Determining the effect on functional ability and quality of life of a lower limb robotic exoskeleton in patients with Spinal cord InjuRy (SIR HELLEN).

niversity of Newcastle0 sites7 target enrollmentApril 20, 2018

Overview

No summary available.

Registry

who.int

Start Date

April 20, 2018

End Date

March 11, 2020

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Newcastle

•1\.Diagnosis of traumatic or non\-traumatic SCI at least 3 months prior to enrolment
•2\.Resident of the Hunter region
•3\.18 years of age or older
•4\.Discharged from inpatient rehabilitation programs
•5\.Severe mobility impairment and reliant on wheelchair, mobility aid, or the assistance of others for standing activities ( scores \< /\=5 on the mobility assessment of SCIM\-III)

•1\.Weight between 40 kg and 100kg; height between 4’8” and 6'4 (as per the recommendations of the robotic manufacturer)
•2\.Pregnancy
•3\.Unstable or severe cardiac or respiratory compromise
•4\.Nonconsolidated fractures in lower limbs/pelvis/spine or diagnosed severe osteopenia ( t\-score less than or equal to \-2\.5\)
•5\.Significant cognitive impairment (Montreal Cognitive Assessment Score of less than 19\)
•6\.Any medical condition which limits the ability to exercise in an upright position. This includes: pressure sores in contact with the exoskeleton, lower limb heterotrophic ossification, severe lower limb muscle contracture, spinal instability, acute deep vein thrombosis, recurrent attacks of autonomic dysreflexia requiring medical intervention, hip subluxation, a history of pathological fractures in the lower limbs in the last 2 years)