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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: EKSO Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ROBOticsSpinalCordInjuryEKSO: Outdoor and Indoor Mobility in People With SCI.
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065830


Locations
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Italy
Fondazione Centri di Riabilitazione Padre Pio Onlus
San Giovanni Rotondo, Foggia, Italy
IRCCS San Raffaele Pisana Roma
Roma, Italy, 00161
Sponsors and Collaborators
IRCCS San Raffaele Roma
Investigators
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Principal Investigator: Patrizio Sale, MD IRCCS San Raffaele Pisana Roma
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: IRCCS San Raffaele Roma
ClinicalTrials.gov Identifier: NCT02065830    
Other Study ID Numbers: ROBOSCIEKSO
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Keywords provided by IRCCS San Raffaele Roma:
Robot
Spinal Cord Injury
Gait
 Quality of life
Rehabilitation
Lower Limb
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System