Main Idea:
Analysis of the evolution of quality of life (QoL) of patients with spinal cord injury (SCI) throughout the
clinical trial STImulation of Movement Overground (STIMO) with spinal epidural electrical stimulation (EES)
in combination with Robot-assisted neurorehabilitation. ClinicalTrials.gov Identifier: NCT02936453.
Introduction:
As already cited in the STIMO protocol, SCI patients usually have a diminished QoL.
This new therapy, by EES in combination with a robot-assisted neurorehabilitation, being tested for the very
first time in humans will enhance the ability to stand and walk which has an impact on these patients’ day to
day living as the increased independence in activities of daily living is a key point in the QoL index. The study
only takes into consideration objective test values obtained in the walking laboratory, and excludes the global,
subjective changes in day to day living. An evaluation pertaining specifically to patients with spinal cord
injury, more precise and detailed than at STIMO study initiation, therefore seems to be a significant addition.
Objective:
To put in place a more detailed and effective system for the evaluation of QoL of STIMO trial patients. To
enable a more in-depth analysis that goes further than the SF-36 questionnaire that is used in the original
protocol.
Method:
A subjective, specific and internationally recognized questionnaire, the WHOQOL-Bref was added to the study
at the following timepoints: pre-rehabilitation, intermediate, post-rehabilitation, 3-months extension, 6-month
extension. Analysis of functional independence with the SCIM III at pre-rehab, intermediate, post-rehab and
both extensions. Analysis of the evolution of HRQoL with the SF-36 at pre-implantations, pre-rehabilitation,
post-rehabilitation and 6-months extension.
Expected results:
Concurring with the expected results of the STIMO trial, we hope to obtain an improvement in the patients’
QoL. We hypothesize that there will be a correlation between the objective values obtained in the walking lab
of functional independence evaluated with the SCIM III questionnaire and of health-related QoL obtained
through the SF-36 questionnaire, and the subjective values in the patients’ everyday environment evaluated
with the WHOQOL-Bref survey.
Added value:
This analysis will add a more thorough and detailed dimension to the evaluation of the QoL, including more
parameters than just the ability to move and walk during the experiment. It will take into consideration the
psychological, social, environmental point of view of the patient. In the end, these values that influence the
patients’ day to day living are significant for the end results of the trial.