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Spinal Cord InjuryNCT06782113

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

An observational study of Spinal Cord Injury and Exoskeleton Device, run by MEBSTER at 1 site in Czechia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injury, Exoskeleton Device
How many people
6 participants
Where
1 siteCzechia
Study dates
28 Nov 2024to Mar 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals with lower limb paralysis who have purchased and are actively using the UNILEXA exoskeleton.

Who may be able to join

  • 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.)

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Státní léčebné lázně Janské Lázně, státní podnik

    Janske Lazne, 542 25

Other trials in Czechia

About this study

Official title: Prospective Study on the Safety and Efficacy of the UNILEXA Exoskeleton for Regular Verticalization and Assisted Walking

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.

Medical subject headings
Spinal Cord Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of observation at 14 weeks

Secondary outcomes (8)

  1. 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.

    Measured: From enrollment to the end of observation at 14 weeks

  2. 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).

    Measured: From enrollment to the end of observation at 14 weeks

  3. 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.

    Measured: From enrollment to the end of observation at 14 weeks

  4. 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.

    Measured: From enrollment to the end of observation at 14 weeks

  5. 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.

    Measured: From enrollment to the end of observation at 14 weeks

  6. 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.

    Measured: From enrollment to the end of observation at 14 weeks

  7. 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.

    Measured: From enrollment to the end of observation at 14 weeks

  8. 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.

    Measured: From enrollment to the end of observation at 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start28 Nov 2024
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06782113
Sponsor's protocol ID
202411 J01
Status last verified
Dec 2024
First submitted
12 Dec 2024
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injury and Exoskeleton Device, run by MEBSTER at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events and Adverse Device Effects [Safety Assessment] (time frame: From enrollment to the end of observation at 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06782113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.

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