The goal of this clinical trial is to analyze the usability and safety of the robotic gait ATLAS 2030 in a cohort of pediatric patients with Spinal Cord Injury, with the aim of extending its indication for use to pediatric spinal cord injury
Having a subacute or chronic spinal cord injury (SCI) and being clinically stable with a general condition good enough to participate in the therapeutic program with the ATLAS 2030.
Age between 3 and 14 years.
Medical authorization to perform standing and gait training with weight-bearing.
Consent from the participant or legal guardian to participate in the study.
Impossibility for the family to complete treatment schedule planning.
Any contraindication for standing and/or walking.
Spasticity (Modified Ashworth Scale (MAS) = 4 in the lower limbs at the time of device use).
Joint contracture of the hip and/or knee > 20 degrees.
Single group
Rehabilitation treatment with ATLAS2030
Device10 sessions of Rehabilitation Treatment with ATLAS2030 with With an evaluation session before the first session and another one after 10 sessions.
Serious Adverse Events
occurrence of any serious adverse event to the participant
Falls prevalence
Number of falling events occurred from the participant or caregiver
Skin integrity
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Pain assessment
pain measured by the Visual Analogic Scale (VAS) by the participant, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain"
State of mind
It will be done with a Likert-type scale from 1 to 5 (1: very sad; 2: sad; 3: indifferent; 4: happy; 5: very happy). This scale will be administered before and after each therapeutic session.
Health perception
EQ-5D scale assesses five dimensions of health: Mobility, Self-care, Usual activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five levels of severity (No problems, Slight problems, Moderate problems, Severe problems, and Extreme problems).
Health perception
Visual Analogue Scale (VAS) is a vertical scale where patients rate their current health on a scale from 0 to 100 (0 representing "the worst health you can imagine" and 100 representing "the best health you can imagine.
10 Meter Walking Test (10 MWT) measured with ATLAS 2030
The 10 Meter Walking Test (10MWT) records the time taken by the participant to walk 10 meters with the device in motion intent mode.
Classification of Spinal Cord Injury
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is a standardized tool for assessing and classifying spinal cord injuries Sensory function: Assessed in 28 dermatomes per side for light touch and pinprick sensations, scored as 0 (absent), 1 (impaired), or 2 (normal). Maximum score: 224 points (112 per modality). Motor function: Evaluated in 10 key muscle groups per side, using a 0-5 strength scale. Maximum score: 100 points. ASIA Impairment Scale: Classifies the severity of spinal cord injury into five categories: from A (complete) to E (normal).
Disability
The Spinal Cord Independence Measure (SCIM) III. It is composed of 19 items that assess three main domains: * Self-care (6 items, scores range from 0-20) * Respiration and sphincter management (4 items, scores range from 0-40) * Mobility (9 items, scores range from 0-40) The total SCIM scores range from 0 to 100
Walking ability
WISCI II (Walking Index for Spinal Cord Injury): Assess walking ability and level of assistance needed. Scoring: 0: Cannot walk. 20: Independent walking. Intermediate (1-19): Varies with assistive devices.
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MarsiBionics
Lead sponsor
Hospital Nacional de Parapléjicos de Toledo
Collaborator
Fundación del Lesionado Medular
Collaborator
