Evaluating the ATLAS 2030 Exoskeleton for Children with Spinal Cord Injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and usability of the ATLAS 2030 robotic gait exoskeleton in pediatric patients suffering from spinal cord injury. The study will involve ten rehabilitation sessions using the exoskeleton, along with two assessment sessions before and after the intervention. The primary focus is to determine how well the device can be integrated into a therapeutic program for improving mobility and overall well-being in children aged 3 to 14 years with spinal cord injuries. Additionally, the study will evaluate the device's impact on factors such as fatigability, mood, health perception, and gait speed.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Nacional Parapléjicos
  Toledo, Spain Recruiting

Study contacts

• Study coordinator: Carlos Cumplido Trasmonte
• Email: carlos.cumplido@marsibionics.com
• Phone: 0034 914900090

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Home neuromodulation for bladder control after spinal cord injury

  This study tests home-delivered Injectrode tibial nerve stimulation to improve bladder function in people with chronic spinal cord injury.

  Recruiting The University of Texas Health Science Center, Houston · Houston, Texas · NCT07264868

• ARC-IM therapy to help restore walking after spinal cord injury

  This study will try ARC-IM Therapy (epidural electrical stimulation) in adults with subacute or chronic traumatic spinal cord injury to see if it helps improve walking and other ambulatory functions.

  Recruiting Ecole Polytechnique Fédérale de Lausanne · Nottwil, Canton of Lucerne and 1 other locations · NCT07234903

• Transauricular vagus nerve stimulation to improve heart function after spinal cord injury

  This trial will test whether gentle electrical stimulation of the ear (taVNS) can improve heart autonomic function in adults with chronic cervical spinal cord injury who have had autonomic dysreflexia.

  Recruiting Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Ankara · NCT07007884

• Implant to improve walking after spinal cord injury

  This study is testing a special device that helps people with partial spinal cord injuries walk better by stimulating their muscles.

  Recruiting at 2 sites Louis Stokes VA Medical Center · Cleveland, Ohio and 1 other locations · NCT06965127

• Targeted spinal cord stimulation to reduce spasticity in spinal cord injury

  This study tests whether an implanted epidural stimulator can help reduce severe spasticity and improve voluntary movement in adults with spinal cord injury.

  Recruiting Kessler Foundation · West Orange, New Jersey · NCT07890558

• Spinal cord stimulation for bladder and bowel problems after spinal cord injury

  This project will test spinal cord stimulation to see if it helps people with bladder and bowel problems after a spinal cord injury.

  Recruiting Beijing Tsinghua Chang Gung Hospital · Beijing · NCT07511244

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.