NCT03127241

User-centred Assistive System for Arm Functions in Neuromuscular Subjects

USEFUL: User-centred Assistive SystEm for Arm Functions in neUromuscuLar Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Politecnico di Milano · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Muscular Dystrophy, Becker
• Muscular Dystrophy, Limb-Girdle Type 2

Interventions

Type	Name	Description
DEVICE	Assistive device (Armon Ayura) test	Short Training (T0-T1) - each subject will undergo a 3-day training at the clinical center during which technicians, along with a physiotherapist will adjust and customize the device and explain possible independent use at home. Domestic use (T1-T2) - Subjects will use the device during their daily life activities for two weeks at home. They will perform task-oriented movements (e.g. reaching a mouse and objects on a table, moving back to the wheelchair, drinking), free movements, playful activities (e.g. playing chess, leafing through a book), and self-care activities, accordingly to subject's residual capability, for a minimum period of 5 hours/day. They will keep a structured diary where all the problems, achievements and comments will be reported.
DEVICE	Assistive device (Jaeco Wrex) test	Short Training (T0-T1) - each subject will undergo a 3-day training at the clinical center during which technicians, along with a physiotherapist will adjust and customize the device and explain possible independent use at home. Domestic use (T1-T2) - Subjects will use the device during their daily life activities for two weeks at home. They will perform task-oriented movements (e.g. reaching a mouse and objects on a table, moving back to the wheelchair, drinking), free movements, playful activities (e.g. playing chess, leafing through a book), and self-care activities, accordingly to subject's residual capability, for a minimum period of 5 hours/day. They will keep a structured diary where all the problems, achievements and comments will be reported.

Timeline

• Start date: 2017-06-16
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2017-04-25
• Last updated: 2019-12-10

Locations

2 sites across 1 country: Italy