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

Marsi Bionics

Status

Completed

Conditions

Acquired Brain Injury

Spinal Cord Injury

Treatments

Device: Stelo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05265377

STELO-US_DCA+LM

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.