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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT07011420
Eligibility Criteria:
Inclusion Criteria:
* Unilateral transradial level limb absence
* Current or past user of myo-electric controlled prostheses
* Six months or more post-amputation
* Have adequate limb length such that a wrist rotation device can fit in the check socket
* Well-fitting socket as determined by a Socket-Comfort Score of 6 or above
* Capable of wearing and operating a prosthesis with a wrist rotator and multi-articulating hand
* Capable of understanding and following multi-step instructions and completing the tasks as described
* English speaking
Exclusion Criteria:
* Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
* Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07011420
Study Brief:
Protocol Section:
NCT07011420