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NCT Number: NCT05265377

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEADAC, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stelo

Device

Use of Stelo exoskeleton in nine rehabilitation sessions

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

MarsiBionics

Industry

Collaborators

  • Centro Lescer
  • Centro de Referencia Estatal de Atención Al Daño Cerebral
  • National Research Council, Spain

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2022
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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