Actively Recruiting
Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT
Led by Mario Widmer · Updated on 2025-12-18
34
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic, incomplete spinal cord injury for more than 1 year with AIS B-D classification
- Traumatic or non-traumatic spinal cord lesion
- Ability to stand up and perform a 10-meter walk test with or without medical aids
- Partially dependent on a wheelchair
- Intact lower motor neurons at specific muscle segments to allow stimulation with FES
You will not qualify if you...
- Body weight over 100 kg, height less than 155 cm or over 190 cm, pelvic width over 46 cm
- Orthopedic issues such as acute lower limb fractures
- Joint contractures
- Heterotrophic ossification
- Spasticity greater than 3 on the modified Ashworth Scale
- Skin injuries on lower limbs where the exoskeleton contacts the skin
- Unstable circulation preventing standing for at least 10 minutes
- Acute deep vein thrombosis
- Pregnancy (tested in women aged 15 to 49 years)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, Switzerland, 6207
Actively Recruiting
Research Team
M
Mario Widmer, PhD
CONTACT
I
Ines Bersch, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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