Pilot Study to Assess Safety and Ease of Use of TWIICE Rise Exoskeleton for Walking in Adults with Spinal Cord Injury

What this Trial Is About

Researchers are evaluating the safety and feasibility of two versions of the TWIICE Rise, a robotic exoskeleton designed to help patients with spinal cord injury walk. The study includes two phases the first with TWIICE Rise 0.0 involving 5 patients over 6 clinic sessions, and the second with TWIICE Rise 1.0 involving 10 patients over 10 sessions in various settings including clinic, home, and community. This approach allows assessment of device improvements and real-world use for people with spinal cord injuries. Participants in phase 1 complete a training program with TWIICE Rise 0.0 twice a week for 6 weeks, totaling 6 sessions in a clinical setting. Phase 2 participants train with the updated TWIICE Rise 1.0 two to three times a week for up to 10 weeks, totaling 10 sessions that start in a rehabilitation center to learn walking skills, then continue at home and in the community once sufficient skills are achieved. The exoskeleton supports walking under supervision of trained coaches. During the study, various safety and feasibility measures are closely monitored, including adverse device effects, heart rate, blood pressure, pain, fatigue, skin condition, number of steps, walking speed, and walking surface. Mobility skills and performance on walking tests are assessed throughout, with data collected over the full training period. The study helps determine if the exoskeleton can safely and effectively assist walking for patients with spinal cord injuries over a 10-week intervention.

Safety and Feasibility of TWIICE Rise - Phase 2