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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04973059
Eligibility Criteria:
Inclusion Criteria:
* Active wheelchair user using a wheelchair as their primary means of mobility (at least 4 hours each day)
* 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.
* If the participant has a spinal cord injury 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:
* Uncontrolled exercise-induced asthma
* Heart condition or high blood pressure
* Chest pain at rest, during physical activity, or during physical activity
* Severe visual impairment that requires an attendant or guide dog
* Cognitive impairment affecting the ability to operate the SmartDrive, indicated by participant's clinician
* Weigh more than 150 Kg 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 measurement periods, such as holiday, move, change jobs
* For any other reason not suitable for participation in the study indicated by participant's clinician
* Do not use a smart phone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04973059
Study Brief:
Protocol Section:
NCT04973059