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

NCT06782113 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2025-01-17

No results posted yet for this study

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

Sponsors & Collaborators

  • MEBSTER

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-28
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06782113 on ClinicalTrials.gov