Periodic Reporting for period 1 - iReach (New multisensory technology for early intervention in infants with visual impairment)
Reporting period: 2023-01-01 to 2024-06-30
Vision is crucial for developing skills to interact with space, objects, and people. Visual impairments significantly affect infants, hindering motor skills, spatial perception, and social interactions, with profound consequences for physical health, psychological well-being, and healthcare needs. Vision is essential for integrating sensory inputs, motion, and body perception, especially during the early years when cortical plasticity is at its peak. Early therapeutic interventions are vital for improving the quality of life for visually impaired infants. There is a clear need for easy, non-invasive technology for these infants. Advances in understanding the role of visual input in multisensory spatial development support this initiative. However, creating multisensory devices for the spatial rehabilitation of visually impaired infants has been challenging.
The goal was to design, develop, and validate the iReach technology, a wearable device that provides intuitive and accurate stimulation of spatial and body representations for visually impaired infants. It uses multisensory-motor signals to offer audio and tactile information about arm position. This technology aims to restore a unified sensory-motor-body representation, addressing the multisensory spatial processing challenges faced by blind infants.
The goal was to design, develop, and validate the iReach technology, a wearable device that provides intuitive and accurate stimulation of spatial and body representations for visually impaired infants. It uses multisensory-motor signals to offer audio and tactile information about arm position. This technology aims to restore a unified sensory-motor-body representation, addressing the multisensory spatial processing challenges faced by blind infants.
The iReach project has led to the development of a first prototype, iHelpY, a multisensory device designed to improve motor exploration and reaching skills in visually impaired infants. This device enables therapists to control various types of stimulation—such as auditory, tactile, and multisensory—while the infant performs hand movements, such as reaching for a ball on a table (Gori et al., 2024). The first validation study highlighted that iHelpY significantly improves how a blind child plans and prepares their hand to grasp for an object thus highlighting that multisensory stimulation can enhance motor performance in visually impaired infants. The results of this pilot study allowed us to put the basis for the development of the iReach device and the clinical protocol to validate the technology. iReach, is a non-CE-marked multisensory device consisting of two components called Anchors and a Reference Tag, all of which can be positioned on the body or on external objects. Each Anchor measures its distance from the Tag and translates this measurement into sensory feedback, with adjustable parameters for intensity and duration. iReach can emit auditory, vibrational, and RGB light stimuli, either individually or in combination. The device is powered on via a button located on its outer shell, does not feature a high-level software and it is both non-invasive and painless.
The device was developed and tested in the laboratory prior to clinical validation. We aim indeed to scientifically and clinically validate whether intensive use of iReach over a one-month rehabilitative training can enhance spatial and sensorimotor skills and facilitate cortical reorganization in visually impaired children aged 3 to 36 months. During the rehabilitation, children will participate in age-appropriate motor tasks performed both at the clinic and at home with the the iReach device. We have planned to run a follow-up experimental session to assess whether the improvements from the training are maintained after four months. Five centers will be involved in the validation: the IRCCS "La Nostra Famiglia" in Bosisio Parini (LC), which is the coordinating center; the IRCCS "Fondazione Casimiro Mondino" in Pavia (PV); the IRCCS "Stella Maris" in Calambrone (PI); the IRCCS "Giannina Gaslini" in Genoa (GE); and the Fondazione "David Chiossone" in Genoa (GE). The study has been already approved by the Ethics Committee of the coordinating center.
The device was developed and tested in the laboratory prior to clinical validation. We aim indeed to scientifically and clinically validate whether intensive use of iReach over a one-month rehabilitative training can enhance spatial and sensorimotor skills and facilitate cortical reorganization in visually impaired children aged 3 to 36 months. During the rehabilitation, children will participate in age-appropriate motor tasks performed both at the clinic and at home with the the iReach device. We have planned to run a follow-up experimental session to assess whether the improvements from the training are maintained after four months. Five centers will be involved in the validation: the IRCCS "La Nostra Famiglia" in Bosisio Parini (LC), which is the coordinating center; the IRCCS "Fondazione Casimiro Mondino" in Pavia (PV); the IRCCS "Stella Maris" in Calambrone (PI); the IRCCS "Giannina Gaslini" in Genoa (GE); and the Fondazione "David Chiossone" in Genoa (GE). The study has been already approved by the Ethics Committee of the coordinating center.
