Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury

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

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury (SCI)
• Intervention / Treatment: Device: Rehabilitation treatment with ATLAS2030

Detailed Description

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
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlos Cumplido Trasmonte; Phone Number: 0034 914900090; Email: carlos.cumplido@marsibionics.com
• Study Contact Backup: Name: Elisa López-Dolado; Phone Number: 0034 925247700

Study Locations

• Spain
  • Toledo, Spain, 45004
    • Recruiting
    • Hospital Nacional Parapléjicos
    • Contact: Elisa, López-Dolado; Phone Number: 925247700; Email: elopez@sescam.jccm.es
    • Sub-Investigator: Raquel Madroñero-Mariscal
    • Sub-Investigator: Inés García de la Torre Soto
    • Sub-Investigator: Almudena Valiente Úbeda
    • Sub-Investigator: Ana de los Reyes Guzmán
    • Sub-Investigator: Ana Escobar Corroto
    • Principal Investigator: Elisa López-Dolado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Adequate level of acceptance and commitment from the family.

Inclusion criteria related to device characteristics:

• Weight ≤ 35 kg.
• Hip width ≤ 34 cm. It is advised that for measurements under 28 cm, verification should be performed to ensure there is no excessive base of support that might induce foot inversion in the standing position.
• Femur length (distance from the greater trochanter to the lateral condyle of the femur) between 24 cm and 33 cm. Femur lengths shorter than 24 cm are acceptable as long as the hip motor of the device does not extend above the user's iliac crest, avoiding hypermobility of the lumbar spine.
• Tibia length (distance from the lateral condyle to the lateral malleolus of the tibia) between 23 cm and 32 cm. Tibia lengths shorter than 23 cm are acceptable as long as they can be compensated with a lift and the user's ankle joint remains within the area of the ankle motor.
• EU shoe size between 27 and 33.

Exclusion Criteria:

• 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.
• Need to walk with more than 9 degrees of hip abduction.
• Need to walk with more than 9 degrees of dorsal or plantar ankle flexion, or inability to use an orthosis to achieve 90° at the ankle.
• Severe skin lesions in areas of contact with the device.
• Planned surgical intervention during the study period or previous orthopedic surgery on the spine and/or lower limbs contraindicating treatment.
• Known advanced osteoporosis evidenced by bone densitometry, particularly with a history of prior fractures or fractures without trauma. Traumatic bone fractures in the lower limbs or pelvic girdle within the past 6 months.
• Unstable fractures, joint dislocations, or other joint pathologies in the trunk and lower limbs contraindicating the treatment.
• Severe rigid orthopedic deformities of the spine that prevent the use of the device.
• Presence of frequent seizures, uncontrolled epilepsy, or difficult-to-control behavioral disorders.
• Presence of decompensated heart or lung disease, or any other condition causing exercise intolerance.
• Allergy to any of the materials used in the ATLAS 2030: cotton, nylon, polyester, polyamide, polyethylene, or polypropylene.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot Asissted Gait Training; The rehabilitation sessions will be carried out by a physiotherapist trained in rehabilitation with the ATLAS 2030 exoskeleton	Device: Rehabilitation treatment with ATLAS2030; 10 sessions of Rehabilitation Treatment with ATLAS2030 with With an evaluation session before the first session and another one after 10 sessions.; Other Names: Robot Asissted Gait rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events	occurrence of any serious adverse event to the participant	From enrollment to the last assessment session at 8 weeks
Falls prevalence	Number of falling events occurred from the participant or caregiver	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	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"	From enrollment to the last assessment session at 8 weeks
Heart rate	measurement of heart rate	from the beginning to the end of treatment at 6 weeks
Oxygen saturation	measurement of Oxygen saturation when medical prescription	from the beginning to the end of treatment at 6 weeks
Blood pressure	measurement of blood pressure. Systolic and diastolic pressures will be assessed	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	From enrollment to the last assessment session at 8 weeks
Device usage data	Total walking time. Unit of Measure: Minutes.	From enrollment to the last assessment session at 8 weeks
Number of steps	Number of steps with the device	From enrollment to the last assessment session at 8 weeks
Usage modes	two different usage modes (active and automatic).	From enrollment to the last assessment session at 8 weeks
Speed	speed achieved with the device (steps per minute)	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.	From enrollment to the last assessment session at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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.	from the beginning to the end of treatment at 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the last assessment session at 8 weeks
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	From enrollment to the last assessment session at 8 weeks
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.	From enrollment to the last assessment session at 8 weeks

Collaborators and Investigators

• Sponsor: MarsiBionics
• Collaborators: Hospital Nacional de Parapléjicos de Toledo; Fundación del Lesionado Medular

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; children; Spinal Cord Injury; robotics; Gait Exoskeleton; ATLAS2030
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: ATLAS-LM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No