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Tests treatment safety and results for Spinal Cord Injuries
Official title Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT
ClinicalTrials.gov ID: NCT05187650
What this study is testing
- What it's testing
- 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 evidence for beneficial effects of over-ground exoskeleton therapy on walking function post-intervention from a meta-analysis on non-randomized, uncontrolled studies.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Exoskeleton device related contraindications: \> 100 kg body weight; Body height: \ 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
See the full eligibility 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)
- Exoskeleton device related contraindications: \> 100 kg body weight; Body height: \ 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))
The study team makes the final eligibility decision.
Where it's taking place
- Nottwil, Canton of Lucerne, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottwil, Canton of Lucerne, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.