Using a powered exoskeleton with electrical stimulation to help patients with spinal cord injuries walk better

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of combining a powered exoskeleton with functional electrical stimulation (FES) for patients with chronic spinal cord injuries (SCI). The study aims to evaluate whether this combined approach can enhance walking function and address secondary health issues associated with SCI. Participants will engage in overground gait training using the Ekso exoskeleton while receiving FES to stimulate muscle activity. The trial seeks to fill a gap in existing research by providing a well-designed randomized clinical trial to assess the benefits of this innovative therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)
* acute deep vein thrombosis
* pregnancy (tested in women of childbearing age (15 - 49 years))

Where it's running

• Swiss Paraplegic Centre
  Nottwil, Canton of Lucerne, Switzerland Recruiting

Study contacts

• Principal investigator: Mario Widmer, PhD — Swiss Paraplegic Research, Nottwil
• Study coordinator: Mario Widmer, PhD
• Email: mario.widmer@paraplegie.ch
• Phone: +41 41 939 51 97

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.