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

Launched by ABLE HUMAN MOTION S.L. · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of robotic device called a wearable exoskeleton, which helps people with recent spinal cord injuries learn to walk again. The researchers want to find out if this robotic therapy works better and is more efficient than the usual physical therapy used in Spain’s healthcare system. They are also looking at whether using the exoskeleton can reduce the workload for healthcare workers and caregivers, and if it can lower healthcare costs.

People who may join the study are adults aged 18 to 70 who have had a spinal cord injury within the last six months and meet certain physical requirements, like enough arm strength to use a walker and the ability to stand up. Participants will be randomly assigned to either use the robotic exoskeleton or receive regular walking therapy, three times a week for eight weeks. The study will check their progress before and after treatment, as well as two months later, looking at their physical, emotional, and daily life improvements. This trial could help improve walking recovery options for people with spinal cord injuries while also easing the demands on caregivers and healthcare services.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • diagnosis of spinal cord injury (SCI) in the acute or subacute phase (\< 6 months of evolution)
• • traumatic or non-traumatic aetiology
• • neurological level of the SCI between C5 and L5 for patients with American Spinal Injury Association Impairment Scale (AIS) C or D, and SCI between C7 and L5 for patients with AIS A or B.
• • sufficient strength in the upper extremities to handle a walker (triceps muscle score ≥ 4 according to the Medical Research Council (MRC) scale).
• • range of motion (ROM) without limitations in the lower extremities (achieve at least a knee extension of 10 degrees and neutral ankle position)
• • muscle spasticity in the lower extremities with a score ≤ 3 on the Modified Ashworth Scale (MAS)
• • tolerate bipedalism (having stood up in the last year)
• • aged between 18 and 70 years, with height between 150 cm and 190 cm, and weight less than 100 kg
• Exclusion Criteria:
• • WISCI ≥ 15
• • cognitive or neurological limitations that prevent following instructions
• • another neurologic disorder permanently affecting gait and gait therapy (other than SCI)
• • grade I or higher in the European Pressure Ulcer Advisory Panel (EPUAP) in the areas of contact with the exoskeleton
• • unresolved fractures at the time of the study
• • uncontrolled autonomic dysautonomia
• • intolerance to exercise
• • uncontrolled epilepsy
• • previous experience with Robotic-Assisted Gait Training (RAGT).
• • ROM restriction such as flexing or arthrodesis will be excluded
• • spinal instability (or spinal orthotics unless cleared by a medical doctor).
• • 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.