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

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Unknown status

CT.gov ID

NCT02065830

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Mar 1, 2016

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months. [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

Participant Satisfaction Questionnaire. [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. [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. [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. [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

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).