Under way, not recruiting
Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking
NCT06782113 · MEBSTER · Updated 17 Jan 2025
- What is being tested
- Not stated
- For
- Spinal Cord Injury; Exoskeleton Device
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 6 people. The full rules are on the registry page.
- Where
- Czechia
- When
- Starts or started 28 Nov 2024, ends March 2025. Registered 17 Jan 2025.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Státní léčebné lázně Janské Lázně, státní podnikJanske Lazne, Czechia