Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury

Conditions
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Spinal Cord Injury, Acquired Brain Injury

Intervention / Treatment
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* Device: Stelo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STELO Exoskeleton<br>3 treatment sessions will be performed with the Stelo exoskeleton. | Device: Stelo<br>* Use of Stelo exoskeleton in nine rehabilitation sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Assessment of heart rate (beats/min) | Through study completion, an average of 100 days | 
| Oxygen saturation | % O2 | Through study completion, an average of 100 days | 
| Systolic blood pressure | Assesment of systolic blood pressure in mmHg | Through study completion, an average of 100 days | 
| Diastolic blood pressure | Assesment of diastolic blood pressure in mmHg | Through study completion, an average of 100 days | 
| Skin integrity | Assess the size (centimetres) of the skin tag produced after use of the exoskeleton. | 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. | Through study completion, an average of 100 days | 
| Fall prevalence | Number of falling events ocurred from the participant or therapist. | During the use of the device, for 6 weeks. | 
| Kinematic gait analysis | Assessed by photogrammetry (VICON) in a gait analysis laboratory in healthy subjects | Once during the first session. | 
| Muscular activation | Assessed by electromyography (NORAXON). | Once during the first session. | 
| Functional Ambulation Categories | ABI participants | In all sessions during 6 weeks. | 
| Walking Index for Spinal Cord Injury (WISCI) | SCI participants | 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. | In all sessions during 6 weeks. | 
| Timed Up and Go (TUG) | Distance to go 3 metres, turn around and sit on a chair. | In all sessions during 6 weeks. | 
| 6 Minutes Walking Test (6MWT) | Distance covered using the device in 6 minutes | In all sessions during 6 weeks. | 
| 10 Meters Walking Test (10MWT) | Time to cover 10 meters using the decvice. | In all sessions during 6 weeks. | 
| Device malfunction | Number and type of device malfunction | In all sessions during 6 weeks. | 
| User perception of the device (QUEST 2.0) | QUEST 2.0 will be assessed by the participant | 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. | At the end of the study, 6th week | 
| Physiotherapist's satisfaction (Therapist Satisfaction Scale) | It will be assessed using Therapist Satisfaction Scale | At the end of the study, 6th week | 
| SF-12 | Quality of life | At the end of the study, 6th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Analysis of the drop-out rate during the study period. | 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 | At the end of the study, 6th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exoskeleton, modular, SCI, ABI, gait, spinal cord injury, acquired brain injury