Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting

Prior treatment

• Spine or lower extremity surgery within the last 3 months

Other illness

• Unhealed fractures or history of fragility fractures in the lower extremities within the past 2 years
• Uncontrolled epileptic seizures
• Considered unsuitable by physicians and physiotherapists. Any acute medical condition such as fever, infection, respiratory problems, urinary symptoms, uncontrolled pain, new swelling or redness in the extremities, active deep vein thrombosis, or severe comorbidities considered incompatible with the use of ABLE Kids until clinical resolution

Other

• Severe spasticity in the lower limbs (Modified Ashworth Scale \[MAS\] \> 3)
• Severe osteoporosis resulting in atraumatic bone fractures
• Unstable or painful hip dislocation (Migration Percentage \[MP\] \> 50%)
• Symptomatic heterotopic ossification with mechanical limitation or pain
• Anatomical limitations incompatible with proper fitting and safe use of the device:
• Leg length discrepancy \>1.5 cm in the upper segment or \>2.0 cm in the lower segment
• Severe scoliosis (Cobb angle \>40° without the possibility of orthotic use during operation)
• Inability to achieve proper adjustment within the device
• Joint range of motion limitations preventing use of the exoskeleton:
• Knee flexion contracture ≥40°
• Hip flexion contracture ≥20°
• Rigid equinus foot
• Recently implanted pacemakers
• Inability to communicate pain, fear, or discomfort (verbally or nonverbally)
• Daytime mechanical ventilation
• Medical or cardiovascular instability
• Absence of head or trunk control in sitting or standing that cannot be compensated through the use of orthotic support during exoskeleton use

• Minors with gait impairments, ranging from mild to severe, resulting from neurological conditions or muscular weakness
• Anthropometric measurements compatible with the use of the exoskeleton, particularly:
• Weight under 75 kg
• Height between 1.0-1.5 m
• Hip: maximum distance between greater trochanters of 35 cm
• Thigh: maximum distance from trochanter to knee joint line of 36 cm
• Lower leg: maximum distance from knee joint line to shoe sole of 45 cm
• Medically stable
• Intact skin in areas in contact with the device
• Favorable medical assessment for standing, gait training, and weight-bearing activities
• Signed informed consent from parents or legal guardians, and assent from the minor whenever possible, according to age and cognitive ability