Status:
NOT_YET_RECRUITING
Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.
Lead Sponsor:
MarsiBionics
Collaborating Sponsors:
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
APAC, I.A.P.
Conditions:
Neuromuscular Disorders
Neurodevelopmental Disorders
Eligibility:
All Genders
2-17 years
Phase:
NA
Brief Summary
Neurodevelopmental disorders often result in abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as the inability to stand and walk. CLINICAL EXPLORER ...
Detailed Description
Neuromuscular and neurological disorders in children cause muscle weakness and spasticity, leading to severe motor dysfunctions such as the inability to maintain posture or walk. Manually assisted gai...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Phase 0
- Age between 2 and 17 years.
- Consent from the participant or legal guardian to participate in the study.
- No diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria for Phase 1
- Age between 2 and 17 years.
- Consent from the participant or legal guardian to participate in the study.
- Diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria Related to the EXPLORER CLINICAL Device Characteristics
- Medical authorization to stand upright and perform weight-bearing gait training.
- Weight less than or equal to 60 kg.
- Hip width less than or equal to 40 cm.
- Distance from the hip joint center to the knee joint center: 21 cm - 36 cm.
- Distance from the knee joint center to the ankle joint center: 20 - 35 cm.
- EU shoe size less than or equal to 40.
- Exclusion Criteria:
- Any medical contraindication for standing or walking.
- Presence of non-reducible contractures or heterotopic ossification above the degrees allowed by the device and/or outside the trajectory imposed by the device.
- Spasticity (MAS) = 4 in lower limbs at the time of device use.
- Structured hip and/or knee contracture greater than 20 degrees.
- Inability to stand or walk with more than 5 degrees of hip abduction.
- Inability to achieve 5 degrees of dorsal ankle flexion from the neutral position with or without orthosis.
- Tibial leg length discrepancy that cannot be mitigated with the use of a foot wedge.
- Skin alterations in areas of contact with the device.
- History of fracture without trauma.
- Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe pulmonary disease).
- Behavioral disorders that interfere with proper use of the device, such as impulsivity.
- Allergy to any of the materials of the EXPLORER CLÍNICO: cotton, nylon, polyester, PPS, PEEK, or ABS. The materials used in EXPLORER CLÍNICO that were not previously used in ATLAS 2030, a medical device certified by the AEMPS, are PPS, PEEK, and ABS.
Exclusion
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07159360
Start Date
September 15 2025
End Date
June 1 2026
Last Update
September 8 2025
Active Locations (2)
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1
Asociación Pro Personas con Paralisis Cerebral (APAC-IAP)
Mexico City, Mexico City, Mexico, 06720
2
Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia
Madrid, Madrid, Spain, 28009