ROBOticsSpinalCordInjuryEKSO: Outdoor and Indoor Mobility in People With SCI.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Cord Injury
- Sponsor
- IRCCS San Raffaele Roma
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months.
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months.
Time Frame: Ekso training at 0 and 8 weeks, and 24-week follow-up.
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).
Secondary Outcomes
- Participant Satisfaction Questionnaire.(Ekso training at 0 and 8 weeks, and 24-week follow-up)
- Change in blood pressure and heart rate during the training.(Ekso training at 0 and 8 weeks, and 24-week follow-up.)
- 6 minutes walking test.(Ekso training at 0 and 8 weeks, and 24-week follow-up.)
- Timed Up and Go test.(Ekso training at 0 and 8 weeks, and 24-week follow-up.)