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
Spinal cord injury has a relatively low prevalence in the pediatric population, although its effects have significant physical and psychological consequences that greatly impact the quality of life of affected children. The ATLAS 2030 exoskeleton is a robotic gait device approved by the Spanish Agency of Medicines and Medical Devices for the rehabilitation of pediatric patients with cerebral palsy and spinal muscular atrophy. The principal aim is to analyze the safety and usability of the ATLAS 2030 exoskeleton during the implementation of a robotic gait training program with this device in a cohort of pediatric patients with spinal cord injury. the secondary aim is to analyze, in the same cohort of pediatric patients with spinal cord injury and through the implementation of the same therapeutic program, the efficacy of the ATLAS 2030 exoskeleton in improving fatigability, mood, health perception, and gait speed. Ten sessions with the ATLAS 2030 exoskeleton will be conducted with pediatric patients with acute or chronic spinal cord injury. Additionally, two assessment sessions will be performed before and after the series of sessions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
10 sessions of Rehabilitation Treatment with ATLAS2030 with With an evaluation session before the first session and another one after 10 sessions.
Hospital Nacional Parapléjicos
Toledo, Spain
RECRUITINGSerious Adverse Events
occurrence of any serious adverse event to the participant
Time frame: From enrollment to the last assessment session at 8 weeks
Falls prevalence
Number of falling events occurred from the participant or caregiver
Time frame: From enrollment to the last assessment session at 8 weeks
Skin integrity
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Time frame: From enrollment to the last assessment session at 8 weeks
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"
Time frame: From enrollment to the last assessment session at 8 weeks
Heart rate
measurement of heart rate
Time frame: from the beginning to the end of treatment at 6 weeks
Oxygen saturation
measurement of Oxygen saturation when medical prescription
Time frame: from the beginning to the end of treatment at 6 weeks
Blood pressure
measurement of blood pressure. Systolic and diastolic pressures will be assessed
Time frame: from the beginning to the end of treatment at 6 weeks
User and/or caregiver perception of the device
Questions that are scored from 0 to 5 on aspects related to comfort, weight, volume, etc
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Time frame: From enrollment to the last assessment session at 8 weeks
Device usage data
Total walking time. Unit of Measure: Minutes.
Time frame: From enrollment to the last assessment session at 8 weeks
Number of steps
Number of steps with the device
Time frame: From enrollment to the last assessment session at 8 weeks
Usage modes
two different usage modes (active and automatic).
Time frame: From enrollment to the last assessment session at 8 weeks
Speed
speed achieved with the device (steps per minute)
Time frame: From enrollment to the last assessment session at 8 weeks
Range of motion
Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º.
Time frame: From enrollment to the last assessment session at 8 weeks
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.
Time frame: from the beginning to the end of treatment at 6 weeks
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).
Time frame: from enrollment to the last assessment session at 8 weeks
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.
Time frame: from enrollment to the last assessment session at 8 weeks
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.
Time frame: From enrollment to the last assessment session at 8 weeks
Effort perception
Borg Rating of Perceived Exertion (RPE), is a tool used to measure the intensity of physical activity based on how hard you feel your body is working. \- Modified Borg Scale (0-10): This version ranges from 0 to 10, where 0 means "nothing at all" and 10 means "very, very hard." It's often used in clinical settings to assess symptoms like breathlessness, chest pain, and muscle fatigue.
Time frame: from the beginning to the end of treatment at 6 weeks