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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2019-04-02

Brief Summary

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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..

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Detailed Description

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Conditions

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Muscular Dystrophies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

BRIDGE/EMPATIA exoskeleton

Intervention Type DEVICE

The participant wears the exoskeleton on his/her left arm, and he/she controls it by means of a joystick or vocal commands.

Interventions

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BRIDGE/EMPATIA exoskeleton

The participant wears the exoskeleton on his/her left arm, and he/she controls it by means of a joystick or vocal commands.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes