Activity 1
Define protocols for pre-pilot testing of zero generation in Belgium and the Netherland.
Protocols for pre-pilot actions will be designed for hospital testing in an environment that serves as a transition between hospital care and home-based treatment (home-simulated environment). This approach allows for a realistic assessment of the rehabilitation system's performance and usability. All clinical partners and technical partners of all countries will be involved, with SMK and KU Leuvenhosp taking the lead. Medical ethical approval for the pre-pilots will be obtained, ensuring compliance with medical and ethical guidelines. This requires a backtracking loop with the developer teams.
Activity 2
Pre-Pilots of v0 in the Netherlands and Belgium in the Hospital setting
To assess the usability and feasibility of the system, pre-pilot tests will be conducted in the Netherlands (SMK) and Belgium (KU Leuven-hosp) with two groups: healthy adults and patients with neurological disorders aged 16 years and older. These age restrictions are in line with the requirements of the Medical Device Regulation and the medical ethical committee. Although the participants will be older than the target population of younger children, their body metrics will match those of the intended users.
Activity 3
Define protocols for pilot testing of first generation (V1) in NWE.
Based on the results of activity 2, protocols for pilots will be designed for hospital testing the modules developed in an environment that serves as a transition between hospital care and home-based treatment. The target participants for these pilots will be children below 16 years old with neurological disorders. The protocols will involve the collaboration of all clinical and technical partners across the countries involved (NL, BE, FR, GER).
Activity 4
Pilot of first generation in children with neurological disorders in NWE.
Pilots will be performed in children below 16 years old with neurological disorders in various regions of NWE regions (NL, BEL, FR, GER). The primary focus of the pilot tests will be to assess the feasibility and acceptability of the first generation (V1) developed.
The pilots will consist of a series of training sessions, typically ranging between 4-8 sessions for the exoskeleton modules and multiple sessions per week for the home rehabilitation program. The pilots will be used to evaluate the short-term effects of the interventions on the children's rehabilitation progress.
Activity 5
Define protocols for pilots of second versions in NWE.
Building upon the findings of activity 4, protocols will be developed for the pilot testing of the second version (V2) of the modules in children below 16 years old with neurological disorders in four regions of NWE.
Regular sessions will be held to discuss and refine the design of the protocols, allowing for input and collaboration from all stakeholders. These sessions will provide an opportunity for the clinical and technical partners to align their efforts and ensure the protocols are comprehensive, effective, and suitable for the transition from hospital care to home-based treatment.
Activity 6
Pilots of second versions in children with neurological disoders in NWE.
Pilots will feature the improved versions of the exoskeleton modules, smart garment and ITplatform developed as part of the second-generation technology development. These pilots will involve children with neurological disorders below the age of 16 in NWE regions (NL, BE, FR, GER). To ensure ecological validity, the pilots will be conducted in environments that reflect real-world scenarios: exoskeleton modules will be tested in a hospital setting, while the smart garment and IT-platform will be evaluated in a home setting.
The pilots will consist of an optimal number of training sessions, based on the findings from the activity 4, to assess the short-term effects of the interventions on the rehabilitation progress of the children.