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:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT06645795
Eligibility Criteria:
Inclusion Criteria:
* Pediactric population with neurodevelopmental disorders who have been diagnosed with cerebral palsy.
* With a level IV or V of the GMFCS.
* Adapted to the school environment (\> 6 months).
* Unable to stand without support.
* Receiving conventional physiotherapy (\> 6 months).
* Receiving a standing program (standing duration at school: at least 45 minutes/day).
* With ankle orthosis.
* Meeting the specific criteria of the exoskeleton manufacturer (ATLAS 2030 Marsibionics https://www.marsibionics.com/): Weight less than 35 kg, Hip width less than 35 cm, Distance from the center of rotation of the hip to that of the knee between 24 and 33 cm, distance from the center of rotation of the knee to that of the ankle between 23 and 32 cm, the ankle can reach close to 90º with or without an orthosis, shoe size less than 33, hip and knee flexion less than or equal to 20º (even after having previously warmed up).
Exclusion Criteria:
* Severe spinal deformity.
* Severe hip dysplasia.
* Knee and hip flexion greater than 20º.
* Children treated surgically within the 1-year period prior to the evaluation date.
* Skin inflammation and open skin lesions around the trunk or limbs.
* Uncontrolled epilepsy: active epilepsy resistant to medication.
* Pacemaker, defibrillator or osteosynthesis material carriers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
16 Years
Study:
NCT06645795
Study Brief:
Protocol Section:
NCT06645795