Safety and Feasibility of TWIICE Rise - Phase 2

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).

NCT Number	NCT07461259
Lead Sponsor	TWIICE Collaborators: Swiss Paraplegic Research, Nottwil
Conditions	Spinal Cord Injuries, Gait Disorders, Neurologic
Enrollment	15 participants
Start Date	2023-07-25
Primary Completion	2027-07-31 (estimated)
Study Completion	2027-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-10