AllyArm approached the TEF-Health ecosystem seeking support in the validation pathway of ALLY-06, an innovative upper-limb exoskeleton designed to assist people with severe neuromotor impairments in performing Activities of Daily Living (ADLs).
Mounted directly on the user’s wheelchair, ALLY-06 supports actions such as reaching objects, touching the face, or drinking. The device combines a modular design with multiple control interfaces, including joystick, app-based interaction, and vocal commands, allowing the system to adapt to the user’s residual abilities and needs.
A key achievement of the collaboration was the demonstration of the clinical equivalence between ALLY-06 and the previously developed BRIDGE exoskeleton. The equivalence assessment confirmed comparable technical, kinematic, and clinical characteristics between the two systems, enabling the transfer of existing clinical evidence to ALLY-06 in compliance with MDR 2017/745 requirements.
The clinical evidence used as reference for the equivalence assessment was derived from the BRIDGE clinical investigation (approved by the Italian Ministry of Health and the relevant Ethics Committees, publicly available on ClinicalTrials.gov under identifier NCT03951844) and from the publication:
Gandolla M. et al., “An assistive upper-limb exoskeleton controlled by multi-modal interfaces for severely impaired patients: development and experimental assessment”, Robotics and Autonomous Systems, Vol. 143, 2021, Article 103822. DOI: https://doi.org/10.1016/j.robot.2021.103822
The device has eventually been certified as class I.