Clinical trial NCT02065830: Safety Study of Outdoor and Indoor Mobility in People With Spinal Cord Injury (ROBOtics Spinal Cord Injury EKSO).
Official title: ROBOticsSpinalCordInjuryEKSO: Outdoor and Indoor Mobility in People With SCI.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Robot
Spinal Cord Injury
Gait
Quality of life
Rehabilitation
Lower Limb
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months.
timeFrame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Secondary outcomes:
measure: Participant Satisfaction Questionnaire.
timeFrame: Ekso training at 0 and 8 weeks, and 24-week follow-up
measure: Change in blood pressure and heart rate during the training.
timeFrame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
measure: 6 minutes walking test.
timeFrame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
measure: Timed Up and Go test.
timeFrame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
Other outcomes:
Locations:
city: San Giovanni Rotondo
country: Italy
facility: Fondazione Centri di Riabilitazione Padre Pio Onlus
state: Foggia
city: Roma
country: Italy
facility: IRCCS San Raffaele Pisana Roma
Study officials:
affiliation: IRCCS San Raffaele Pisana Roma
name: Patrizio Sale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.