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| Name | Class |
|---|---|
| Wandercraft | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Wandercraft Atalante X |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoskeleton Wandercraft Atalante X, usability and gait rehabilitation | Device | Exoskeleton Wandercraft Atalante X trainning in Guillain Barre syndrome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety device | Adverse efects, skin injuries, dizzines, bone fracture, falls. | 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) | From baseline to the Week 6 (end of intervention). |
| Usability and satisfaction | Quest 2.0 | From baseline to the week 3 (10 session). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eloy E Opisso | Institut Guttmann | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Guttmann | Badalona | Barcelona | 08916 | Spain |
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| ID | Term |
|---|---|
| D020275 | Guillain-Barre Syndrome |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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. | 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. | 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. | 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 | Baseline, Post-Intervention (Week 6), Follow-up (Week 10) |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |