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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265377
• Other study ID #: STELO-US_DCA+LM
• Status: Completed
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: MarsiBionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• Stelo
Use of Stelo exoskeleton in nine rehabilitation sessions

Locations

Country	Name	City	State
Spain	CEADAC	Madrid
Spain	Centre for Automation and Robotics	Madrid
Spain	LESCER	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
MarsiBionics	Centro de Referencia Estatal de Atención Al Daño Cerebral, Centro Lescer, National Research Council, Spain

Country where clinical trial is conducted

Spain, 

Outcome

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