NCT06782113

Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking

Prospective Study on the Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6 (estimated)
• Sponsor: MEBSTER · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this clinical follow-up is to analyze data regarding the safety of the UNILEXA passive exoskeleton post-market. The secondary objective is to assess the effectiveness of the device in improving activities of daily living (ADL) through improved mobility, endurance and health-related quality of life (QoL). The aim of this study is to provide real-world evidence to support wider clinical and home use of the exoskeleton. This observational study is designed for 6 participants from a population of individuals with lower limb paralysis. The study will have a duration of 14 weeks. During this period, participants will visit Janske Lazne three times for routine measurements in a biomechanical laboratory, which will be integrated into their usual physiotherapy sessions.

Conditions

• Spinal Cord Injury
• Exoskeleton Device

Timeline

• Start date: 2024-11-28
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

1 site across 1 country: Czechia