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Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking
Sponsor: MEBSTER
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.
Official title: Prospective Study on the Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
6
Start Date
2024-11-28
Completion Date
2025-03
Last Updated
2025-01-17
Healthy Volunteers
No
Conditions
Locations (1)
Státní léčebné lázně Janské Lázně, státní podnik
Janske Lazne, Czechia