Clinical trial NCT05265377: Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
Official title: Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Acquired Brain Injury
Keywords: exoskeleton
modular
SCI
ABI
gait
spinal cord injury
acquired brain injury
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
Collaborators: name: Centro de Referencia Estatal de Atención Al Daño Cerebral
name: National Research Council, Spain
name: Centro Lescer
First posted: 2022-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 modular technology for gait assistance. It allows a personalised configuration according to the functional capacity of each patient, as the therapist can choose which robotic joints to use depending on the therapeutic goal and on the patient recovery phase. The objective is to analyse the usability of the STELO modular exoskeleton in people with ABI and SCI.

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 population (Phase 2).

After verifying that the device is safe in healthy people, phase 2 will begin: it consists of a total of 10 visits. These visits will include gait training sessions using the STELO modular exoskeleton.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Heart rate
timeFrame: Through study completion, an average of 100 days
measure: Oxygen saturation
timeFrame: Through study completion, an average of 100 days
measure: Systolic blood pressure
timeFrame: Through study completion, an average of 100 days
measure: Diastolic blood pressure
timeFrame: Through study completion, an average of 100 days
measure: Skin integrity
timeFrame: Through study completion, an average of 100 days
measure: Pain (Visual Analogic Scale)
timeFrame: Through study completion, an average of 100 days
measure: Fall prevalence
timeFrame: During the use of the device, for 6 weeks.
measure: Kinematic gait analysis
timeFrame: Once during the first session.
measure: Muscular activation
timeFrame: Once during the first session.
measure: Functional Ambulation Categories
timeFrame: In all sessions during 6 weeks.
measure: Walking Index for Spinal Cord Injury (WISCI)
timeFrame: In all sessions during 6 weeks.
measure: Time and assistance with device attachment and removal
timeFrame: In all sessions during 6 weeks.
measure: Timed Up and Go (TUG)
timeFrame: In all sessions during 6 weeks.
measure: 6 Minutes Walking Test (6MWT)
timeFrame: In all sessions during 6 weeks.
measure: 10 Meters Walking Test (10MWT)
timeFrame: In all sessions during 6 weeks.
measure: Device malfunction
timeFrame: In all sessions during 6 weeks.
measure: User perception of the device (QUEST 2.0)
timeFrame: At the end of the study, 6th week
measure: Participant's satisfaction of the device (Participant Satisfaction scale).
timeFrame: At the end of the study, 6th week
measure: Physiotherapist's satisfaction (Therapist Satisfaction Scale)
timeFrame: At the end of the study, 6th week
measure: SF-12
timeFrame: At the end of the study, 6th week
Secondary outcomes:
measure: Acceptability
timeFrame: At the end of the study, 6th week
measure: Accesssibility
timeFrame: At the end of the study, 6th week
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CEADAC
city: Madrid
country: Spain
facility: Centre for Automation and Robotics
city: Madrid
country: Spain
facility: LESCER
Study officials:
affiliation: National Research Council
name: Elena García Armada, Dr.
role: PRINCIPAL_INVESTIGATOR
References: