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

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.

Study Overview

• Status: Completed
• Conditions: Guillain Barré Syndrome
• Intervention / Treatment: Device: Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Institut Guttmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Wandercraft Atalante X	Device: Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation; Exoskeleton Wandercraft Atalante X trainning in Guillain Barre syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	The 10 Meter Walt test (10MWT) is primarily used to assess walking speed in meters per second, which serves as a key indicator of functional mobility, independence, and fall risk.	Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
Aerobic capacity	The 6 Minute Walk Test (6MWT) is a simple and effective assessment tool used to measure a person's aerobic capacity and endurance by evaluating the distance they can walk in six minutes.	Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
Functional Independence	The Funtional Independence Measure (FIM) is designed to evaluate the degree of disability and the assistance required for a person to perform activities of daily living (ADLs) across physical, cognitive, and social domains. The tool provides a uniform and sensitive measure of functional status, allowing clinicians to monitor progress and determine care needs	Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
Muscle Strenght	Medical Council Research. 0-5 point scale for muscle strength assessment. The muscle groups evaluated are: hip extension and flexion; knee extension and flexion; plantar and dorsal flexion. If the score is 0 it means that is no muscle contraction, and if it is 5 it means that it is able to perform the movement against resistance.The scores of all muscle groups of both legs are added together.	Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
Standing Balance	The Kansas University standing balance scale (KUSBS) quantifies postural stability. The scale design allows for precise measurement of balance, offering insights into conditions such as vertigo and contributing to new treatment approaches. If the score is 0 it means that performs 25% or less that standing activity, and if the score is 10 it means that Independently moves and retourn center of gravity in all plans greater than 2 inches.	Baseline, Post-Intervention (Week 6), Follow-up (Week 10)

Collaborators and Investigators

• Sponsor: Institut Guttmann
• Collaborators: Wandercraft
• Investigators: Study Director: Eloy E Opisso, Institut Guttmann

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Actual): December 12, 2025
• Study Completion (Actual): December 12, 2025

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: gait; exoskeleton; Guillian Barré syndrome
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Polyradiculoneuropathy; Pathological Conditions, Signs and Symptoms; Guillain-Barre Syndrome
• Other Study ID Numbers: 2023.419

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No