Thanks to the approval of the Ethical Committee, we are able now to start the study. Meanwhile, we are proceeding with the necessary procedures to obtain certification for iReach as a medical device from the Italian Ministry of Health, even though it is not specifically the main goal of the POC. The clinical validation of the technology will be carried out in the last year of the ERC Starting Grant "MySpace" from which the POC originates.
To bring the results of the POC to market, we have laid the groundwork for the establishment of a social impact startup: SoBu (Sound and Buzz). SoBu is an app compatible with smartphones and smartwatches that offers a range of interactive games. By combining sounds and vibrations with body movements, these games promote motor skills and social interaction, helping visually impaired children engage with their environment and others. SoBu includes group games like "Red Light Green Light" and “Hide and Seek,” making them accessible to the visually impaired kid for the first time. Additionally, it features daily life activities presented as games, such as reaching a person or grasping an object. Some of these games originate from the iReach functionalities.
In terms of competition, current market offerings are primarily DIY tactile games that users build themselves or tactile games used in clinical settings. Additionally, there are apps and video games that do not promote physical movement. Our goal is to encourage social interaction through movement, aiding the development of visually impaired children and addressing a significant gap in existing market solutions.
The business model for SoBu is freemium. Users can try the app for free for 30 days and then choose between a monthly or annual subscription. Alternatively, they can continue using the app for free with a limited set of features. Our initial target market will be families and legal guardians of visually impaired children. In the future, we aim to enter the clinical sector so that SoBu can also be used in rehabilitation and serve as a tool for doctors and therapists to monitor the child's progress over time. The estimated market size includes a Total Addressable Market (TAM) of approximately 1 billion euros, representing families worldwide; a Serviceable Obtainable Market (SOM) of about 61 million euros, representing families from high-income countries; and a Serviceable Available Market (SAM) of around 4 million euros, representing Italian families. Regarding IP protection, as SoBu is an app, the software is protected by trade secret/copyright, and the know-how is owned by the Italian Institute of Technology.
The startup team will include members from the iReach project: Walter Setti as CEO (Biomedical Engineer, PhD), Davide Esposito as COO (Biomedical Engineer, PhD), and Nicolò Balzarotti as CTO (Psychologist, PhD). The team also includes Emanuele Musini as Growth Advisor and Monica Gori as Scientific Advisor.
To bring the results of the POC to market, we have laid the groundwork for the establishment of a social impact startup: SoBu (Sound and Buzz). SoBu is an app compatible with smartphones and smartwatches that offers a range of interactive games. By combining sounds and vibrations with body movements, these games promote motor skills and social interaction, helping visually impaired children engage with their environment and others. SoBu includes group games like "Red Light Green Light" and “Hide and Seek,” making them accessible to the visually impaired kid for the first time. Additionally, it features daily life activities presented as games, such as reaching a person or grasping an object. Some of these games originate from the iReach functionalities.
In terms of competition, current market offerings are primarily DIY tactile games that users build themselves or tactile games used in clinical settings. Additionally, there are apps and video games that do not promote physical movement. Our goal is to encourage social interaction through movement, aiding the development of visually impaired children and addressing a significant gap in existing market solutions.
The business model for SoBu is freemium. Users can try the app for free for 30 days and then choose between a monthly or annual subscription. Alternatively, they can continue using the app for free with a limited set of features. Our initial target market will be families and legal guardians of visually impaired children. In the future, we aim to enter the clinical sector so that SoBu can also be used in rehabilitation and serve as a tool for doctors and therapists to monitor the child's progress over time. The estimated market size includes a Total Addressable Market (TAM) of approximately 1 billion euros, representing families worldwide; a Serviceable Obtainable Market (SOM) of about 61 million euros, representing families from high-income countries; and a Serviceable Available Market (SAM) of around 4 million euros, representing Italian families. Regarding IP protection, as SoBu is an app, the software is protected by trade secret/copyright, and the know-how is owned by the Italian Institute of Technology.
The startup team will include members from the iReach project: Walter Setti as CEO (Biomedical Engineer, PhD), Davide Esposito as COO (Biomedical Engineer, PhD), and Nicolò Balzarotti as CTO (Psychologist, PhD). The team also includes Emanuele Musini as Growth Advisor and Monica Gori as Scientific Advisor.