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:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT04241003
Eligibility Criteria:
Inclusion Criteria:
* Capable of giving signed informed consent which includes compliance with the requirements listed in the informed consent form (ICF) and in this protocol
* 18 years of age inclusive, at the time of signing the informed consent.
* Motor level C6-L3 Spinal Cord Injury, American Spinal Injury Association Impairment Scale (AIS) A-C since at least six months
* Full time manual wheelchair users, able to propel their own wheelchairs independently
* Eligible reason for SmartDrive prescription (Self-reported shoulder pain, and/or decreased physical endurance for propulsion, limiting user from activity)
Exclusion Criteria:
* Cognitive impairment affecting the ability to operate the SmartDrive, as deemed by prescribing clinician
* Weigh more than 150 kilos due to the technical specification of the SmartDrive
* Currently participating in another clinical study anticipated to affect the outcome or ability to compete this study
* Planned change from daily routines during the following two months, such as holiday, move, change jobs
* For any other reason not suitable for participation in the study, as deemed by prescribing clinician
* Do not use a smart phone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04241003
Study Brief:
Protocol Section:
NCT04241003