Status:
COMPLETED
Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment
Lead Sponsor:
MarsiBionics
Collaborating Sponsors:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Hospital Universitario La Paz
Conditions:
Cerebral Palsy
Acquired Brain Injury
Eligibility:
All Genders
2-17 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy. Particip...
Detailed Description
Neurological and neuromuscular diseases are the main cause of motor disability in children, leading to the inability to stand and walk in many cases. Robotic devices are a useful tool in the rehabilit...
Eligibility Criteria
Inclusion
- Diagnosis of cerebral palsy, acquired brain injury or spinal muscular atrophy
- Medical authorization for standing, gait training and weight bearing.
- Informed consent signed by legal guardians.
- Maximum user weight of 60 kg.
- Hip width (between greater trochanters) ≤40 cm.
- Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 21cm to 36cm.
- Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 20cm to 35cm.
- Shoe size ≤40 (EU)
Exclusion
- Medical contraindications for standing or walking.
- Non-reducible contractures or heterotropic ossifications above the degrees allowed by the device or out of the trajectory imposed by the device
- Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
- More than 20º of hip and/or knee non-reducible contractures at the time of using the exoskeleton.
- Necessity to walk with more than 5º of hip abduction.
- Impossibility to reach 5º of ankle dorsiflexion with ir without orthoses.
- Lower length dysmetria that cannot be mitigated with a wedge under the foot.
- Skin lesion on parts of the lower extremities that are in contact with the device.
- History of fracture without trauma.
- Presence of other conditions causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease).
- Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness.
- Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06167954
Start Date
December 4 2023
End Date
August 17 2024
Last Update
September 27 2024
Active Locations (5)
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1
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
2
Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación
Madrid, Spain, 28009
3
Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia
Madrid, Spain, 28009
4
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041