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 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT06894160
Eligibility Criteria:
Inclusion criteria related to the device characteristics:
* Weight \< 100 kg.
* Hip width between 30 - 45 cm.
* Distance from the hip joint center to the knee joint center: 36 cm - 50 cm.
* Distance from the knee joint center to the floor: 43.5 cm - 59.5 cm.
* Patients must be able to follow simple instructions.
* MAS \< 3 in lower limbs.
* EU shoe size between 36 and 45.
* Absence of pathology affecting movement (only valid for phase 1 of the current study).
Inclusion criteria related to the study:
* Age 18-85 years.
* Diagnosis of stroke (ACV), acquired brain injury (DCA), multiple sclerosis (EM), muscular dystrophy (LM), or cerebral palsy (PC).
* Gait difficulty: those who require assistance to walk using technical aids, assistance, or supervision from others.
* FAC score in participants with DCA, stroke, or MS \< 4.
* WISCI II score in participants with MD \< 20.
Exclusion Criteria:
* Spasticity (MAS) = 3 in lower limbs.
* Skin alterations in the areas of contact with the device.
* Planned surgical intervention during the study duration.
* Two or more osteoporotic fractures in the lower limbs in the last 2 years.
* Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe lung disease).
* Surgical operation in the 3 months prior to the start of the study on the limbs and/or spine.
* Psychiatric disorders that interfere with proper use of the device or participation in the study, such as impulsivity or inability to understand simple instructions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06894160
Study Brief:
Protocol Section:
NCT06894160