NCT05265377

Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: MarsiBionics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Gait impairment in people with acquired brain injury (ABI) and spinal cord injury (SCI) can be very heterogeneous. For this reason, STELO has been developed: a new concept of exoskeleton based on modular technology for gait assistance. It allows a personalised configuration according to the functional capacity of each patient, as the therapist can choose which robotic joints to use depending on the therapeutic goal and on the patient recovery phase. The objective is to analyse the usability of the STELO modular exoskeleton in people with ABI and SCI.

Detailed description

A test phase will be conducted in healthy volunteers as a proof of concept with the aim of evaluating safety and usability in healthy participants prior to the use of the device in the ABI or SCI population (Phase 2). After verifying that the device is safe in healthy people, phase 2 will begin: it consists of a total of 10 visits. These visits will include gait training sessions using the STELO modular exoskeleton.

Conditions

• Spinal Cord Injury
• Acquired Brain Injury

Interventions

Type	Name	Description
DEVICE	Stelo	Use of Stelo exoskeleton in nine rehabilitation sessions

Timeline

• Start date: 2022-09-21
• Primary completion: 2023-03-31
• Completion: 2023-04-30
• First posted: 2022-03-03
• Last updated: 2023-05-22

Locations

3 sites across 1 country: Spain