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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.
In this study, 30 participants with chronic spinal cord injury will undergo a 8-week training schedule for ambulation with the EKSOâ„¢ device.
Eksoâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot Safety and Efficacy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EKSO | Device | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrizio Sale, MD | IRCCS San Raffaele Pisana Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Centri di Riabilitazione Padre Pio Onlus | San Giovanni Rotondo | Foggia | Italy | |||
| IRCCS San Raffaele Pisana Roma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26818847 | Derived | 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. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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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. |
| Roma |
| 00161 |
| Italy |
| D014947 | Wounds and Injuries |