Safety and Feasibility of TWIICE Rise - Phase 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTWIICE
About this trial
The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury.
This study is done in two phases:
The first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with 5 patients over 6 sessions in clinic. The second phase is being conducted with TWIICE Rise 1.0. This version has potentially improved functionalities based on feedback from Phase 1. Safety and feasibility will be assessed with 10 patients over 10 sessions in different settings (clinic, home, and community environment).
Eligibility criteria
Qualifiers
Informed Consent signed by the subject.
Traumatic and non-traumatic SCI
Motor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or Motor Complete SCI with NLI T1-L5 as determined by the ISNCSCI.
Male and non-pregnant, non-lactating female aged 18 to 70 years old
Disqualifiers
History of severe neurological injuries other than spinal cord injury (e.g., Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
Ability to walk 10 meters without physical assistance of a person
Severe concurrent medical disease, illness, or condition
Systemic or peripheral infection influencing wearing an exoskeleton.
Trial design
Treatments tested in this trial
- TWIICE Rise
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
TWIICE
Lead sponsor
Swiss Paraplegic Research, Nottwil
Collaborator
Source ClinicalTrials.gov