About this trial
The goal of this clinical trial is to to confirm the safety and performance of the ABLE Daily to perform ambulatory functions in home and community settings for people with spinal cord injury.
The experimental period will cover the training period with the ABLE Daily exoskeleton (3 weeks of use at the investigational site with a total of 9 sessions) and the home period (12 weeks of personal use at home and community environments).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ABLE Daily
Treatment groups
Sponsors and collaborators
ABLE Human Motion S.L.
Lead sponsor
Sint Maartenskliniek
Collaborator
Universitat Politècnica de Catalunya
Collaborator