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RECRUITING
NCT05187650
NA

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

Sponsor: Mario Widmer

View on ClinicalTrials.gov

Summary

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.

Official title: Effectiveness of a Powered Exoskeleton Combined With Functional Electric Stimulation for Patients With Chronic Spinal Cord Injury: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2022-03-18

Completion Date

2027-12-31

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

DEVICE

Ekso (EksoNR, Ekso Bionics)

The EksoNR is a powered exoskeleton designed to be used in a rehabilitation setting. The device meets the provision of the Council Directive 93/42/EEC concerning medical devices and is used for gait training in neurorehabilitation.

DEVICE

FES (RehaMove2, Hasomed)

RehaMove 2 sends electrical impulses via electrodes to nerves to evoke muscle contraction. The device meets the provision of the Council Directive 93/42/EEC concerning medical devices.

Locations (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland