Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMario Widmer

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

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mario Widmer

Lead sponsor

Swiss Paraplegic Research, Nottwil

Sponsor institution