Efficacy of a Rehabilitation Program With the Pediatric Exoskeleton ATLAS 2030 in Pediatric Patients With Cerebral Palsy

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 ofthe tibia) from 24cm to 33cm.

• Tibia leg length (distance from the lateral condyle of the tibia to the lateralmalleolus) 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 thebeginning 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 thedevice.

• 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 orimpossibility 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 thedevice.

• 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 lowerextremities 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 theattachment to the device.

• Conditions that provoke exercise intolerance.

• Conductual disorders that may interfere with the use of the device or theirparticipation in the study, like impulsiveness or the inability to understand simplecomands.

• Allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide,polyethylene or propylene.