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

NCT06772077 | Recruiting DMC

• 1 other identifier: ATLAS-LM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injury (SCI)

Keywords

Spinal Cord Injury; Rehabilitation; robotics; Gait Exoskeleton; children; ATLAS2030

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (5)

• State of mind

  from the beginning to the end of treatment at 6 weeks

• Health perception

  from enrollment to the last assessment session at 8 weeks

• Health perception

  from enrollment to the last assessment session at 8 weeks

• 10 Meter Walking Test (10 MWT) measured with ATLAS 2030

  From enrollment to the last assessment session at 8 weeks

• Effort perception

  from the beginning to the end of treatment at 6 weeks

Other Outcomes (3)

• Classification of Spinal Cord Injury

  From enrollment to the last assessment session at 8 weeks

• Disability

  From enrollment to the last assessment session at 8 weeks

• Walking ability

  From enrollment to the last assessment session at 8 weeks

Study Arms (1)

Robot Asissted Gait Training

EXPERIMENTAL

The rehabilitation sessions will be carried out by a physiotherapist trained in rehabilitation with the ATLAS 2030 exoskeleton

Device: Rehabilitation treatment with ATLAS2030

Interventions

Rehabilitation treatment with ATLAS2030 DEVICE

10 sessions of Rehabilitation Treatment with ATLAS2030 with With an evaluation session before the first session and another one after 10 sessions.

Also known as: Robot Asissted Gait rehabilitation

Robot Asissted Gait Training

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MarsiBionics: lead
• Hospital Nacional de Parapléjicos de Toledo: collaborator
• Fundación del Lesionado Medular: collaborator

Study Sites (1)

Hospital Nacional Parapléjicos

Toledo, 45004, Spain

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Carlos Cumplido Trasmonte

CONTACT

0034 914900090; carlos.cumplido@marsibionics.com

Elisa López-Dolado

CONTACT

0034 925247700

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 13, 2025
• Study Start: February 17, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

ES (1)