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

RecruitingNAAges 18 Years - anyAllMario Widmer
NCT05187650 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * intact lower motoneuron on the segmental innervation level of M. glutaeus maximus, Mm. ischiocrurales, M. tibialis anterior and M. quadriceps (to guarantee the stimulability with FES) Exclusion Criteria: * 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 * spasticity (modified Ashworth Scale \>3) * skin injuries of the lower limbs in areas where the skin has contact with the exoskeleton * Unstable circulation (unable to stand for at least 10 minutes) * acute deep vein thrombosis * pregnancy (tested in women of childbearing age (15 - 49 years))
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What it tests

  • Ekso (EksoNR, Ekso Bionics)
  • FES (RehaMove2, Hasomed)
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Where

1 site
Swiss Paraplegic Centre
Nottwil, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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