Spinal Cord Injury (SCI)NCT06772077
Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury
A study testing Rehabilitation treatment with ATLAS2030 in people with Spinal Cord Injury (SCI), run by MarsiBionics at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Spinal Cord Injury (SCI)
- What is being tested?
- Rehabilitation treatment with ATLAS2030
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 17 Feb 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elisa López-Dolado contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Nacional Parapléjicos
Toledo, 45004
Elisa, López-Dolado, 925247700, elopez@sescam.jccm.es
Raquel Madroñero-Mariscal
About this study
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
Read the 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.
- Conditions
- Spinal Cord Injury (SCI)
- Being tested
- Rehabilitation treatment with ATLAS2030
- Keywords
- Spinal Cord Injury, Rehabilitation, robotics, Gait Exoskeleton, children, ATLAS2030
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation treatment with ATLAS2030Device
Also called Robot Asissted Gait rehabilitation
10 sessions of Rehabilitation Treatment with ATLAS2030 with With an evaluation session before the first session and another one after 10 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Robot Asissted Gait Training | Experimental | The rehabilitation sessions will be carried out by a physiotherapist trained in rehabilitation with the ATLAS 2030 exoskeleton Receives: Device: Rehabilitation treatment with ATLAS2030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
occurrence of any serious adverse event to the participant
Measured: From enrollment to the last assessment session at 8 weeks
Falls prevalence
Number of falling events occurred from the participant or caregiver
Measured: 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
Measured: 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"
Measured: From enrollment to the last assessment session at 8 weeks
Heart rate
measurement of heart rate
Measured: from the beginning to the end of treatment at 6 weeks
Oxygen saturation
measurement of Oxygen saturation when medical prescription
Measured: from the beginning to the end of treatment at 6 weeks
Blood pressure
measurement of blood pressure. Systolic and diastolic pressures will be assessed
Measured: 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
Measured: From enrollment to the last assessment session at 8 weeks
Device usage data
Total walking time. Unit of Measure: Minutes.
Measured: From enrollment to the last assessment session at 8 weeks
Number of steps
Number of steps with the device
Measured: From enrollment to the last assessment session at 8 weeks
Usage modes
two different usage modes (active and automatic).
Measured: From enrollment to the last assessment session at 8 weeks
Speed
speed achieved with the device (steps per minute)
Measured: 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.
Measured: From enrollment to the last assessment session at 8 weeks
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from the beginning to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start17 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo, Fundación del Lesionado Medular
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772077
- Sponsor's protocol ID
- ATLAS-LM
- Status last verified
- Aug 2025
- First submitted
- 20 Dec 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06772077
- Acronym / sponsor ID
- ATLAS-LM
- Conditions
- Spinal Cord Injury (SCI)
- Keywords
- Spinal Cord Injury, Rehabilitation, robotics, Gait Exoskeleton, children, ATLAS2030
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo, Fundación del Lesionado Medular
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot Asissted Gait Training | Experimental | Device: Rehabilitation treatment with ATLAS2030The rehabilitation sessions will be carried out by a physiotherapist trained in rehabilitation with the ATLAS 2030 exoskeleton |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation treatment with ATLAS2030Also: Robot Asissted Gait rehabilitation10 sessions of Rehabilitation Treatment with ATLAS2030 with With an evaluation session before the first session and another one after 10 sessions. | Device | Robot Asissted Gait Training |
Primary outcome
Serious Adverse Events
Time frame: From enrollment to the last assessment session at 8 weeks
occurrence of any serious adverse event to the participant
Falls prevalence
Time frame: From enrollment to the last assessment session at 8 weeks
Number of falling events occurred from the participant or caregiver
Skin integrity
Time frame: 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
Time frame: 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
Time frame: from the beginning to the end of treatment at 6 weeks
measurement of heart rate
Oxygen saturation
Time frame: from the beginning to the end of treatment at 6 weeks
measurement of Oxygen saturation when medical prescription
Blood pressure
Time frame: from the beginning to the end of treatment at 6 weeks
measurement of blood pressure. Systolic and diastolic pressures will be assessed
User and/or caregiver perception of the device
Time frame: 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
Time frame: From enrollment to the last assessment session at 8 weeks
Total walking time. Unit of Measure: Minutes.
Number of steps
Time frame: From enrollment to the last assessment session at 8 weeks
Number of steps with the device
Usage modes
Time frame: From enrollment to the last assessment session at 8 weeks
two different usage modes (active and automatic).
Speed
Time frame: From enrollment to the last assessment session at 8 weeks
speed achieved with the device (steps per minute)
Range of motion
Time frame: 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.
5 secondary outcomes
State of mind
Time frame: from the beginning to the end of treatment at 6 weeks
Health perception
Time frame: from enrollment to the last assessment session at 8 weeks
Health perception
Time frame: from enrollment to the last assessment session at 8 weeks
10 Meter Walking Test (10 MWT) measured with ATLAS 2030
Time frame: From enrollment to the last assessment session at 8 weeks
Effort perception
Time frame: from the beginning to the end of treatment at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisa López-Dolado contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation treatment with ATLAS2030 in people with Spinal Cord Injury (SCI), run by MarsiBionics at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Cumplido Trasmonte (0034 914900090, carlos.cumplido@marsibionics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: From enrollment to the last assessment session at 8 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.