Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT04965727
Eligibility Criteria:
Inclusion Criteria:
* SCI graded as American Spinal Injury Association Impairment Scale (AIS) C or D (able to walk independently for a few meters with a walker)
* Focal spinal cord disorder caused by trauma
* Minimum 12 months post-injury
* Stable medical, physical and psychological condition as considered by Investigators
* Able to understand and interact with the study team in French or English
* Adequate care-giver support and access to appropriate medical care in patient's home community
* Must agree to comply in good faith with all conditions of the study and to attend all required study training and visit
* Must provide and sign Informed Consent prior to any study related procedures
Exclusion Criteria:
* Limitation of walking function based on accompanying (CNS) disorders (i.e., systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
* History of significant autonomic dysreflexia
* Cognitive/brain damage
* Epilepsy
* Use of an intrathecal baclofen pump
* Any active implanted cardiac device such as pacemaker or defibrillator
* Any indication that would require diathermy
* Increased risk for defibrillation
* Severe joint contractures disabling or restricting lower limb movements
* Hematological disorders with increased risk for surgical interventions
* Congenital or acquired lower limb abnormalities (affection of joints and bone)
* Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breastfeeding
* Lack of safe contraception for women of childbearing capacity
* Spinal cord lesion due to either a neurodegenerative disease or a tumor
* Gastrointestinal ulcers in the last five years
* Known or suspected eye disorders or diseases
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
* Any other anatomic or co-morbid conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Participation in another locomotor training study
* Refusal to be informed of any finding during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04965727
Study Brief:
Protocol Section:
NCT04965727