About this trial
While there are a number of prospective studies evaluating powered exoskeletons in SCI patients, to date, not a single well-designed, randomized clinical trial has been published. However, there is evidence for beneficial effects of over-ground exoskeleton therapy on walking function post-intervention from a meta-analysis on non-randomized, uncontrolled studies. Functional electrical stimulation (FES), on the other hand, is a common and established method for the rehabilitation of persons with SCI and has been demonstrated to be beneficial in, e.g., improving muscle force, power output and endurance.
Combining FES and overground robotic therapy within the same therapy session could potentially merge and potentiate the effects of each separate treatment, making it a very powerful and efficient therapy method. Up to date, however, comparative studies evaluating benefits of this combined approach (i.e., powered exoskeleton and FES) to robotic therapy without FES are missing.
Eligibility criteria
Qualifiers
chronic, incomplete SCI (> 1 year, AIS B-D)
traumatic or non-traumatic lesion
capacity to stand up and perform a 10MWT with or without medical aids
partially wheelchair dependent
Disqualifiers
Exoskeleton device related contraindications: > 100 kg body weight; Body height: < 155 cm or > 190 cm; pelvic width: > 46 cm
orthopedic limitations (acute fractures of the lower limb)
contractures
heterotrophic ossification
Trial design
Treatments tested in this trial
- Ekso (EksoNR, Ekso Bionics)
- FES (RehaMove2, Hasomed)
Treatment groups
Sponsors and collaborators
Mario Widmer
Lead sponsor
Swiss Paraplegic Research, Nottwil
Sponsor institution