Study on the Effects and Cost Benefits of Wearable Exoskeletons for Walking Rehabilitation in Spinal Cord Injury Patients in Spain

What this Trial Is About

This trial studies adults aged 18 to 70 with recent spinal cord injuries to compare a new robotic wearable exoskeleton for walking rehabilitation against conventional therapy. It aims to find out if robotic therapy improves walking ability and reduces healthcare and caregiver burden and costs more effectively than standard care within the Spanish Healthcare System. Participants will be randomly assigned to receive either the ABLE Exoskeleton or conventional therapy involving joint mobilization, muscle strengthening, and walking re-education with aids. Both groups undergo 24 rehabilitation sessions, three times a week, over 8 weeks. Assessments take place before, during, and after treatment, with a follow-up 2 months later. During the study, participants will have clinical, functional, physiological, psychological, and socioeconomic evaluations including walking ability, balance, motor scores, endurance, bladderbowel function, pain, spasticity, and quality of life. Caregiver burden and healthcare costs are also measured. Safety and progress are monitored at multiple timepoints up to 2 months post-treatment.

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