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 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT04837157
Eligibility Criteria:
Inclusion Criteria:
* Maximum user weight of 35 kg
* Thigh length (distance from the greater trochanter to the lateral condyle of the tibia) from 24 cm to 40 cm.
* Leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23 to 39 cm.
* Pelvis width (between greater trochanters) from 24 to 35 cm.
* Ability to achieve ankle dorsiflexion to 90˚
* 20º or more hip flessum.
* 20º or more knee flessum.
* No allergies to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
* Informed consent signed by legal guardians.
* Confirmed diagnosis of cerebral palsy or neuromuscular disease affecting walking ability at early development stages
* Stable medical condition with no changes in disease-specific medication in the last 6 months, and additional medication in the last month.
* Patient being followed according to the recommended standards for his or her illness
* Ability to maintain, spontaneously or with a brace, the head and trunk while standing and walking.
* No need for daytime ventilation (have an oxygen saturation and PCO2 with normal ambient oxygen
* Score on the FAC scale between 1 and 4 points
* Not being able to walk without assistance
Exclusion Criteria:
* Patient's inability to follow simple instructions and/or communicate discomfort.
* Invasive or non-invasive daytime ventilation.
* Orthostatic hypotension.
* 20º or more hip flessum.
* 20º or more knee flessum
* Scoliosis with a Cobb angle of more than 25º that cannot wear a corset during the test.
* Severe skin injury to the lower extremities.
* Scheduled surgery (spine, extremities) during the period of the study or surgery performed (spine, extremities) in the last 6 months.
* History of fracture without trauma.
* History of traumatic bone fracture in lower limbs or pelvic girdle in the last 3 months
* Not receiving regular standing rehabilitation sessions.
* Absence of control of the head or trunk in an upright position without the possibility of wearing a corset during the use of the exoskeleton
* Refusal of the patient or legal guardian to include the child in the study.
* Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the skin of patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
14 Years
Study:
NCT04837157
Study Brief:
Protocol Section:
NCT04837157