The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program in a clinical setting.
The secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.
Minors with gait impairments, ranging from mild to severe, resulting from neurological conditions or muscular weakness
Weight under 75 kg
Height between 1.0-1.5 m
Hip: maximum distance between greater trochanters of 35 cm
Severe spasticity in the lower limbs (MAS > 3)
Severe osteoporosis resulting in atraumatic bone fractures
Unhealed fractures or history of fragility fractures in the lower extremities within the past 2 years
Unstable or painful hip dislocation (MP > 50)
ABLE Human Motion S.L.
Lead sponsor
Som·hi Rehab
Collaborator