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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02065830
Other study ID # ROBOSCIEKSO
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
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