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

NCT06782113 | Active Not Recruiting

• 1 other identifier: 202411 J01
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events and Adverse Device Effects [Safety Assessment]

  Analyze data regarding the safety of the UNILEXA exoskeleton by determining the incidence of adverse events (AEs) and adverse device effects (ADEs), such as falls, skin injuries, and other injuries, over the study period.

  From enrollment to the end of observation at 14 weeks

Secondary Outcomes (8)

• Health-Related Quality of Life (QoL)

  From enrollment to the end of observation at 14 weeks

• User Satisfaction Measured by QUEST 2.0

  From enrollment to the end of observation at 14 weeks

• Time to Complete the 10-Meter Walk Test (10MWT)

  From enrollment to the end of observation at 14 weeks

• Time to Complete the Timed Up and Go (TUG) Test

  From enrollment to the end of observation at 14 weeks

• Level of Assistance Required for Mobility

  From enrollment to the end of observation at 14 weeks

Other Outcomes (6)

• Amplitude of Vertical and Lateral Acromion Marker Movement

  From enrollment to the end of observation at 14 weeks

• Amplitude of Pelvic Angular Movements (Rotation, Hiking, Tilting)

  From enrollment to the end of observation at 14 weeks

• Number of Steps Taken Per Training Session

  From enrollment to the end of observation at 14 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with lower limb paralysis who have purchased and are actively using the UNILEXA exoskeleton.

You may qualify if:

• Individuals with lower limb paralysis due to spinal cord injury (T5-T12 lesion) in chronic phase (\> 6 months)
• Age 18 years and older.
• ASIA score: AIS A or AIS B.
• Ability to provide informed consent and follow study procedures.
• Weight below 100 kg.
• Height between 165 - 195 cm. (PI can decide to include participants outside of this range. The IFU specifies an EXTENDED range of 160 - 200 cm with certain conditions.)

You may not qualify if:

• Severe contractures in the lower limbs.
• Spasticity greater than 2 according to the Modified Ashworth Scale (MAS).
• Autonomic dysreflexia.
• Spinal instability.
• Untreated deep vein thrombosis.
• Untreated fractures of the pelvis or limbs.
• Advanced osteoporosis.
• Complete tetraplegia.
• Lack of upper limb control grade 3 or less, according to the ASIA test.
• History of fracture due to osteoporosis.
• Medication that increases the chance of fracture.

Sponsors & Collaborators

• MEBSTER: lead

Study Sites (1)

Státní léčebné lázně Janské Lázně, státní podnik

Janske Lazne, 542 25, Czechia

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 17, 2025
• Study Start: November 28, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 17, 2025

Record last verified: 2024-12

Locations

CZ (1)