Using a powered exoskeleton with electrical stimulation to help patients with spinal cord injuries walk better
Effectiveness of a Powered Exoskeleton Combined With Functional Electric Stimulation for Patients With Chronic Spinal Cord Injury: a Randomized Controlled Trial
NA · Swiss Paraplegic Research, Nottwil · NCT05187650
This study is testing if using a powered exoskeleton along with electrical stimulation can help people with spinal cord injuries walk better and improve their overall health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swiss Paraplegic Research, Nottwil (network) |
| Locations | 1 site (Nottwil, Canton of Lucerne) |
| Trial ID | NCT05187650 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic, incomplete spinal cord injuries who can stand and perform a walking test with or without aids.
Not a fit: Patients with severe spasticity, orthopedic limitations, or contraindications related to the exoskeleton will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with spinal cord injuries.
How similar studies have performed: While there have been numerous non-randomized studies showing positive effects of exoskeleton therapy, this combined approach of exoskeleton and FES is novel and has not been previously tested in a randomized clinical trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nottwil, Canton of Lucerne
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, Gait Disorders, Neurologic, SCI, Functional Electrical Stimulation, Exoskeleton, Robotic device, Robotic overground gait training