Actively Recruiting
Robotic-SNS: A Randomized 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
N/A
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 trial studies adults aged 18 to 70 with recent spinal cord injuries to compare a new robotic wearable exoskeleton for walking rehabilitation against conventional therapy. It aims to find out if robotic therapy improves walking ability and reduces healthcare and caregiver burden and costs more effectively than standard care within the Spanish Healthcare System. Participants will be randomly assigned to receive either the ABLE Exoskeleton or conventional therapy involving joint mobilization, muscle strengthening, and walking re-education with aids. Both groups undergo 24 rehabilitation sessions, three times a week, over 8 weeks. Assessments take place before, during, and after treatment, with a follow-up 2 months later. During the study, participants will have clinical, functional, physiological, psychological, and socioeconomic evaluations including walking ability, balance, motor scores, endurance, bladder/bowel function, pain, spasticity, and quality of life. Caregiver burden and healthcare costs are also measured. Safety and progress are monitored at multiple timepoints up to 2 months post-treatment.
CONDITIONS
Brief 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 in the acute or subacute phase (less than 6 months)
- Traumatic or non-traumatic cause
- Neurological level between C5 and L5 for AIS C or D, and between C7 and L5 for AIS A or B
- Sufficient upper limb strength to handle a walker (triceps muscle score 4 or higher)
- Lower limb range of motion without limitations (at least 10 degrees knee extension and neutral ankle position)
- Muscle spasticity in lower limbs with a score of 3 or less on the Modified Ashworth Scale
- Ability to tolerate standing (stood up in the last year)
- Age 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 or higher
- Cognitive or neurological impairments preventing following instructions
- Other neurological disorders affecting gait aside from spinal cord injury
- Grade 1 or higher pressure ulcers in areas contacting the exoskeleton
- Unhealed fractures
- Uncontrolled autonomic dysautonomia
- Exercise intolerance
- Uncontrolled epilepsy
- Prior experience with Robotic-Assisted Gait Training
- Range of motion restrictions such as flexing or arthrodesis
- Spinal instability or spinal orthotics unless medically cleared
- Recent deterioration of more than 3 points in motor score or new sensation/motor loss above injury level not evaluated by a doctor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants are randomly assigned to receive rehabilitation treatment with either the ABLE Exoskeleton or conventional therapy for gait rehabilitation.
3 visits per week for up to 8 weeks (total of 24 sessions) including assessments at mid-training (12 sessions) and end of training (24 sessions)
Duration - 2 months after treatment
Participants have a follow-up visit two months after the end of the rehabilitation treatment to assess ongoing outcomes including caregiver burden.
1 visit (in-person)
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
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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