NCT05187650: Ekso-FES

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

Recruiting now NA Last updated 18 December 2025

What this trial tests

NA trial testing Ekso (EksoNR, Ekso Bionics) in Spinal Cord Injuries in 34 participants. Currently enrolling.

Timeline

18 March 2022

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	Mario Widmer
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	34
Start date	18 March 2022
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	1 location across Switzerland

Drugs / interventions tested

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

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Gait Disorders, Neurologic — all drugs for Gait Disorders, Neurologic →

Sponsor

Mario Widmer

Who can join

18 and older, any sex, with Spinal Cord Injuries or Gait Disorders, Neurologic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710
2. Influence of gait-synchronized functional electrical stimulation during exoskeleton-assisted ambulation on cardiorespiratory outcomes in individuals with incomplete spinal cord injury.
   Voicu R, Kuchen DB, Perret C, Bersch I, et al · · 2025 · PMID 41178133 · DOI 10.2340/jrm.v57.43423