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

IRCCS San Raffaele Roma

Status: Terminated

Conditions: Spinal Cord Injury

Treatments: Device: EKSO

Study type: Interventional

Funder types: Other

Identifiers

NCT02065830

ROBOSCIEKSO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Robot Safety and Efficacy

Experimental group

Description:

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.

Treatment:

Device: EKSO