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

Launched by MARIO WIDMER · Jan 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a powered exoskeleton paired with functional electrical stimulation (FES) for patients with chronic spinal cord injuries (SCI) who have difficulty walking. The goal is to see if combining these two therapies during the same session can improve walking ability more than using either treatment alone. So far, while there is some evidence that powered exoskeletons can help with walking, this is the first well-designed study to directly compare the benefits of this combined approach.

To participate in the trial, individuals must be between 65 and 74 years old, have a chronic and incomplete spinal cord injury (lasting more than a year), and be able to stand and walk a short distance, even with some help. However, there are some restrictions, such as weight and height limits, certain medical conditions, and injuries that could interfere with the therapy. Participants can expect to engage in sessions involving the exoskeleton and FES, potentially improving their walking ability and overall mobility. This trial is currently recruiting, and it's an exciting opportunity for those who qualify to contribute to important research in rehabilitation for spinal cord injuries.

Gender

ALL

Eligibility 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))