The primary objective of this study is to validate the safety and clinical performance of the ABLE Exoskeleton with integrated Functional Electrical Stimulation (ABLE FES) in individuals with neurological conditions that impair gait, including spinal cord injury, acquired brain injury, and multiple sclerosis.
The secondary objective is to collect preliminary data on the potential clinical and psychosocial benefits of combining robotic gait assistance with electrical stimulation.
18 to 80 years old
Diagnosis of acquired brain injury, spinal cord injury (neurological level between C5 and L2, AIS B to AIS D), or multiple sclerosis
Currently undergoing physiotherapy treatment, either as an inpatient or outpatient at the investigating center
Ability to provide informed consent
Significant osteoporosis that may increase the risk of fracture
Unresolved fractures in the pelvis or limbs, or a history of fragility fractures in the lower limbs within the past 2 years
Spinal instability (or use of spinal orthoses, unless medically approved)
Deterioration >3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and/or motor activity above the level of injury detected that has not been evaluated by a doctor.
ABLE Human Motion S.L.
Lead sponsor
therapy2people GmbH
Collaborator