Clinical trial NCT06782113: Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking
Official title: Prospective Study on the Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Cord Injury
Exoskeleton Device
Lead sponsor: MEBSTER
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with lower limb paralysis who have purchased and are actively using the UNILEXA exoskeleton.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events and Adverse Device Effects [Safety Assessment]
timeFrame: From enrollment to the end of observation at 14 weeks
Secondary outcomes:
measure: Health-Related Quality of Life (QoL)
timeFrame: From enrollment to the end of observation at 14 weeks
measure: User Satisfaction Measured by QUEST 2.0
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Time to Complete the 10-Meter Walk Test (10MWT)
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Time to Complete the Timed Up and Go (TUG) Test
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Level of Assistance Required for Mobility
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Rating of Perceived Exertion Measured by Borg RPE
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Pain Intensity Measured by Visual Analog Scale (VAS)
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Cognitive and Physical Workload Measured by NASA-TLX
timeFrame: From enrollment to the end of observation at 14 weeks
Other outcomes:
measure: Amplitude of Vertical and Lateral Acromion Marker Movement
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Amplitude of Pelvic Angular Movements (Rotation, Hiking, Tilting)
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Number of Steps Taken Per Training Session
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Total Distance Walked Per Training Session
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Duration of Use Per Training Session
timeFrame: From enrollment to the end of observation at 14 weeks
measure: Heart Rate During Laboratory Tests
timeFrame: From enrollment to the end of observation at 14 weeks
Locations:
city: Janské Lázně
country: Czech Republic
facility: Státní léčebné lázně Janské Lázně, státní podnik
Study officials:
References: