Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT
Key facts
- Who runs it
- Mario Widmer
- Where
- Nottwil, SwitzerlandSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 34 people, planned
- Started
- 18 Mar 2022
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ekso (EksoNR, Ekso Bionics)
- FES (RehaMove2, Hasomed)
- Record updated
- 18 December 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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)
Who cannot take part
- acute deep vein thrombosis
- pregnancy (tested in women of childbearing age (15 - 49 years))
- 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)
Where in Switzerland
- Swiss Paraplegic CentreNottwil, SwitzerlandContact: Mario Widmer, PhDTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Ekso and FESTreatment being tested
Participants will train for 8 weeks, 3 times per week (i.e. 24 sessions in total) for 30 minutes effective training time per session using the EksoNR powered exoskeleton combined with gait-synchronized FES using the FES RehaMove2.
Treatment: Ekso (EksoNR, Ekso Bionics) and FES (RehaMove2, Hasomed)
- Ekso without FESExisting treatment, for comparison
Participants will train for 8 weeks, 3 times per week (i.e. 24 sessions in total) for 30 minutes effective training time per session using the EksoNR powered exoskeleton without applying FES.
Treatment: Ekso (EksoNR, Ekso Bionics)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effectiveness of a Powered Exoskeleton Combined With Functional Electric Stimulation for Patients With Chronic Spinal Cord Injury: a Randomized Controlled Trial
- Record updated
- 18 December 2025