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

Institut Guttmann11 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Guillain Barré Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Safety device

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

Time frame: 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)

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

Usability and satisfaction

Quest 2.0

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

Secondary Outcomes

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.