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

Alessandra Pedrocchi

Status: Completed

Conditions: Muscular Dystrophies

Treatments: Device: BRIDGE/EMPATIA exoskeleton

Study type: Interventional

Funder types: Other

Identifiers

NCT03951844

GIP-530

Details and patient eligibility

About

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..

Enrollment: 14 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Availability of the patient and/or caregiver at the signing of the informed consent for participation in a clinical trial study protocol
2. Defined diagnosis of Muscular Dystrophy (Duchenne, Becker, Cingoli type 2 and facio-scapulo-humeral). Biopsy will not be performed except in cases where a diagnostic need arises.
3. Wheelchair bounded
4. Significant weakness in the muscular districts of the shoulder girdle and the proximal upper limb portion detected by the MRC scale (between 0 and 2)
5. Cognitive skills that allow the understanding and management of the device
6. Arm length measured from the shoulder to the elbow between 26.5 cm and 28.7 cm; forearm length, measured between elbow and wrist, maximum 22.4 cm

Exclusion criteria

1. Presence of important comorbidities (epilepsy, dependence 24/24 hours from non-invasive and invasive ventilation)
2. Behavioral and psychiatric disorders (e.g., emotional problems, depression)
3. Inability to maintain a sitting position in a wheelchair

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Experimental group

Experimental group

Description:

Each participant is evaluated while wearing or not wearing the device.

Treatment:

Device: BRIDGE/EMPATIA exoskeleton