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ACTIVE NOT RECRUITING
NCT06782113

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

Sponsor: MEBSTER

View on ClinicalTrials.gov

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

Locations (1)

Státní léčebné lázně Janské Lázně, státní podnik

Janske Lazne, Czechia