Testing with the users
Users will be recruited among ALS patients assisted in the ALSC, where they receive comprehensive medical care and psychological support. Clinical assessment, coordinated by a specialist neurologist, is focused on neuromuscular impairment (MRC scale for muscle strength, ALS functional rating scale, electrophysiological evaluation), bulbar affection (e.n.t. and logopedist examination, laryngoscopy), respiratory function and nutrition. Psychological support as provided by CDL, is patient tailored according to a psychological evaluation (based on standardized scales) and a familial-social context assessment. Patients will be recruited according to presence of speech disturbances leading to various degree of communication difficulties (depending both on the extent of bulbar affection and the involvement of other districts such as upper limbs to write or operate communicators), provided that at least another communication channel is preserved.
In the design period of the prototype, approximately 50 users will be involved for specific requirement survey; an ad-hoc interview will be designed by psychologist and clinicians together with the technical partners in order to explore specific needs that will be subsequently developed in the prototype implementation. Areas of interest will be: use of mainstream communication aids, control of electrical devices at home, basic communication skills in a portable form (to be used outside their home and with people other than their caregivers).
The 1st round experimentation (FSL) will include about 10 selected users to test the first prototype in a designed environment which is totally under domotic control, allowing a thorough assessment of system functionalities; showcase location nearby the laboratory will allow full technical support. Inclusion/exclusion criteria will be based on: degree of motor impairment (mobility), motivation, familial support. Main aim is to assess comfort of use of system’s functionalities. In the 2nd round experimentation about 10 users will be selected to test the final prototype at their home: this would bring relief of effort for the user and caregiver (allowing inclusion of people with greater mobility difficulties) and longer experimental session. Main aims are: assessment of improvement of user’s QoL; testing issues with the system in an unstructured environment. Caregiver training to configure the system and user training to operate the system will be performed.
Before and after prototype testing both users and caregivers will be assessed in terms of Quality of lLife, specific evaluation metrics will be identified or purposely developed in order to assess user satisfaction with regard to improvement of communication abilities, immediacy, easiness to use and acceptability of the device. A formal validation of the system is planned, based on standard scales designed for assistive devices (e.g., PIADS).