Safety Study of Outdoor and Indoor Mobility in People With Spinal Cord Injury (ROBOtics Spinal Cord Injury EKSO). (ROBOSCIEKSO)

September 9, 2022 updated by: IRCCS San Raffaele Roma

ROBOticsSpinalCordInjuryEKSO: Outdoor and Indoor Mobility in People With SCI.

The aim of this study will be to evaluate the safety and the efficacy of a new robotic exoskeleton device in subjects with Spinal Cord Injury (SCI) and in subjects with other neurological disease with an impairment of lower limbs.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this study, 30 participants with chronic spinal cord injury will undergo a 8-week training schedule for ambulation with the EKSO™ device.

Ekso™ is a wearable bionic suit which enables individuals with any amount of lower extremity weakness to stand up and walk over ground with a natural, full weight bearing, reciprocal gait. Walking is achieved by the user's weight shifts to activate sensors in the device which initiate steps. Battery-powered motors drive the legs, replacing deficient neuromuscular function.

Ekso provides functional based rehabilitation, over ground gait training, and upright, weight bearing exercise unlike any other. It has been designed for the needs of busy therapists treating a wide range of patients in a single day. The suit is strapped over the users´ clothing with easy adjustments to transition between patients in as little as five minutes.

Before, during and after training sessions the subjects will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00161
        • IRCCS San Raffaele Pisana Roma
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy
        • Fondazione Centri di Riabilitazione Padre Pio Onlus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic motor complete or incomplete cervical and thoracic (C7-T12) spinal cord injury.
  • Skin integrity.
  • Adequate hip, knee and ankle range of motion.
  • Spasticity level of 3 or less (Ashworth scale).

Exclusion Criteria:

  • Cardiological or respiratory comorbidity.
  • Hemodynamic instability.
  • Presence of unhealed fractures.
  • Presence of heterotopic ossification that may impede walking.
  • Presence of osteoporosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot Safety and Efficacy

The subjects will undergo inpatient rehabilitation consisting of a treatment cycle of 30/40 training section using the robot EKSO system device, according to individually tailored exercise scheduling.

The practice will include robot-assisted walking at variable speeds for 45/60 min and balance training.
Device: EKSO

The subjects will undergo inpatient rehabilitation consisting of a treatment cycle of 30/40 training section using the robot EKSO system device, according to individually tailored exercise scheduling.

The practice will include robot-assisted walking at variable speeds for 45/60 min and balance training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months.
Time Frame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Change in score between 0 and 24 weeks. 3D Gait Analysis will be collected at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).
Ekso training at 0 and 8 weeks, and 24-week follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Satisfaction Questionnaire.
Time Frame: Ekso training at 0 and 8 weeks, and 24-week follow-up
Change in score between 0 and 24 weeks. The 10 questions will be asked for each subject during and upon the completion of the active participation phase of the treatment.
Ekso training at 0 and 8 weeks, and 24-week follow-up
Change in blood pressure and heart rate during the training.
Time Frame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Blood pressure and heart rate will be monitorized every day during the training and the data will be collected at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).
Ekso training at 0 and 8 weeks, and 24-week follow-up.
6 minutes walking test.
Time Frame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Change in score between 0 and 24 weeks. The 6 minutes walking test will be collected in indoor and outdoor condition at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).
Ekso training at 0 and 8 weeks, and 24-week follow-up.
Timed Up and Go test.
Time Frame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Change in score between 0 and 24 weeks. Timed Up and Go test will be collected in indoor and outdoor condition at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).
Ekso training at 0 and 8 weeks, and 24-week follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Investigators

  • Principal Investigator: Patrizio Sale, MD, IRCCS San Raffaele Pisana Roma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROBOSCIEKSO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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