Finished
Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
NCT03951844 · Alessandra Pedrocchi · Updated 17 May 2019
- What is being tested
- BRIDGE/EMPATIA exoskeleton
- For
- Muscular Dystrophies
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages Not stated. About 14 people. The full rules are on the registry page.
- Where
- Italy (2 sites)
- When
- Starts or started 26 June 2018, ends 2 April 2019. Registered 15 May 2019.
- Results
- None posted yet.
In the researchers' words
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..
Sites
- IRCCS E. Medea - La Nostra FamigliaBosisio Parini, LC, Italy
- Villa BerettaCosta Masnaga, LC, Italy