Status:
COMPLETED
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
Lead Sponsor:
MarsiBionics
Collaborating Sponsors:
Centro de Referencia Estatal de Atención Al Daño Cerebral
National Research Council, Spain
Conditions:
Spinal Cord Injury
Acquired Brain Injury
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Gait impairment in people with acquired brain injury (ABI) and spinal cord injury (SCI) can be very heterogeneous. For this reason, STELO has been developed: a new concept of exoskeleton based on modu...
Detailed Description
A test phase will be conducted in healthy volunteers as a proof of concept with the aim of evaluating safety and usability in healthy participants prior to the use of the device in the ABI or SCI popu...
Eligibility Criteria
Inclusion
- Weight \< 100 kg.
- Height 150-190 cm.
- Hip width between 30 - 45 cm.
- Distance from hip joint centre to knee joint centre: 36 cm - 50 cm.
- Distance from the centre of the knee joint to the ground: 43.5 - 59.5 cm.
- Shoe size EU 36-45.
- Patients must be able to follow simple commands.
- Age 18-85 years.
- Diagnosis of ABI or SCI.
- FAC level in participants with ABI \< 4.
- WISCI II level in participants with SCI \< 20.
Exclusion
- Spasticity (MAS) = 4 in lower limbs.
- Skin alterations in the areas of contact with the device.
- Planned surgical intervention during the duration of the study.
- Two or more osteoporotic fractures in the lower limbs in the last 2 years.
- Presence of other pathologies causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease).
- Surgical operation in the 3 months prior to the start of the study on the limbs and/or spine.
- Psychiatric disorders that interfere with proper use of the device or participation in the study such as impulsivity or inability to understand simple commands.
Key Trial Info
Start Date :
September 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05265377
Start Date
September 21 2022
End Date
April 30 2023
Last Update
May 22 2023
Active Locations (3)
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1
CEADAC
Madrid, Spain
2
Centre for Automation and Robotics
Madrid, Spain
3
LESCER
Madrid, Spain