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Completed

NCT Number: NCT07556809

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Guttmann

Badalona, Barcelona, 08916, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation

Device

Exoskeleton Wandercraft Atalante X trainning in Guillain Barre syndrome

Primary outcomes

  1. Safety device

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

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

  2. Fesability

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

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

  3. Usability and satisfaction

    Time frame: From baseline to the week 3 (10 session).

    Quest 2.0

Secondary outcomes

  1. Muscle Strenght

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

    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.

  2. Walking speed

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

    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.

  3. Aerobic capacity

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

    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.

  4. Standing Balance

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

    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.

  5. Functional Independence

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

    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

Sponsors and collaborators

Lead sponsor

Institut Guttmann

Other

Collaborators

  • Wandercraft

Registry information

Acronym: Atalante GBS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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