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

MEBSTER

Status: Active, not recruiting

Conditions: Exoskeleton Device; Spinal Cord Injury

Study type: Observational

Funder types: Industry

Identifiers

NCT06782113

202411 J01

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.