Spinal Cord InjuryNCT05265377
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
A study testing Stelo in people with Spinal Cord Injury and Acquired Brain Injury, run by MarsiBionics at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Acquired Brain Injury
- What is being tested?
- Stelo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesSpain
- Study dates
- 21 Sep 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
CEADAC
Madrid
Centre for Automation and Robotics
Madrid
LESCER
Madrid
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injury, Acquired Brain Injury
- Being tested
- Stelo
- Keywords
- exoskeleton, modular, SCI, ABI, gait, spinal cord injury, acquired brain injury
- Medical subject headings
- Spinal Cord Injuries, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteloDevice
Use of Stelo exoskeleton in nine rehabilitation sessions
| Study group | Role | What they receive |
|---|---|---|
| STELO Exoskeleton | Experimental | 3 treatment sessions will be performed with the Stelo exoskeleton. Receives: Device: Stelo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Assessment of heart rate (beats/min)
Measured: Through study completion, an average of 100 days
Oxygen saturation
% O2
Measured: Through study completion, an average of 100 days
Systolic blood pressure
Assesment of systolic blood pressure in mmHg
Measured: Through study completion, an average of 100 days
Diastolic blood pressure
Assesment of diastolic blood pressure in mmHg
Measured: Through study completion, an average of 100 days
Skin integrity
Assess the size (centimetres) of the skin tag produced after use of the exoskeleton.
Measured: Through study completion, an average of 100 days
Pain (Visual Analogic Scale)
Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome. Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome.
Measured: Through study completion, an average of 100 days
Fall prevalence
Number of falling events ocurred from the participant or therapist.
Measured: During the use of the device, for 6 weeks.
Kinematic gait analysis
Assessed by photogrammetry (VICON) in a gait analysis laboratory in healthy subjects
Measured: Once during the first session.
Muscular activation
Assessed by electromyography (NORAXON).
Measured: Once during the first session.
Functional Ambulation Categories
ABI participants
Measured: In all sessions during 6 weeks.
Walking Index for Spinal Cord Injury (WISCI)
SCI participants
Measured: In all sessions during 6 weeks.
Time and assistance with device attachment and removal
Time taken in minutes to fit and remove the participant's device.
Measured: In all sessions during 6 weeks.
Timed Up and Go (TUG)
Distance to go 3 metres, turn around and sit on a chair.
Measured: In all sessions during 6 weeks.
6 Minutes Walking Test (6MWT)
Distance covered using the device in 6 minutes
Measured: In all sessions during 6 weeks.
10 Meters Walking Test (10MWT)
Time to cover 10 meters using the decvice.
Measured: In all sessions during 6 weeks.
Device malfunction
Number and type of device malfunction
Measured: In all sessions during 6 weeks.
User perception of the device (QUEST 2.0)
QUEST 2.0 will be assessed by the participant
Measured: At the end of the study, 6th week
Participant's satisfaction of the device (Participant Satisfaction scale).
It will be measured through Participant Satisfaction scale.
Measured: At the end of the study, 6th week
Physiotherapist's satisfaction (Therapist Satisfaction Scale)
It will be assessed using Therapist Satisfaction Scale
Measured: At the end of the study, 6th week
SF-12
Quality of life
Measured: At the end of the study, 6th week
Secondary outcomes (2)
Acceptability
Analysis of the drop-out rate during the study period.
Measured: At the end of the study, 6th week
Accesssibility
Number of registered participants in relation to the data of potential participants who were not recruited obtained in the first screening
Measured: At the end of the study, 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start21 Sep 2022
- Primary completion31 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro de Referencia Estatal de Atención Al Daño Cerebral, National Research Council, Spain, Centro Lescer
- Responsible party
- Sponsor
- Investigators
- Elena García Armada, Dr., Principal investigator, National Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265377
- Sponsor's protocol ID
- STELO-US_DCA+LM
- Status last verified
- May 2023
- First submitted
- 11 Jan 2022
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05265377
- Acronym / sponsor ID
- STELO-US_DCA+LM
- Conditions
- Spinal Cord Injury, Acquired Brain Injury
- Keywords
- exoskeleton, modular, SCI, ABI, gait, spinal cord injury, acquired brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Collaborators
- Centro de Referencia Estatal de Atención Al Daño Cerebral, National Research Council, Spain, Centro Lescer
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STELO Exoskeleton | Experimental | Device: Stelo3 treatment sessions will be performed with the Stelo exoskeleton. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SteloUse of Stelo exoskeleton in nine rehabilitation sessions | Device | STELO Exoskeleton |
Primary outcome
Heart rate
Time frame: Through study completion, an average of 100 days
Assessment of heart rate (beats/min)
Oxygen saturation
Time frame: Through study completion, an average of 100 days
% O2
Systolic blood pressure
Time frame: Through study completion, an average of 100 days
Assesment of systolic blood pressure in mmHg
Diastolic blood pressure
Time frame: Through study completion, an average of 100 days
Assesment of diastolic blood pressure in mmHg
Skin integrity
Time frame: Through study completion, an average of 100 days
Assess the size (centimetres) of the skin tag produced after use of the exoskeleton.
Pain (Visual Analogic Scale)
Time frame: Through study completion, an average of 100 days
Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome. Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome.
Fall prevalence
Time frame: During the use of the device, for 6 weeks.
Number of falling events ocurred from the participant or therapist.
Kinematic gait analysis
Time frame: Once during the first session.
Assessed by photogrammetry (VICON) in a gait analysis laboratory in healthy subjects
Muscular activation
Time frame: Once during the first session.
Assessed by electromyography (NORAXON).
Functional Ambulation Categories
Time frame: In all sessions during 6 weeks.
ABI participants
Walking Index for Spinal Cord Injury (WISCI)
Time frame: In all sessions during 6 weeks.
SCI participants
Time and assistance with device attachment and removal
Time frame: In all sessions during 6 weeks.
Time taken in minutes to fit and remove the participant's device.
Timed Up and Go (TUG)
Time frame: In all sessions during 6 weeks.
Distance to go 3 metres, turn around and sit on a chair.
6 Minutes Walking Test (6MWT)
Time frame: In all sessions during 6 weeks.
Distance covered using the device in 6 minutes
10 Meters Walking Test (10MWT)
Time frame: In all sessions during 6 weeks.
Time to cover 10 meters using the decvice.
Device malfunction
Time frame: In all sessions during 6 weeks.
Number and type of device malfunction
User perception of the device (QUEST 2.0)
Time frame: At the end of the study, 6th week
QUEST 2.0 will be assessed by the participant
Participant's satisfaction of the device (Participant Satisfaction scale).
Time frame: At the end of the study, 6th week
It will be measured through Participant Satisfaction scale.
Physiotherapist's satisfaction (Therapist Satisfaction Scale)
Time frame: At the end of the study, 6th week
It will be assessed using Therapist Satisfaction Scale
SF-12
Time frame: At the end of the study, 6th week
Quality of life
2 secondary outcomes
Acceptability
Time frame: At the end of the study, 6th week
Accesssibility
Time frame: At the end of the study, 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena García Armada, Dr. principal investigator
National Research Council
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stelo in people with Spinal Cord Injury and Acquired Brain Injury, run by MarsiBionics at 3 sites in Spain.
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 11 inclusion and 7 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: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart rate (time frame: Through study completion, an average of 100 days). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.