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

• ClinicalTrials.gov Identifier: NCT05265377
• Recruitment Status: Completed
• First Posted: March 3, 2022
• Last Update Posted: May 22, 2023
• Sponsor: MarsiBionics
• Collaborators: Centro de Referencia Estatal de Atención Al Daño Cerebral; National Research Council, Spain; Centro Lescer
• Information provided by (Responsible Party): MarsiBionics

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury; Acquired Brain Injury	Device: Stelo	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
• Actual Study Start Date: September 21, 2022
• Actual Primary Completion Date: March 31, 2023
• Actual Study Completion Date: April 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Heart rate [ Time Frame: Through study completion, an average of 100 days ]
   Assessment of heart rate (beats/min)
2. Oxygen saturation [ Time Frame: Through study completion, an average of 100 days ]
   % O2
3. Systolic blood pressure [ Time Frame: Through study completion, an average of 100 days ]
   Assesment of systolic blood pressure in mmHg
4. Diastolic blood pressure [ Time Frame: Through study completion, an average of 100 days ]
   Assesment of diastolic blood pressure in mmHg
5. 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.
6. 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.
7. Fall prevalence [ Time Frame: During the use of the device, for 6 weeks. ]
   Number of falling events ocurred from the participant or therapist.
8. Kinematic gait analysis [ Time Frame: Once during the first session. ]
   Assessed by photogrammetry (VICON) in a gait analysis laboratory in healthy subjects
9. Muscular activation [ Time Frame: Once during the first session. ]
   Assessed by electromyography (NORAXON).
10. Functional Ambulation Categories [ Time Frame: In all sessions during 6 weeks. ]
    ABI participants
11. Walking Index for Spinal Cord Injury (WISCI) [ Time Frame: In all sessions during 6 weeks. ]
    SCI participants
12. 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.
13. 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.
14. 6 Minutes Walking Test (6MWT) [ Time Frame: In all sessions during 6 weeks. ]
    Distance covered using the device in 6 minutes
15. 10 Meters Walking Test (10MWT) [ Time Frame: In all sessions during 6 weeks. ]
    Time to cover 10 meters using the decvice.
16. Device malfunction [ Time Frame: In all sessions during 6 weeks. ]
    Number and type of device malfunction
17. 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
18. 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.
19. Physiotherapist's satisfaction (Therapist Satisfaction Scale) [ Time Frame: At the end of the study, 6th week ]
    It will be assessed using Therapist Satisfaction Scale
20. SF-12 [ Time Frame: At the end of the study, 6th week ]
    Quality of life

Secondary Outcome Measures :

1. Acceptability [ Time Frame: At the end of the study, 6th week ]
   Analysis of the drop-out rate during the study period.
2. Accesssibility [ Time Frame: At the end of the study, 6th week ]
   Number of registered participants in relation to the data of potential participants who were not recruited obtained in the first screening

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Spain

CEADAC

Madrid, Spain

Centre for Automation and Robotics

Madrid, Spain

LESCER

Madrid, Spain

Sponsors and Collaborators

MarsiBionics

Centro de Referencia Estatal de Atención Al Daño Cerebral

National Research Council, Spain

Centro Lescer

Investigators

• Principal Investigator: Elena García Armada, Dr.; National Research Council

More Information

• Responsible Party: MarsiBionics
• ClinicalTrials.gov Identifier: NCT05265377
• Other Study ID Numbers: STELO-US_DCA+LM
• First Posted: March 3, 2022
• Last Update Posted: May 22, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MarsiBionics:

exoskeleton; modular; SCI; ABI; gait; spinal cord injury; acquired brain injury

Additional relevant MeSH terms:

Brain Injuries; Spinal Cord Injuries; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases