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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02065830
Recruitment Status : Terminated
First Posted : February 19, 2014
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
IRCCS San Raffaele Roma

Tracking Information
First Submitted Date  ICMJE February 12, 2014
First Posted Date  ICMJE February 19, 2014
Last Update Posted Date September 14, 2022
Study Start Date  ICMJE March 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2014)		 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • 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.
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Outdoor and Indoor Mobility in People With Spinal Cord Injury (ROBOtics Spinal Cord Injury EKSO).
Official Title  ICMJE ROBOticsSpinalCordInjuryEKSO: Outdoor and Indoor Mobility in People With SCI.
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE 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.
Study Arms  ICMJE 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.

Intervention: Device: EKSO
Publications * Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 14, 2014)		 30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02065830
Other Study ID Numbers  ICMJE ROBOSCIEKSO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party IRCCS San Raffaele Roma
Original Responsible Party Patrizio Sale , MD, IRCCS San Raffaele, MD
Current Study Sponsor  ICMJE IRCCS San Raffaele Roma
Original Study Sponsor  ICMJE IRCCS San Raffaele
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrizio Sale, MD IRCCS San Raffaele Pisana Roma
PRS Account IRCCS San Raffaele Roma
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP