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

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.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury; Spinal Cord Injury
• Intervention / Treatment: Device: Stelo

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • CEADAC
  • Madrid, Spain
    • Centre for Automation and Robotics
  • Madrid, Spain
    • LESCER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STELO Exoskeleton; 3 treatment sessions will be performed with the Stelo exoskeleton.	Device: Stelo; Use of Stelo exoskeleton in nine rehabilitation sessions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MarsiBionics
• Collaborators: National Research Council, Spain; Centro de Referencia Estatal de Atención Al Daño Cerebral; Centro Lescer
• Investigators: Principal Investigator: Elena García Armada, Dr., National Research Council

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: gait; spinal cord injury; SCI; modular; ABI; exoskeleton; acquired brain injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Brain Injuries; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: STELO-US_DCA+LM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No