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

Spinal Cord Injury Clinical Trial

— ROBOSCIEKSO  

Official title:

ROBOticsSpinalCordInjuryEKSO: Outdoor and Indoor Mobility in People With SCI.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02065830
• Other study ID #: ROBOSCIEKSO
• Status: Terminated
• Phase: N/A
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2022
• Source: IRCCS San Raffaele Roma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Pisana Roma	Roma
Italy	Fondazione Centri di Riabilitazione Padre Pio Onlus	San Giovanni Rotondo	Foggia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.