Exoskeleton Gait Training in Guillain-Barré Syndrome: Safety, Feasibility, Usability, and Longitu… (NCT07556809) | Clinical Trial Compass
CompletedNot Applicable
Exoskeleton Gait Training in Guillain-Barré Syndrome: Safety, Feasibility, Usability, and Longitudinal Outcomes
Spain11 participantsStarted 2023-08-07
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety device
Timeframe: From baseline to the Week 6(end of intervention).
2
Fesability
Timeframe: From baseline to the Week 6 (end of intervention).
3
Usability and satisfaction
Timeframe: From baseline to the week 3 (10 session).