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

NCT ID: NCT05265377

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2023-04-30

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.

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.

Conditions

Spinal Cord Injury; Acquired Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STELO Exoskeleton

3 treatment sessions will be performed with the Stelo exoskeleton.

Group Type: EXPERIMENTAL

Stelo

Intervention Type: DEVICE

Use of Stelo exoskeleton in nine rehabilitation sessions

Interventions

Stelo

Use of Stelo exoskeleton in nine rehabilitation sessions

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Referencia Estatal de Atención Al Daño Cerebral

OTHER

Sponsor Role: collaborator

National Research Council, Spain

OTHER_GOV

Sponsor Role: collaborator

Centro Lescer

UNKNOWN

Sponsor Role: collaborator

MarsiBionics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena García Armada, Dr.

Role: PRINCIPAL_INVESTIGATOR

National Research Council

Locations

CEADAC

Madrid, , Spain

Centre for Automation and Robotics

Madrid, , Spain

LESCER

Madrid, , Spain

Countries

Spain

Other Identifiers

STELO-US_DCA+LM

Identifier Type: -

Identifier Source: org_study_id