Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.

Launched by ABLE HUMAN MOTION S.L. · Jul 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special wearable device called the ABLE Daily exoskeleton, which is designed to help people with spinal cord injuries walk more easily at home and in their community. The main goal is to see if this device is safe to use and how well it helps with walking in everyday settings. Participants will first receive training with the exoskeleton over three weeks at a medical center, attending nine sessions in total. After that, they will use the device on their own for 12 weeks in their homes and communities to see how it works in real life.

People who might be eligible for this study are adults with a spinal cord injury that happened more than six months ago, specifically injuries affecting the middle to lower back (between the T1 and L5 vertebrae). Participants should be able to stand and train at least three times a week, have a height between 150-200 cm (about 4’11” to 6’7”), weigh less than 100 kg (around 220 pounds), and have someone—a family member or friend—who can help them during some training sessions and at home. The study is currently looking for volunteers who can understand and agree to the study rules and who have some experience using robotic walking devices but have not used them often. This trial offers a chance for participants to learn how to safely use the exoskeleton to improve their mobility in familiar environments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • At least 18 years old
• • Chronic SCI (\>6 months)
• • Injury at levels T1 to L5 (AIS A to D)
• • Walking Index for Spinal Cord Injury (WISCI) score 0 until 9
• • Height between 150-200 cm
• • Weight less than 100 kg
• • Capable of giving informed consent on their own
• • Able to train (at least) 3 days/week
• • Able to have at least 1 companion / buddy who can attend a minimum of two of the training sessions, besides the final assessment, and who will learn how to assist them at home and in the community (ideally two companions)
• • Proficiency in walking with the ABLE Exoskeleton
• • At least 8 weeks with minimal use (less than 5 sessions) of wearable robotic exoskeletons for gait assistance at the start of the study.
• Exclusion Criteria:
• • High risk of fractures due to osteoporosis, a dual energy X-ray absorptiometry (DEXA)-scan at the hip, distal femur, and proximal tibia BMD score
• • Fragility fractures of the lower limbs in the last 2 years
• • Deterioration \>3 in the International Standards for Neurological Classification of SCI (ISNCSCI) score in the last 4 weeks
• • Spinal instability, like spondylolisthesis
• • Disorders of the arms and hands that make walking with crutches impossible
• • Modified Ashworth Scale (MAS) \>3 in lower limbs
• • Cardiovascular health issues which prevent the participant from training
• • Instability to tolerate 10 minutes of standing without clinical symptoms of orthostatic hypotension
• • Psychological, cognitive issues, or any other condition that does not allow a participant to follow study procedures
• • Medically unstable due to severe comorbidities, including any condition that a physician deems inappropriate for completing study participation
• • Skin problems in areas that would be in contact with the device
• • Height, width, weight, or other anatomical limitations (such as differences in leg length) incompatible with the device
• • Insufficient joint range of motion (ROM) for the device
• • Known pregnancy