Guillain Barré SyndromeAtalante GBSNCT07556809
Exoskeleton Gait Training in Guillain-Barré Syndrome: Safety, Feasibility, Usability, and Longitudinal Outcomes
A study testing Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation in people with Guillain Barré Syndrome, run by Institut Guttmann at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Guillain Barré Syndrome
- What is being tested?
- Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 7 Aug 2023to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation
- Keywords
- Guillian Barré syndrome, gait, exoskeleton
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeleton Wandercraft Atalante X, usability and gait rehabilitationDevice
Exoskeleton Wandercraft Atalante X trainning in Guillain Barre syndrome
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Wandercraft Atalante X Receives: Device: Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety device
Adverse efects, skin injuries, dizzines, bone fracture, falls.
Measured: 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)
Measured: From baseline to the Week 6 (end of intervention).
Usability and satisfaction
Quest 2.0
Measured: From baseline to the week 3 (10 session).
Secondary outcomes (5)
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.
Measured: Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start7 Aug 2023
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain Barré SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Guttmann
- Sponsor type
- University, hospital or other
- Collaborators
- Wandercraft
- Responsible party
- Sponsor
- Investigators
- Eloy E Opisso, Study director, Institut Guttmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556809
- Sponsor's protocol ID
- 2023.419
- Acronym
- Atalante GBS
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exoskeleton Gait Training in Guillain-Barré Syndrome: Safety, Feasibility, Usability, and Longitudinal Outcomes
- ClinicalTrials.gov ID
- NCT07556809
- Acronym / sponsor ID
- Atalante GBS / 2023.419
- Conditions
- Guillain Barré Syndrome
- Keywords
- Guillian Barré syndrome, gait, exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Institut GuttmannUniversity, hospital or other
- Collaborators
- Wandercraft
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Exoskeleton Wandercraft Atalante X, usability and gait rehabilitationWandercraft Atalante X |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exoskeleton Wandercraft Atalante X, usability and gait rehabilitationExoskeleton Wandercraft Atalante X trainning in Guillain Barre syndrome | Device | Intervention |
Primary outcome
Safety device
Time frame: From baseline to the Week 6(end of intervention).
Adverse efects, skin injuries, dizzines, bone fracture, falls.
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)
Usability and satisfaction
Time frame: From baseline to the week 3 (10 session).
Quest 2.0
5 secondary outcomes
Muscle Strenght
Time frame: Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
Walking speed
Time frame: Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
Aerobic capacity
Time frame: Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
Standing Balance
Time frame: Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
Functional Independence
Time frame: Baseline, Post-Intervention (Week 6), Follow-up (Week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eloy E Opisso study director
Institut Guttmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation in people with Guillain Barré Syndrome, run by Institut Guttmann at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety device (time frame: From baseline to the Week 6(end of intervention).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.