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completed

User-centred Assistive System for Arm Functions in Neuromuscular Subjects

key information

study id #: NCT03127241

condition: Muscular Dystrophies, Duchenne Muscular Dystrophy, Limb-Girdle Type 2 Muscular Dystrophy, Becker Muscular Dystrophy

status: completed

purpose:

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.

intervention: Assistive device (Armon Ayura) test, Assistive device (Jaeco Wrex) test

mechanism of action: No pharmaceutical intervention

results: https://clinicaltrials.gov/ct2/show/results/NCT03127241

last updated: December 24, 2019

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