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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT05926635
Eligibility Criteria:
Inclusion Criteria:
* Medical authorization for standing, gait training and weight bearing.
* Informed consent signed by legal guardians.
* Confirmed diagnosis of cerebral palsy GMFCS levels III or IV.
* Proper family acceptance and commitment level.
* Receiving a minimum of 2 hours of therapy/activities promoting physical activity.
* Maximum user weight of 35 kg.
* Hip width (between greater trochanteres) less than or equal to 35 cm.
* Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 24cm to 33cm.
* Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23cm to 32cm.
* Shoe size 27-33 (EU)
Exclusion Criteria:
* More than 8 sessions of robotic therapy during a month in the previous year to the beginning of the study.
* Intensive rehabilitation during the study.
* Imposibility of the family to fulfill treatment calendar.
* 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 flessum at the time of using the exoskeleton.
* Necessity to walk with 10º of hip abduction.
* Necessity to walk with more than 9º of ankle dorsiflexion or plantar flexion or impossibility to use an orthosis to reach 90º in the ankle joint.
* Severe skin lesion on parts of the lower extremities that are in contact with the device.
* Scheduled surgery (rachis, limbs) for the duration of the study or surgery performed (rachis, extremities) in the last 6 months.
* History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
* Severe rigid orthopedic deformities of the spine and/or lower limbs.
* Cognitive or conductual disorders that may lead to a lack of adherence to the attachment to the device.
* Conditions that provoke exercise intolerance.
* Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness or the inability to understand simple comands.
* Allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
14 Years
Study:
NCT05926635
Study Brief:
Protocol Section:
NCT05926635