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

Study Overview
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Brief Summary
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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
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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.

Official Title
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ROBOticsSpinalCordInjuryEKSO: Outdoor and Indoor Mobility in People With SCI.

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: EKSO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot Safety and Efficacy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months. | 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. | 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. | 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. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robot, Spinal Cord Injury, Gait, Quality of life, Rehabilitation, Lower Limb