NCT03951844

Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Alessandra Pedrocchi · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The study is a feasibility study or pilot study, that is a clinical investigation to acquire the preliminary information on a motorized exoskeleton (BRIDGE / EMPATIA exoskeleton) for the movement of the upper limb in order to develop it, including design changes. The primary objective of the clinical trial is to assess the fit, safety and usability of the device in supporting the execution of daily activities for patients suffering from muscular dystrophy. The risk analysis for the BRIDGE / EMPATIA device does not present particular criticalities that preclude the use of the device in the target population. In any case, during the trial eventual adverse events are recorded for the verification of safety..

Conditions

• Muscular Dystrophies

Interventions

Type	Name	Description
DEVICE	BRIDGE/EMPATIA exoskeleton	The participant wears the exoskeleton on his/her left arm, and he/she controls it by means of a joystick or vocal commands.

Timeline

• Start date: 2018-06-26
• Primary completion: 2019-04-02
• Completion: 2019-04-02
• First posted: 2019-05-15
• Last updated: 2019-05-17

Locations

2 sites across 1 country: Italy