Status:
RECRUITING
Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT
Lead Sponsor:
Mario Widmer
Conditions:
Spinal Cord Injuries
Gait Disorders, Neurologic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ev...
Detailed Description
Paraplegia is a serious event that leads to a complete or partial loss of motor, sensory and vegetative functions. Regaining of gait, balance and mobility are important priorities for persons with a s...
Eligibility Criteria
Inclusion
- 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
- 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))
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05187650
Start Date
March 18 2022
End Date
December 31 2027
Last Update
December 18 2025
Active Locations (1)
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1
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, Switzerland, 6207