Muscular Dystrophies Clinical Trial
Official title:
USEFUL: User-centred Assistive SystEm for Arm Functions in neUromuscuLar Subjects
Restore a lost function is a special experience for people affected by neuromuscular
evolutive diseases. "From the patient's point of view improvement is measured by regaining
lost abilities,-by being able to do something -anything-today I couldn't do yesterday ".
Upper limb pain, stiffness and activity limitations have a crucial role in reducing patients'
autonomy and worsening quality of life.
Real users' needs have been identified thought several workshops, and even if the commercial
products might assure a benefit to some users and meet most of their requirements, so far a
validation of the use of such devices by people with neuromuscular disease is missing.
We aim at field-testing the improvement in arm functions provided by the use of some
commercial devices and assessing their impact to users' quality of life and independence.
This step is essential to assure a widespread accessibility to these devices for most of the
potential users, possibly providing health providers with direction and guidance towards
Health Technology Assessment.
Clinical Trial design - The study proposes on-field validation of JAECO WREX, passive
antigravity exoskeleton; and Armon Ayura, motorized arm exoskeleton for gravity compensation
in a randomized controlled trial with crossover design. The clinical study will is
multi-centric, involving both MEDEA and VALDUCE, and received the Ethical Committee approval.
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