A Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System

This clinical trial aims to collect evidence on the clinical benefits and the socioeconomic impact of integrating a novel wearable powered lower-limb exoskeleton for gait rehabilitation in acute/subacute spinal cord injured individuals and to evaluate the efficiency of this technology to the current standard of care in the Spanish Healthcare System (SNS).. The main questions it aims to answer are: * Is robotic therapy for gait rehabilitation more effective and efficient than conventional therapy? * Does robotic therapy for gait rehabilitation reduce the burden on healthcare professionals and caregivers? * Does robotic therapy for gait rehabilitation reduce direct healthcare costs? * Does robotic therapy for gait rehabilitation reduce intervention-related costs? Researchers will compare a novel wearable powered lower-limb exoskeleton for gait rehabilitation to conventional therapy to see if the robotic exoskeleton is more effective and efficient in improving clinical benefits and to assess if it reduces the burden of healthcare professionals and caregivers, as well as healthcare and intervention-related costs. Participants will: * Be randomized on a 1:1 basis to receive rehabilitation treatment with either the robotic exoskeleton or conventional therapy for gait recovery, 3 times a week on non-consecutive days for 8 weeks (24-session program). * Undergo a pre- and post-intervention assessment of clinical, functional, physiological, psychological, and socioeconomic variables. * Have a follow-up visit 2 months after the end of the treatment.

NCT Number	NCT07036107
Lead Sponsor	ABLE Human Motion S.L. Collaborators: Hospital Nacional de Parapléjicos de Toledo, Universitat de Lleida, Hospital Universitari Vall d'Hebron Research Institute
Conditions	Spinal Cord Injury
Enrollment	80 participants
Start Date	2026-01-15
Primary Completion	2027-09-30 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-27