Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05187650

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

Led by Mario Widmer · Updated on 2025-12-18

34

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of a powered exoskeleton combined with functional electrical stimulation (FES) for people with chronic spinal cord injury (SCI). This trial compares the combined therapy to exoskeleton therapy alone to assess improvements in walking and other health functions. The study addresses the potential benefits of merging over-ground robotic therapy with FES, which individually have shown positive effects on muscle strength, endurance, and mobility after SCI. Participants will be randomly assigned to one of two groups: one will train with the EksoNR powered exoskeleton combined with gait-synchronized FES using the FES RehaMove2 device, and the other will train with the EksoNR exoskeleton alone. Training lasts 8 weeks, with three sessions per week, each session involving 30 minutes of active training. The trial evaluates how combining these therapies affects functional outcomes and secondary health parameters compared to exoskeleton therapy without FES. During the study, participants' walking speed, gait function, endurance, balance, muscle strength, and quality of life will be assessed before training, immediately after the 8-week training, and again three months later. Researchers will also monitor training duration, intensity, volume, and cardio-respiratory function throughout the program. The main outcome measured is the change in preferred walking speed shortly after training, with additional measures collected over time to evaluate lasting effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic, incomplete spinal cord injury (more than 1 year) with AIS grades B-D
  • 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 motoneuron function in specific muscles to allow stimulation with FES
Not Eligible

You will not qualify if you...

  • Body weight over 100 kg
  • Body height less than 155 cm or greater than 190 cm
  • Pelvic width over 46 cm
  • Orthopedic limitations such as acute lower limb fractures
  • Contractures or heterotrophic ossification
  • Spasticity with modified Ashworth Scale greater than 3
  • 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 of childbearing age 15-49 years)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants train using the EksoNR powered exoskeleton, either combined with gait-synchronized functional electrical stimulation (FES) or without FES, to improve gait and secondary health outcomes related to spinal cord injury.

3 visits per week (in-person) for 30 minutes each session, totaling 24 sessions

Follow-up

Duration - 3 months post intervention

Participants undergo assessments to evaluate changes in walking speed, gait function, endurance, balance, strength, and quality of life after completing the training period.

2 visits (in-person) within 3 days post-training and at 3 months post intervention

Trial Site Locations

Total: 1 location

1

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland, 6207

Actively Recruiting

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Research Team

M

Mario Widmer, PhD

I

Ines Bersch, PhD

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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Published Research Related To This Trial

Effectiveness of over-ground robotic locomotor training in improving walking performance, cardiovascular demands, secondary complications and user-satisfaction in individuals with spinal cord injuries: A systematic review.

Claire Shackleton, Robert Evans, Delva Shamley...

https://pubmed.ncbi.nlm.nih.gov/31511902

The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury.

Ann M Spungen, William A Bauman, Kousick Biswas...

https://pubmed.ncbi.nlm.nih.gov/32800962

Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking.

Allan J Kozlowski, Thomas N Bryce, Marcel P Dijkers

https://pubmed.ncbi.nlm.nih.gov/26364280

Safety and tolerance of the ReWalk™ exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study.

Gabi Zeilig, Harold Weingarden, Manuel Zwecker...

https://pubmed.ncbi.nlm.nih.gov/22333043

An Approach for the Cooperative Control of FES With a Powered Exoskeleton During Level Walking for Persons With Paraplegia.

Kevin H Ha, Spencer A Murray, Michael Goldfarb

https://pubmed.ncbi.nlm.nih.gov/25915961