Exoskeleton Gait Training in Guillain-Barré Syndrome: Safety, Feasibility, Usability, and Longitudinal Outcomes

The main objective of the study is to determine if the Atalante X exoskeleton by Wandercraft is a safe, reliable, and usable device for people with Guillain-Barré Syndrome (GBS) who are unable to walk. The secondary objective is to assess the impact of using this device on the gait and functional recovery of this type of users (GBS). The users undergo 20 training sessions over 6 weeks. Assessments are carried out at baseline, post-intervention, and at a 4-week follow-up after completing the training sessions. In all assessments, the same outcomes is conducted using the Medical Research Council Outcome, 10-Meter Walk Test, 6-Minute Walking Test, Kansas University Standing Balance Scale, Functional Independence Measure and Level of Assistence. To assess satisfaction, the QUEST 2.0 scale is administered. During this 20 sessions, monitoring is conducted for possible adverse effects that may appear and for the time required for donning and doffing the device.

NCT Number	NCT07556809
Lead Sponsor	Institut Guttmann Collaborators: Wandercraft
Conditions	Guillain Barré Syndrome
Enrollment	11 participants
Start Date	2023-08-07
Primary Completion	2025-12-12 (estimated)
Study Completion	2025-12-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-08