Early and intensive motor training (versus usual care) to enhance neurological recovery and function in people with spinal cord injury (SCI)

niversity of Sydney0 sites220 target enrollmentFebruary 1, 2021

Overview

No summary available.

Registry

who.int

Start Date

February 1, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•People will be eligible to participate if they:
•1\.have sustained a traumatic or non\-traumatic SCI of any neurological level in the preceding 10 weeks.
•2\.have an AIS A lesion with motor function (in a key or non\-key muscle) more than three levels below the motor level (on one or both sides), or an AIS C or AIS D lesion (as defined by the International Standards for the Neurological Classification of SCI).
•3\.are male or female, over the age of 16 years at the time of signing informed consent (additional consent from a parent or guardian will be attained for those aged under 18 years).
•4\.have been cleared by the medical team to commence rehabilitation (as documented in the participant’s medical files).
•5\.are likely to remain an inpatient for the next 10 weeks.
•6\.understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
•7\.are willing and able to adhere to the study visit schedule and other protocol requirements.

•People will be excluded if they:
•1\.have any significant medical or physical condition (including pregnancy) or psychiatric illness that could prevent the person from participating in the trial, or would place the person at an unacceptable risk if he/she were to participate.
•2\.are unable to provide informed consent.
•3\.are family members of the research staff.
•4\.are participating in another clinical trial that involves motor training of the key muscles (as defined by the International Standards for Neurological Classification of SCI).
•5\.are unable to speak the official language of the country of recruitment to provide consent.