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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT04876794
Eligibility Criteria:
Inclusion Criteria:
* 18 to 70 years of age
* Traumatic and non-traumatic SCI
* Currently receiving treatment as an inpatient or outpatient at one of the investigational sites
* AIS A to AIS D with sufficient arm strength to support body weight on a walking frame
* Ability to give informed consent
Exclusion Criteria:
* WISCI II without exoskeleton of \>16
* 5 or more risk factors for fragility as stated by Craven et al (29)
* History of lower limb fragility fractures in the last 2 years
* Deterioration \> 3 points of the total International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor score within the last 4 weeks
* Spinal instability
* Modified Ashworth scale (MAS) \> 3 in lower limbs
* Unable to tolerate 30 min standing without clinical symptoms of orthostatic hypotension
* Unable to perform a sit-to-stand transfer or stand in the device with assistance
* Psychological or cognitive issues that do not allow a participant to follow the study procedures
* Any neurological condition other than SCI
* Medically unstable
* Severe comorbidities including any condition that a physician considers to not be appropriate to complete participation in the study
* Ongoing skin issues
* Height, width, weight or other anatomical constraints (such as leg length differences) incompatible with the device
* Insufficient Range of Motion (ROM) for ABLE Exoskeleton device
* Known pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04876794
Study Brief:
Protocol Section:
NCT04876794