NCT04837144

Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: MarsiBionics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and usability of a motorized mobility assistance exoskeleton (MAK). The procedure explores the use of the MAK exoskeleton during the static and dynamic rehabilitation sessions with the intention to evaluate the safety and usability of the device in the studied population. The protocol has been focused on defining how the device can be used appropriately in this population in a safe manner by rehabilitation specialists.The study also aims to assess the safety of clinicians implementing the intervention, as well as possible benefits derived from the use of the device. As a secondary outcome, efficacy measurements will be collected.

Conditions

• Stroke
• Gait, Hemiplegic

Interventions

Type	Name	Description
DEVICE	Physical Rehabilitation with MAK exoskeleton	The participants will assist to 9 physical rehabilitation sessions with the MAK exoskeleton. During these sessions, different movements and therapies will be conducted using the studied device.

Timeline

• Start date: 2020-10-06
• Primary completion: 2021-04-30
• Completion: 2021-06-23
• First posted: 2021-04-08
• Last updated: 2021-06-24

Locations

1 site across 1 country: Spain