Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT07159360
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT07159360
Study Brief:
Protocol Section:
NCT07159360