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

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

Sponsors

Lead sponsor: Alessandra Pedrocchi

Source Politecnico di Milano
Brief Summary

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..

Overall Status Completed
Start Date June 26, 2018
Completion Date April 2, 2019
Primary Completion Date April 2, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Performance of Upper Limbs scale (PUL) Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
Secondary Outcome
Measure Time Frame
ABILHAND Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
Technology acceptance model (TAM) questionnaire Within 15 days from the baseline
System usability scale (SUS) Within 15 days from the baseline
Enrollment 14
Condition
Intervention

Intervention type: Device

Intervention name: BRIDGE/EMPATIA exoskeleton

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

Arm group label: Experimental group

Eligibility

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Location
facility
IRCCS E. Medea - La Nostra Famiglia | Bosisio Parini, LC, 23842, Italy
Villa Beretta | Costa Masnaga, LC, 23845, Italy
Location Countries

Italy

Verification Date

May 2019

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Politecnico di Milano

Investigator full name: Alessandra Pedrocchi

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Experimental group

Arm group type: Experimental

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

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov