Back to resultsSafety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
Primary Purpose
Spinal Cord Injury, Acquired Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Stelo
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring exoskeleton, modular, SCI, ABI, gait, spinal cord injury, acquired brain injury
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.
Sites / Locations
- CEADAC
- Centre for Automation and Robotics
- LESCER
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STELO Exoskeleton
Arm Description
3 treatment sessions will be performed with the Stelo exoskeleton.
Outcomes
Primary Outcome Measures
Heart rate
Assessment of heart rate (beats/min)
Oxygen saturation
% O2
Systolic blood pressure
Assesment of systolic blood pressure in mmHg
Diastolic blood pressure
Assesment of diastolic blood pressure in mmHg
Skin integrity
Assess the size (centimetres) of the skin tag produced after use of the exoskeleton.
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.
Fall prevalence
Number of falling events ocurred from the participant or therapist.
Kinematic gait analysis
Assessed by photogrammetry (VICON) in a gait analysis laboratory in healthy subjects
Muscular activation
Assessed by electromyography (NORAXON).
Functional Ambulation Categories
ABI participants
Walking Index for Spinal Cord Injury (WISCI)
SCI participants
Time and assistance with device attachment and removal
Time taken in minutes to fit and remove the participant's device.
Timed Up and Go (TUG)
Distance to go 3 metres, turn around and sit on a chair.
6 Minutes Walking Test (6MWT)
Distance covered using the device in 6 minutes
10 Meters Walking Test (10MWT)
Time to cover 10 meters using the decvice.
Device malfunction
Number and type of device malfunction
User perception of the device (QUEST 2.0)
QUEST 2.0 will be assessed by the participant
Participant's satisfaction of the device (Participant Satisfaction scale).
It will be measured through Participant Satisfaction scale.
Physiotherapist's satisfaction (Therapist Satisfaction Scale)
It will be assessed using Therapist Satisfaction Scale
SF-12
Quality of life
Secondary Outcome Measures
Acceptability
Analysis of the drop-out rate during the study period.
Accesssibility
Number of registered participants in relation to the data of potential participants who were not recruited obtained in the first screening
Full Information
NCT ID
NCT05265377
First Posted
January 11, 2022
Last Updated
May 19, 2023
Sponsor
MarsiBionics
Collaborators
Centro de Referencia Estatal de Atención Al Daño Cerebral, National Research Council, Spain, Centro Lescer
1. Study Identification
Unique Protocol Identification Number
NCT05265377
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MarsiBionics
Collaborators
Centro de Referencia Estatal de Atención Al Daño Cerebral, National Research Council, Spain, Centro Lescer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Acquired Brain Injury
Keywords
exoskeleton, modular, SCI, ABI, gait, spinal cord injury, acquired brain injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STELO Exoskeleton
Arm Type
Experimental
Arm Description
3 treatment sessions will be performed with the Stelo exoskeleton.
Intervention Type
Device
Intervention Name(s)
Stelo
Intervention Description
Use of Stelo exoskeleton in nine rehabilitation sessions
Primary Outcome Measure Information:
Title
Heart rate
Description
Assessment of heart rate (beats/min)
Time Frame
Through study completion, an average of 100 days
Title
Oxygen saturation
Description
% O2
Time Frame
Through study completion, an average of 100 days
Title
Systolic blood pressure
Description
Assesment of systolic blood pressure in mmHg
Time Frame
Through study completion, an average of 100 days
Title
Diastolic blood pressure
Description
Assesment of diastolic blood pressure in mmHg
Time Frame
Through study completion, an average of 100 days
Title
Skin integrity
Description
Assess the size (centimetres) of the skin tag produced after use of the exoskeleton.
Time Frame
Through study completion, an average of 100 days
Title
Pain (Visual Analogic Scale)
Description
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.
Time Frame
Through study completion, an average of 100 days
Title
Fall prevalence
Description
Number of falling events ocurred from the participant or therapist.
Time Frame
During the use of the device, for 6 weeks.
Title
Kinematic gait analysis
Description
Assessed by photogrammetry (VICON) in a gait analysis laboratory in healthy subjects
Time Frame
Once during the first session.
Title
Muscular activation
Description
Assessed by electromyography (NORAXON).
Time Frame
Once during the first session.
Title
Functional Ambulation Categories
Description
ABI participants
Time Frame
In all sessions during 6 weeks.
Title
Walking Index for Spinal Cord Injury (WISCI)
Description
SCI participants
Time Frame
In all sessions during 6 weeks.
Title
Time and assistance with device attachment and removal
Description
Time taken in minutes to fit and remove the participant's device.
Time Frame
In all sessions during 6 weeks.
Title
Timed Up and Go (TUG)
Description
Distance to go 3 metres, turn around and sit on a chair.
Time Frame
In all sessions during 6 weeks.
Title
6 Minutes Walking Test (6MWT)
Description
Distance covered using the device in 6 minutes
Time Frame
In all sessions during 6 weeks.
Title
10 Meters Walking Test (10MWT)
Description
Time to cover 10 meters using the decvice.
Time Frame
In all sessions during 6 weeks.
Title
Device malfunction
Description
Number and type of device malfunction
Time Frame
In all sessions during 6 weeks.
Title
User perception of the device (QUEST 2.0)
Description
QUEST 2.0 will be assessed by the participant
Time Frame
At the end of the study, 6th week
Title
Participant's satisfaction of the device (Participant Satisfaction scale).
Description
It will be measured through Participant Satisfaction scale.
Time Frame
At the end of the study, 6th week
Title
Physiotherapist's satisfaction (Therapist Satisfaction Scale)
Description
It will be assessed using Therapist Satisfaction Scale
Time Frame
At the end of the study, 6th week
Title
SF-12
Description
Quality of life
Time Frame
At the end of the study, 6th week
Secondary Outcome Measure Information:
Title
Acceptability
Description
Analysis of the drop-out rate during the study period.
Time Frame
At the end of the study, 6th week
Title
Accesssibility
Description
Number of registered participants in relation to the data of potential participants who were not recruited obtained in the first screening
Time Frame
At the end of the study, 6th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena García Armada, Dr.
Organizational Affiliation
National Research Council
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEADAC
City
Madrid
Country
Spain
Facility Name
Centre for Automation and Robotics
City
Madrid
Country
Spain
Facility Name
LESCER
City
Madrid
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
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