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

Not Applicable

Recruiting

• Conditions: Spinal Cord Injury (SCI)

• Registration Number: NCT06772077
• Lead Sponsor: MarsiBionics

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

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 Timeline

• Study First Submitted: 2024-12-20
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-13
• Study Start: 2025-02-17
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-02
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
User and/or caregiver perception of the device	From enrollment to the last assessment session at 8 weeks	Questions that are scored from 0 to 5 on aspects related to comfort, weight, volume, etc
Device usage data	From enrollment to the last assessment session at 8 weeks	Total walking time. Unit of Measure: Minutes.
Number of steps	From enrollment to the last assessment session at 8 weeks	Number of steps with the device
Serious Adverse Events	From enrollment to the last assessment session at 8 weeks	occurrence of any serious adverse event to the participant
Falls prevalence	From enrollment to the last assessment session at 8 weeks	Number of falling events occurred from the participant or caregiver
Skin integrity	From enrollment to the last assessment session at 8 weeks	Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Pain assessment	From enrollment to the last assessment session at 8 weeks	pain measured by the Visual Analogic Scale (VAS) by the participant, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain"
Heart rate	from the beginning to the end of treatment at 6 weeks	measurement of heart rate
Oxygen saturation	from the beginning to the end of treatment at 6 weeks	measurement of Oxygen saturation when medical prescription
Blood pressure	from the beginning to the end of treatment at 6 weeks	measurement of blood pressure. Systolic and diastolic pressures will be assessed
Usage modes	From enrollment to the last assessment session at 8 weeks	two different usage modes (active and automatic).
Speed	From enrollment to the last assessment session at 8 weeks	speed achieved with the device (steps per minute)
Range of motion	From enrollment to the last assessment session at 8 weeks	Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º.

Secondary Outcome Measures

Name	Time	Method
State of mind	from the beginning to the end of treatment at 6 weeks	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	from enrollment to the last assessment session at 8 weeks	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	From enrollment to the last assessment session at 8 weeks	The 10 Meter Walking Test (10MWT) records the time taken by the participant to walk 10 meters with the device in motion intent mode.
Effort perception	from the beginning to the end of treatment at 6 weeks	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.

Trial Locations

Locations (1)

Hospital Nacional Parapléjicos; 🇪🇸 Toledo, Spain