Wearable exoskeleton-assisted walking for people with recent spinal cord injury in Spanish hospitals
Robotic-SNS: A Multicenter, Randomized Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System
This trial will test whether a wearable powered lower-limb exoskeleton helps people with recent spinal cord injury walk better and lowers caregiver and healthcare costs compared with conventional therapy in Spain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | ABLE Human Motion S.L. Industry-sponsored |
| Locations | 2 sites (Toledo, Castille-La Mancha and 1 other locations) |
| Trial ID | NCT07036107 on ClinicalTrials.gov |
What this trial studies
Adults with acute or subacute spinal cord injury will be randomly assigned to 24 sessions of gait rehabilitation using the ABLE wearable exoskeleton or to conventional gait therapy. The open, parallel-group design includes baseline, mid-training (after 12 sessions), end-training (after 24 sessions), and a two-month follow-up visit. Outcomes include clinical gait and function measures plus socioeconomic endpoints such as direct healthcare costs, intervention-related costs, and caregiver burden. Participants are recruited at Vall d'Hebron University Hospital (Barcelona) and the National Hospital for Paraplegics (Toledo) within the Spanish National Health System.
Who should consider this trial
Good fit: Adults aged 18–70 with traumatic or non‑traumatic spinal cord injury in the acute/subacute phase (<6 months), meeting device size/weight and strength requirements (upper-limb strength to use a walker, ROM and spasticity limits) and the protocol's neurological level/AIS criteria.
Not a fit: People who are outside the device height/weight limits, have severe cognitive or neurological impairments preventing participation, have very high baseline walking ability (WISCI ≥ 15), or chronic injuries beyond the allowed timeframe are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the exoskeleton could improve walking outcomes while reducing caregiver strain and healthcare costs for people with recent spinal cord injury.
How similar studies have performed: Prior research with powered exoskeletons has shown promising improvements in gait and mobility but head-to-head socioeconomic comparisons versus conventional therapy remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toledo, Castille-La Mancha and 1 other locations
- Hospital Nacional de Parapléjicos — Toledo, Castille-La Mancha, Spain (Not_yet_recruiting)
- Hospital Universitario de Vall d'Hebron — Barcelona, Catalonia, Spain (Recruiting)
Study contacts
- Principal investigator: Lluïsa Montesinos Magraner, Dr — Hospital Universitario de Vall d'Hebron
- Study coordinator: Lluïsa Montesinos Magraner, Dr
- Email: lluisa.montesinos@vallhebron.cat
- Phone: +34 620951308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.