Guillain Barré Syndrome
Conditions
Keywords
Guillian Barré syndrome, gait, exoskeleton
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.
Interventions
DEVICEExoskeleton Wandercraft Atalante X, usability and gait rehabilitation
Exoskeleton Wandercraft Atalante X trainning in Guillain Barre syndrome
Sponsors
Institut Guttmann
Wandercraft
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety device | From baseline to the Week 6(end of intervention). | Adverse efects, skin injuries, dizzines, bone fracture, falls. |
| Fesability | 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 | From baseline to the week 3 (10 session). | Quest 2.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strenght | 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. |
| Walking speed | 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. |
| Aerobic capacity | 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. |
| Standing Balance | 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. |
| Functional Independence | 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 |
Countries
Spain
Contacts
STUDY_DIRECTOREloy E Opisso
Institut Guttmann
Outcome results
None listed