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

NCT07556809 | Completed

• 1 other identifier: 2023.419
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Guillain Barré Syndrome

Keywords

Guillian Barré syndrome; gait; exoskeleton

Outcome Measures

Primary Outcomes (3)

• Safety device

  Adverse efects, skin injuries, dizzines, bone fracture, falls.

  From baseline to the Week 6(end of intervention).

• Fesability

  Steps per session, standing time, attendance, and donning/doffing time (Including the transfer time from the wheelchair)

  From baseline to the Week 6 (end of intervention).

• Usability and satisfaction

  Quest 2.0

  From baseline to the week 3 (10 session).

Secondary Outcomes (5)

• Muscle Strenght

  Baseline, Post-Intervention (Week 6), Follow-up (Week 10)

• Walking speed

  Baseline, Post-Intervention (Week 6), Follow-up (Week 10)

• Aerobic capacity

  Baseline, Post-Intervention (Week 6), Follow-up (Week 10)

• Standing Balance

  Baseline, Post-Intervention (Week 6), Follow-up (Week 10)

• Functional Independence

  Baseline, Post-Intervention (Week 6), Follow-up (Week 10)

Study Arms (1)

Intervention

EXPERIMENTAL

Wandercraft Atalante X

Device: Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation

Interventions

Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation DEVICE

Exoskeleton Wandercraft Atalante X trainning in Guillain Barre syndrome

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Guillain Barre syndrome
• Receiving outpatient care and admitted at Institut Guttmann
• Able to provide written informed consent
• Unable to walk (FAC 0-1).

You may not qualify if:

• Ability to walk \>10 m without physical assistance or walking aids
• History of lower-limb fragility fracture within the previous 2 years
• Inability to tolerate 30 minutes of standing without clinical symptoms of orthostatic hypotension
• Psychological or cognitive impairment preventing adherence to study procedures
• Medical instability or severe comorbidities deemed by a physician to contraindicate participation
• Skin lesions in areas in contact with the device
• Anthropometric or anatomical constraints incompatible with the exoskeleton (e.g., height, width, weight, or relevant leg-length discrepancies)
• Insufficient range of motion (ROM) for safe use of the Atalante™ exoskeleton
• Known pregnancy or breastfeeding.

Sponsors & Collaborators

• Institut Guttmann: lead
• Wandercraft: collaborator

Study Sites (1)

Institut Guttmann

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eloy E Opisso

  Institut Guttmann

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 29, 2026
• Study Start: August 7, 2023
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

ES (1)