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

N/AActive Not RecruitingNCT06782113

MEBSTER6 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

6

Conditions

Spinal Cord Injury Exoskeleton Device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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.) Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to the end of observation at 14 weeks

Secondary Outcomes

Health-Related Quality of Life (QoL)

To assess improvements in health-related quality of life (QoL) using the WHOQOL-BREF questionnaire, a standardized questionnaire measuring QoL across four domains: physical, psychological, social relationships, and environment. Scale range: 0-100. Interpretation: Higher scores indicate better quality of life.

Time frame: From enrollment to the end of observation at 14 weeks

User Satisfaction Measured by QUEST 2.0

To assess user satisfaction with the UNILEXA exoskeleton using the QUEST 2.0 questionnaire. This evaluates satisfaction with the device and associated services. QUEST 2.0: A validated user satisfaction questionnaire consisting of 12 items across two subscales: device satisfaction and service satisfaction. Each item is rated on a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied).

Time frame: From enrollment to the end of observation at 14 weeks

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

To evaluate the time required to walk 10 meters at a comfortable speed. Unit of Measure: Seconds. Interpretation: Lower times indicate better functional mobility.

Time frame: From enrollment to the end of observation at 14 weeks

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

To assess mobility performance by measuring the time required to stand up from a chair, walk 3 meters, turn, and return to sit in the chair. Unit of Measure: Seconds. Interpretation: Lower times indicate better functional mobility.

Time frame: From enrollment to the end of observation at 14 weeks

Level of Assistance Required for Mobility

To evaluate the level of physical assistance required during mobility tasks using a 6-point ordinal scale. Scale range: 0-5, where 0 = no assistance and 5 = full physical assistance required. Interpretation: Lower scores indicate better functional independence.

Time frame: From enrollment to the end of observation at 14 weeks

Rating of Perceived Exertion Measured by Borg RPE

To evaluate the perceived exertion of participants during mobility tasks using the Borg RPE scale. Borg RPE Scale: Measures exertion on a scale from 0-10, where 0 = no exertion and 10 = maximal exertion.

Time frame: From enrollment to the end of observation at 14 weeks

Pain Intensity Measured by Visual Analog Scale (VAS)

To assess the pain intensity experienced by participants during mobility tasks using the Visual Analog Scale (VAS). VAS Scale: Measures pain on a scale from 0-10, where 0 = no pain and 10 = the worst imaginable pain.

Time frame: From enrollment to the end of observation at 14 weeks

Cognitive and Physical Workload Measured by NASA-TLX

To evaluate the cognitive and physical workload experienced by participants during mobility tasks using the NASA Task Load Index (NASA-TLX) questionnaire. NASA-TLX: A multidimensional workload assessment tool with six subscales: mental demand, physical demand, temporal demand, performance, effort, and frustration. Scale range: 0-20 for each subscale. Interpretation: Higher scores indicate greater workload in each category.

Time frame: From enrollment to the end of observation at 14 weeks

NCT06782113 - Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking | Crick | Crick