NCT07036107 A Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System
| NCT ID | NCT07036107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ABLE Human Motion S.L. |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-01-15 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Lluïsa Montesinos Magraner, Dr
PRINCIPAL INVESTIGATOR
Hospital Universitario de Vall d'Hebron
Frequently Asked Questions
Who can join the NCT07036107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07036107 currently recruiting?
Yes, NCT07036107 is actively recruiting participants. Contact the research team at lluisa.montesinos@vallhebron.cat for enrollment information.
Where is the NCT07036107 trial being conducted?
This trial is being conducted at Toledo, Spain, Barcelona, Spain.
Who is sponsoring the NCT07036107 clinical trial?
NCT07036107 is sponsored by ABLE Human Motion S.L.. The principal investigator is Lluïsa Montesinos Magraner, Dr at Hospital Universitario de Vall d'Hebron. The trial plans to enroll 80 participants.