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

MarsiBionics20 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury Acquired Brain Injury

SteloDEVICE

Use of Stelo exoskeleton in nine rehabilitation sessions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

CEADAC

Madrid, Spain

Centre for Automation and Robotics

Madrid, Spain

LESCER

Madrid, Spain

Outcomes

Primary Outcomes

Heart rate

Assessment of heart rate (beats/min)

Time frame: Through study completion, an average of 100 days

Oxygen saturation

% O2

Time frame: Through study completion, an average of 100 days

Systolic blood pressure

Assesment of systolic blood pressure in mmHg

Time frame: Through study completion, an average of 100 days

Diastolic blood pressure

Assesment of diastolic blood pressure in mmHg

Time frame: Through study completion, an average of 100 days

Skin integrity

Assess the size (centimetres) of the skin tag produced after use of the exoskeleton.

Time frame: 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.

Time frame: Through study completion, an average of 100 days

Fall prevalence

Number of falling events ocurred from the participant or therapist.

Time frame: During the use of the device, for 6 weeks.

Kinematic gait analysis

Assessed by photogrammetry (VICON) in a gait analysis laboratory in healthy subjects

Time frame: Once during the first session.

Muscular activation

Assessed by electromyography (NORAXON).

Time frame: Once during the first session.

Functional Ambulation Categories

ABI participants