Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Performance of Upper Limbs scale (PUL)
Study Overview
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..
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Availability of the patient and/or caregiver at the signing of the informed consent for participation in a clinical trial study protocol
- •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.
- •Wheelchair bounded
- •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)
- •Cognitive skills that allow the understanding and management of the device
- •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
- •Presence of important comorbidities (epilepsy, dependence 24/24 hours from non-invasive and invasive ventilation)
- •Behavioral and psychiatric disorders (e.g., emotional problems, depression)
- •Inability to maintain a sitting position in a wheelchair
Arms & Interventions
Experimental group
Each participant is evaluated while wearing or not wearing the device.
Intervention: BRIDGE/EMPATIA exoskeleton (Device)
Outcomes
Primary Outcomes
Performance of Upper Limbs scale (PUL)
Time Frame: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
The PUL includes 22 items with an entry item to define the starting functional level and 21 items subdivided into shoulder level (4 items), middle level (9 items) and distal level (8 items). For weaker patients, a low score on the entry item means high-level items do not need to be performed. Each dimension can be scored separately with a maximum score of 16 for the shoulder level, 34 for the middle level and 24 for the distal level. A total score can be achieved by adding the three level scores, with a maximum global score of 74. The lower the score, the higher the disability. Pane et al., Reliability of the Performance of Upper Limb assessment in Duchenne muscular dystrophy, Neuromuscular disorders 2014, 24:201-206.
Secondary Outcomes
- System usability scale (SUS)(Within 15 days from the baseline)
- 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)
Investigators
Alessandra Pedrocchi
Professor
Politecnico di Milano