Actively Recruiting
A Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System
Led by ABLE Human Motion S.L. · Updated on 2026-01-27
80
Participants Needed
2
Research Sites
89 weeks
Total Duration
On this page
Sponsors
A
ABLE Human Motion S.L.
Lead Sponsor
H
Hospital Nacional de Parapléjicos de Toledo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of spinal cord injury (SCI) in the acute or subacute phase (less than 6 months since injury)
- Traumatic or non-traumatic cause of SCI
- Neurological level of SCI between C5 and L5 for AIS C or D patients, and between C7 and L5 for AIS A or B patients
- Sufficient upper extremity strength to handle a walker (triceps muscle score ≥ 4 on the Medical Research Council scale)
- Range of motion without limitations in lower extremities (at least 10 degrees knee extension and neutral ankle position)
- Muscle spasticity in lower extremities with a score ≤ 3 on the Modified Ashworth Scale
- Able to tolerate standing (have stood up in the last year)
- Aged between 18 and 70 years
- Height between 150 cm and 190 cm
- Weight less than 100 kg
You will not qualify if you...
- Walking Index for Spinal Cord Injury (WISCI) score ≥ 15
- Cognitive or neurological limitations preventing following instructions
- Other neurologic disorders permanently affecting gait and gait therapy (besides SCI)
- Grade I or higher pressure ulcers in areas contacting 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)
- Range of motion restrictions such as flexing or arthrodesis
- Spinal instability or use of spinal orthotics unless cleared by a doctor
- Deterioration greater than 3 points in motor score of ISNCSCI in last 4 weeks or new loss of sensation/motor activity above injury level not evaluated by a doctor
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Nacional de Parapléjicos
Toledo, Castille-La Mancha, Spain, 45071
Not Yet Recruiting
2
Hospital Universitario de Vall d'Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
Research Team
L
Lluïsa Montesinos Magraner, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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