Prospective Study on the Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events and Adverse Device Effects [Safety Assessment]
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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]
Time Frame: From enrollment to the end of observation at 14 weeks
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.
Secondary Outcomes
- 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)
- Rating of Perceived Exertion Measured by Borg RPE(From enrollment to the end of observation at 14 weeks)
- Pain Intensity Measured by Visual Analog Scale (VAS)(From enrollment to the end of observation at 14 weeks)
- Cognitive and Physical Workload Measured by NASA-TLX(From enrollment to the end of observation at 14 weeks)