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

NCT ID: NCT06782113

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-28

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury Exoskeleton Device

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MEBSTER

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Státní léčebné lázně Janské Lázně, státní podnik

Janske Lazne, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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202411 J01

Identifier Type: -

Identifier Source: org_study_id

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