NCT05265377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

September 21, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

January 11, 2022

Last Update Submit

May 19, 2023

Conditions

Spinal Cord InjuryAcquired Brain Injury

Keywords

exoskeletonmodularSCIABIgaitspinal cord injuryacquired brain injury

Outcome Measures

Primary Outcomes (20)

  • Heart rate

    Assessment of heart rate (beats/min)

    Through study completion, an average of 100 days

  • Oxygen saturation

    % O2

    Through study completion, an average of 100 days

  • Systolic blood pressure

    Assesment of systolic blood pressure in mmHg

    Through study completion, an average of 100 days

  • Diastolic blood pressure

    Assesment of diastolic blood pressure in mmHg

    Through study completion, an average of 100 days

  • Skin integrity

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

    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.

    Through study completion, an average of 100 days

  • Fall prevalence

    Number of falling events ocurred from the participant or therapist.

    During the use of the device, for 6 weeks.

  • Kinematic gait analysis

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

    Once during the first session.

  • Muscular activation

    Assessed by electromyography (NORAXON).

    Once during the first session.

  • Functional Ambulation Categories

    ABI participants

    In all sessions during 6 weeks.

  • Walking Index for Spinal Cord Injury (WISCI)

    SCI participants

    In all sessions during 6 weeks.

  • Time and assistance with device attachment and removal

    Time taken in minutes to fit and remove the participant's device.

    In all sessions during 6 weeks.

  • Timed Up and Go (TUG)

    Distance to go 3 metres, turn around and sit on a chair.

    In all sessions during 6 weeks.

  • 6 Minutes Walking Test (6MWT)

    Distance covered using the device in 6 minutes

    In all sessions during 6 weeks.

  • 10 Meters Walking Test (10MWT)

    Time to cover 10 meters using the decvice.

    In all sessions during 6 weeks.

  • Device malfunction

    Number and type of device malfunction

    In all sessions during 6 weeks.

  • User perception of the device (QUEST 2.0)

    QUEST 2.0 will be assessed by the participant

    At the end of the study, 6th week

  • Participant's satisfaction of the device (Participant Satisfaction scale).

    It will be measured through Participant Satisfaction scale.

    At the end of the study, 6th week

  • Physiotherapist's satisfaction (Therapist Satisfaction Scale)

    It will be assessed using Therapist Satisfaction Scale

    At the end of the study, 6th week

  • SF-12

    Quality of life

    At the end of the study, 6th week

Secondary Outcomes (2)

  • Acceptability

    At the end of the study, 6th week

  • Accesssibility

    At the end of the study, 6th week

Study Arms (1)

STELO Exoskeleton

EXPERIMENTAL

3 treatment sessions will be performed with the Stelo exoskeleton.

Device: Stelo

Interventions

SteloDEVICE

Use of Stelo exoskeleton in nine rehabilitation sessions

STELO Exoskeleton

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CEADAC

Madrid, Spain

Location

Centre for Automation and Robotics

Madrid, Spain

Location

LESCER

Madrid, Spain

Location

MeSH Terms

Conditions

Spinal Cord InjuriesBrain Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBrain DiseasesCraniocerebral Trauma

Study Officials

  • Elena García Armada, Dr.

    National Research Council

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

March 3, 2022

Study Start

September 21, 2022

Primary Completion

March 31, 2023

Study Completion

April 30, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)