation. In addition, the data provided will allow us to assess whether the prescription of therapy at home can counteract deterioration and improve quality of life while also identifying new standards for online and remote assessment, diagnostics, and intervention across European hospitals. TRIAL REGISTRATION: C linicalTrials.gov NCT04620707. Registered on November 3, 2020.
Filiaciones:
Mura A:
Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), Barcelona, Spain
Maier M:
Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), Barcelona, Spain
Ballester BR:
Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), Barcelona, Spain
De la Torre Costa J:
Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), Barcelona, Spain
Lopez J:
Institut de Recerca Sant Joan de Déu, Barcelona, Spain
Parc Sanitari Sant Joan de Deu, Barcelona, Spain
Gelineau A:
HAVAE Laboratory EA 6310, University of Limoges, Limoges, France
Mandigout S:
HAVAE Laboratory EA 6310, University of Limoges, Limoges, France
Ghatan PH:
Uppsala University Hospital (UUH), Uppsala, Sweden
Raffaele Fiorillo:
Institut de Recerca Sant Joan de Déu, Barcelona, Spain
Parc Sanitari Sant Joan de Deu, Barcelona, Spain
Antenucci F:
Saddle Point Science Ltd., London, UK
Coolen T:
Fondation de l'Avenir pour la recherche médicale, Paris, France
Chivite I:
Institut de Recerca Sant Joan de Déu, Barcelona, Spain
Parc Sanitari Sant Joan de Deu, Barcelona, Spain
Callen A:
Institut de Recerca Sant Joan de Déu, Barcelona, Spain
Parc Sanitari Sant Joan de Deu, Barcelona, Spain
Landais H:
Eodyne Systems S.L., Barcelona, Spain
Gómez OI:
Medtronic Ibérica S.A., C/María de Portugal 11, Madrid, Spain
Melero C:
Medtronic Ibérica S.A., C/María de Portugal 11, Madrid, Spain
Brandi S:
Eodyne Systems S.L., Barcelona, Spain
Domenech M:
Eodyne Systems S.L., Barcelona, Spain
Daviet JC:
Department of Physical Medicine and Rehabilitation, University Hospital Center of Limoges, Limoges, France
Zucca R:
Hospital del Mar Medical Research Institute Foundation, IMIM, Barcelona, Spain
Verschure PFMJ:
Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), Barcelona, Spain.
Institució Catalana de Recerca i Estudis Avançats (ICREA), Barcelona, Spain.
|