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

NCT05187650 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries
  • Gait Disorders, Neurologic

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.

Sponsors & Collaborators

  • Mario Widmer

    lead NETWORK

Principal Investigators

  • Mario Widmer, PhD · Swiss Paraplegic Research, Nottwil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05187650 on ClinicalTrials.gov